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        "logicalDate": "1976-07-31",
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    "ocrText": "The original documents are located in Box 7, folder \"Medical Devices\" of the Spencer C.\nJohnson Files at the Gerald R. Ford Presidential Library.\nCopyright Notice\nThe copyright law of the United States (Title 17, United States Code) governs the making of\nphotocopies or other reproductions of copyrighted material. The Council donated to the United\nStates of America his copyrights in all of his unpublished writings in National Archives collections.\nWorks prepared by U.S. Government employees as part of their official duties are in the public\ndomain. The copyrights to materials written by other individuals or organizations are presumed to\nremain with them. If you think any of the information displayed in the PDF is subject to a valid\ncopyright claim, please contact the Gerald R. Ford Presidential Library.\nVENT\nDigitized from Box 7 of Spencer C. Johnson Files at the Gerald R. Ford Presidential Library\nDEPARTMENT OF HEALTH, EDUCATION. AND WELFARE\nSTATE\nUSA\nThe Honorable Harrison A. Williams, Jr.\nChairman, Committee on Labor and\nDRAFT\nPublic Welfare\nUnited States Senate\nWashington, D.C. 20510\nDear Mr. Chairman:\nWe would Tike to offer our comments on the House and Senate versions of\nthe Medical Device Amendments to the Federal Food, Drug, and Cosmetic\nAct (H.R. R. 11124 and S. 510).\nThese bills are similar in substance and would require premarket approval\nof certain medical devices and authorize establishment of performance\nstandards for others. The bills would also strengthen the authority of\nthe Food and Drug Administration (FDA) to take regulatory action against\nhazardous or deceptive medical devices, to prescribe good manufacturing\npractice regulations, to inspect records, to register device manufacturers,\nand to require maintenance of records and submission of reports concerning\nthese products.\nDuring Congressional consideration of these bills, the Department\npresented a number of statements and Departmental reports supporting\nmedical device legislation. These bills would remedy weaknesses in\nFDA's present authority that have prevented the Agency from keeping pace\nwith safety and effectiveness questions posed by increasingly complex\nnew medical equipment.\nIn general, the Department prefers H.R. 11124, which is better drafted\nand, in most respects, provides FDA with better authority to protect\nconsumers. However, we recommend that the conferees consider adoption of\nthe following changes in H.R. 11124, which represent compromises between\nthe Senate and House versions. We offer no suggestion concerning the\npremarket approval provisions of the bills since we perceive no signi-\nficant substantive differences between them in this respect, except that\nH.R. 11124 contains preferable provisions for statutory classification\nof unique new devices into the premarket approval category.\nCustom Devices\nThe custom device provisions of S. 510 allow use by practitioners of\ncustom devices which fail to comply with standards or premarket approval\nrequirements, but not as a course of conduct on many patients. H.R. 11124\ncontains custom device provisions that lack a prohibition of use of a\nDRAFT\nGERALD\nPage 2 - The Honorable Harrison A. Williams, Jr.\nDRAFT\ncustom device as a course of conduct; the House committee report explains\nthat some practitioners need to use custom devices routinely and that\nabuse can be prevented by other provisions of the Federal Food, Drug,\nand Cosmetic Act. A possible compromise would be to provide that custom\ndevices shall only be used as a course of conduct under conditions\nprescribed in FDA regulations.\nGood Manufacturing Practice Regulations\nS. 510 offers a simpler procedure for promulgation of good manufacturing\npractice regulations than H.R. 11124. While both bills call for an\nopportunity for a hearing on good manufacturing practice regulations,\nH.R. 11124 also requires review by³a special advisory committee.\nBecause there would be ample opportunity for industry, consumers, and\nscientists to express their views on these regulations through comments\non the proposal, participation in any hearing, and FDA workshops and\nmeetings, the special advisory committee is unnecessary and, indeed, its\nreview would unnecessarily delay implementation of good manufacturing\npractice regulations.\nRecords and Reports\nAlthough we generally prefer the records and reports provisions of\nH.R. 11124, the bill should omit the special criteria for recordkeeping\nand reporting on class I (general controls) devices. No such limitation\nappears in S. 510, which requires any device manufacturer to submit to\nthe Secretary, upon request, technical data and other data or information\napplicable to its devices as may reasonably be required to carry out the\nFederal Food, Drug, and Cosmetic Act. As a compromise, we suggest that\nthe provisions of H.R. 11124 be adopted but that the limitation on\nrecords and reports concerning class I devices apply only to distributors\nand not to manufacturers of these devices.\nRestricted Devices\nThe \"restricted device\" provisions of H.R. 11124 are generally better\nthan the \"prescription device\" provisions of S. 510. However, H.R. 11124\nspecifically precludes FDA from restricting distribution or sale of a\ndevice to a category of physicians based on special training or experience.\nUnder S. 510, FDA could differentiate between categories of licensed\nphysicians if necessary to assure safe use of the device taking into\naccount its potentiality for harmful effect or the collateral measures\nfor its use. With the increasing sophistication of medical devices, it\nis important that FDA be able to consider the skill of intended users\nDRAFT\nPage 3 - The Honorable Harrison A. Williams, Jr.\nwhen it establishes conditions for marketing of a device. Accordingly,\nwe recommend that the conferees not adopt the language in H.R. 11124\nthat prevents FDA from restricting devices to a category of physicians\npossessing certain training or experience.\nProceedings of Advisory Committees\nWe question the advisability of the requirement in H.R. 11124 that\npanels and advisory committees maintain transcripts of their proceedings.\nWe believe that maintenance of transcripts should be optional rather\nthan mandatory, to promote full and frank discussion. We therefore\nrecommend that this provision of H.R. 11124 be deleted.\nOffice To Assist Small Manufacturers of Medical Devices\nThe Department is opposed to the statutory establishment of a separate\noffice within the Department of Health, Education, and Welfare to\nprovide technical and other non-financial assistance to small manu-\nfacturers of medical devices, as proposed in H.R. 11124. Legislative\nmandates of organizational structure result in rigidity and overlapping\nfunctions and limit the Secretary's ability and discretion to organize\nthe Department in the most effective manner to achieve its objectives.\nThe Department strongly favors enactment of medical device legislation\nand urges that the conferees adopt H.R. 11124, subject to the recommendations\nin this letter.\nWe were advised by the Office of Management and Budget that there is no\nobjection to the presentation of this report from the standpoint of the\nAdministration's program.\nSincerely,\nSecretary\nDRAFT\nHEALTH\nTHE SECRETARY OF HEALTH, EDUCATION, AND WELFARE\nM SEAL :\nWASHINGTON. D. C. 20201\n0 9 MAR 1976\nThe Honorable Harley O. Staggers\nChairman, Committee on Interstate\nand Foreign Commerce\nHouse of Representatives\nWashington, D. C. 20515\nDear Mr. Chairman:\nYour Committee, on January 21, 1976, ordered reported H.R. 11124, a bill\n\"To amend the Federal Food, Drug, and Cosmetic Act to provide for the\nsafety and effectiveness of medical devices intended for human use.\"\nWe have previously, by a letter dated February 5, 1976, provided our\ngeneral views in support of this legislation. A copy of that letter is\nattached for your reference. We promised at that time to provide you\nwith a more detailed analysis outlining some of the specific concerns we\nhave with the bill. That analysis is enclosed for your information. We\nwould appreciate it if our earlier letter as well as the enclosed analysis\ncan be made a part of the permanent record of your Committee's considera-\ntion of this bill.\nWe recommend that the bill, amended as we have proposed in the accompany-\ning analysis, be favorably considered by the Congress.\nWe are advised by the Office of Management and Budget that there is no\nobjection to the presentation of this report from the standpoint of the\nAdministration's program.\nThrongone Sincerely, Rynh\nUnder Secretary\nEnclosures\nANALYSIS OF H.R. 11124\n1. Classification of Devices Intended for Human Use\nWe favor the provisions of the proposed new section 513 to the Federal\nFood, Drug, and Cosmetic Act which would provide for classification by\nthe Food and Drug Administration (FDA) of all medical devices intended\nfor human use. The proposed classification system is consistent with\nthe 1970 recommendations of the Committee established by this Department,\nand chaired by Theodore Cooper, M.D., the present Assistant Secretary\nfor Health, to make recommendations on the most appropriate means to\nassure the safety and effectiveness of medical devices.\nShortly after the Cooper Committee Report, FDA was requested by former\nSecretary Elliot Richardson to initiate the proposed medical device\nclassification process. To date, FDA has classified approximately 3,000\ndevices. This work will be of significant value in classifying devices\nunder this legislation.\n2. Performance Standards\nH.R. 11124 would add a new section 514 to the Act which would establish\na procedure for promulgating performance standards for those devices for\nwhich general controls are insufficient to assure their safe and effective\nperformance, and for which sufficient information exists to establish\nstandards.\nWe believe that the procedure for the promulgation of a performance\nstandard as set forth in this section could be improved. The present\nprocedure would require the publication of two separate notices for\ncomments: one publication of a notice for the submission of comments\nconcerning the establishment of a standard (proposed section 514(b)),\nand a second publication requesting submission of offers to develop a\nproposed standard (proposed section 514(c)). We recommend that the two\nsteps be combined into one publication providing for the solicitation of\nboth comments on the need for a standard and the submission of offers to\ndevelop a standard.\nIn our testimony, we also expressed concern that the section providing\nfor review of a device standard by an independent advisory committee\nshould be amended. Under proposed section 514(g)(5)(B), as well as\nunder proposed section 515(g)(2)(B), the Agency cannot use the panels\n(who advise on classification and premarket approval) as the independent\nadvisory committee used for administrative review of proposed standards\nand of premarket approval decisions. We urged that section 514(g)(5)(B)\nbe amended to allow FDA to merely disqualify those panel members who may\nhave prejudged an issue from service on an independent review advisory\ncommittee. The Subcommittee staff has assured us that provisions in\n- 2 -\nsection 514 (g) (5) (B) are intended merely to prohibit the use of the\nentire classification panel that had considered a device as the in-\ndependent advisory committee for review of a device standard or premarket\napproval decision and that the provisions do not bar use of individual\nmembers of a panel as members of the independent advisory committee. We\nagree with this interpretation and, if it is correct, agree that the\nbill need not be amended.\n3. Premarket Approval\nPremarket approval would be required under proposed section 515 for\ndevices that are of substantial importance in supporting, sustaining or\npreventing impairment of human life or health, or present a potential\nunreasonable risk of illness or injury, and for which insufficient\ninformation exists to provide reasonable assurance of safety and\neffectiveness under general controls, or general controls and perform-\nance standards, alone.\nWe believe that the requirement for premarket approval in H.R. 11124 is\ntoo broad and that the criterion of unreasonable risk to health and the\nsubstantial importance of supporting, sustaining, or preventing the\nimpairment of human life or health should be met before requiring premarket\napproval. Accordingly, we recommend that the word \"or\" be changed to\n\"and\" in section 513(a)(1)(C)(ii)(I).\nIn our testimony, we recommended that the provision for opportunity for\na formal evidentiary hearing, as an alternative to independent advisory\ncommittee review of premarket approval decisions, be amended to provide\ninstead for an opportunity for an informal hearing (as defined in\nsection 3 of the bill). This recommendation was based on FDA's experi-\nence in removing unsafe and ineffective drugs from the market under a\nsimilar requirement in current drug law. However, during Subcommittee\nmarkup of the bill, Subcommittee staff explained that orders which are\nsubject to review under section 515(g)(1) of the bill would take effect\nupon issuance, after merely an informal hearing and pending further\nproceedings. Thus, withdrawal orders would take effect prior to the\nformal evidentiary hearing or the review by an independent advisory\ncommittee. This understanding, coupled with the substitution of\n\"questioning\" for \"cross-examination\" at informal hearings, addresses\nour concerns about unwarranted delays in terminating marketing of\ndevices subject to section 515.\n4. Banned Devices\nWe support the change in proposed new section 516 to provide that, under\nspecified circumstances, the ban of a device shall take effect upon\npublication and pending any further proceedings.\n- 3 -\n5. Records and Reports\nAt the hearing, we urged that the records and reports section\n(section 519(a)(1)) be simplified by deletion of the provision barring\n\"requirements unduly burdensome to a device manufacturer, importer or\ndistributor taking into account his cost of complying with such require-\nments and the need for the protection of the public health and the\nimplementation of this Act.\" This language is unnecessary, would\nengender controversy, and would not add any real safeguards to assure\nthat burdensome requirements are not imposed. We also expressed concern\nthat the restrictions in section 519(a)(5) upon FDA's authority to\nrequire reports for devices subject only to general controls may be\nmisunderstood. We read these requirements as only restricting use by\nFDA of the reporting authority to require that research be conducted\nthat will generate data meeting FDA reporting requirements, or to\nrequire routine periodic reporting unrelated to public health needs,\nexcept where necessary to determine if the device should be reclassified\nor if the device is adulterated or misbranded. While the records and\nreports provisions of H.R. 11124 are superior to those in S. 510, the\nSenate version of the legislation, we believe they can be further\nimproved by the amendments we suggest.\nAlthough we also recommended amending section 519(b)(2) to provide that\nresearchers and teachers who directly import devices for their own use\nbe subject to section 519 recordkeeping and report requirements, such an\namendment is no longer necessary because of clarifying amendments to the\ninvestigational provisions of the bill which assure recordkeeping and\nreporting by researchers.\n6. Custom Devices\nWe support the objective of the provision allowing marketing of custom\ndevices, under proposed new subsection 520(b), that necessarily deviate\nfrom requirements which would otherwise be applicable under a standard\nor the premarket approval provisions of the bill. However, it is\nessential that the custom device provisions not become a loophole that\nwill allow the marketing of dangerous or deceptive products. Section 520(b)\nwould not, as we read the bill, exempt any device from otherwise applicable\nregulations for investigational devices, banned devices, or restricted\ndevices. It should also be made clear that FDA would be able to take\nnecessary action to curb a practitioner's use of a custom device on\nseveral patients, where this use is repeated to such an extent that the\npractitioner is in effect conducting unsupervised experiments, or\nallowing the marketing of a product that would otherwise be unlawful.\nWe recognize the difficulty of drafting a provision limiting use of\ncustom devices as a course of conduct that prevents abuses, but does not\nprevent use of custom products where justified by medical need. FDA\nwill endeavor to strike the necessary balance in its regulations\nimplementing section 520(b).\n- 4 -\n7. Restricted Devices\nWe are seriously concerned about a provision adopted during Subcommittee\nmarkup of the bill which would curb FDA's authority to restrict use of a\nmedical device to a subcategory of physicians based on training and\nexperience when necessary to provide reasonable assurance of a device's\nsafety and effectiveness. This provision will seriously undermine the\nAgency's ability to reduce public exposure to medical devices that may\nbe unsafe in the hands of practitioners who lack the training or experience\nto use them. Also, the effect of H.R. 11124 may be to discourage FDA\napproval for commercial marketing of products that will provide great\nbenefits to patients when used by skilled practitioners, but which\npresent unreasonable risk to patients if used too widely by the un-\ntrained. FDA may have to retain investigational controls over devices\nfor a lengthy period of time, since section 520(g), unlike section\n520(e), authorizes FDA to distinguish between categories of physicians\nbased on qualifications. To assure that a device can be marketed safely\nand effectively, FDA may also have to resort to its present authority\nunder section 502(f) of the Act, to require adequate directions for use\nand promulgate conditional exemptions from this requirement. We therefore\nrecommend deletion of the phrase \"(other than any condition which would\nlimit the use of a device to a particular category or categories of\nphysicians based on their training and experience).\" This matter is a\nserious concern with the increasing sophistication of medical devices.\n8. Good Manufacturing Practice Advisory Committee\nWe still believe that it is unnecessary to require establishment of a\nseparate advisory committee to advise FDA concerning good manufacturing\npractice regulations. FDA's present procedures provide ample opportunity\nfor industry, consumers, and scientists to make known their views in\nthis area. If a specific advisory committee on good manufacturing\npractice regulations seems desirable, we will establish one. Moreover,\nthe Department is opposed generally to the statutory establishment of\nadvisory committees since it tends to result over time in the existence\nof unnecessarily rigid committees which have outlived their usefulness.\nWe note that Congress supported this view in the Federal Advisory Committee\nAct.\n9. Proceedings of Advisory Panels and Committees\nWe question the advisability of the amendment adopted by the Subcommittee,\nnew subsection 520(i), that advisory panels and committees maintain\ntranscripts of their proceedings. It is FDA's policy to allow its\ncommittees to decide for themselves whether they wish to have transcripts\nor tapes made of their meetings as an aid to preparation of minutes, as\nset forth in proposed section 2.313 of Title 21, Code of Federal\nRegulations in FDA's proposed procedural regulations (Federal Register\nof September 3, 1975, 40 FR 40748). This policy has been maintained to\n- 5 -\nprotect the free interchange of ideas by these advisors. This concept\nthat internal communications of Government employees may be exempted\nfrom public disclosure so as to promote full and frank discussion is set\nforth in the Freedom of Information Act as incorporated into the Federal\nAdvisory Committee Act. We believe it consistent with this policy that\nmaintenance of transcripts be optional rather than mandatory. We\ntherefore recommend that this provision be deleted.\n10. HEW Office to Provide Technical Assistance to Small Manufacturers\nof Medical Devices\nThe Department is opposed to the statutory establishment of a separate\noffice within HEW to provide technical and other nonfinancial assistance\nto small manufacturers of medical devices. Legislative mandates of\norganizational structure result in rigidity and overlapping functions\nand limit the Secretary's ability and discretion to organize the Depart-\nment in the most effective manner to achieve its objectives.\nSERAL\nDEPARTMENT OF HEALTH, EDUCATION. AND WELFARE\nThe Honorable Harley O. Staggers\nChairman, Committee on Interstate\nFEB 1976\nand Foreign Commerce\nHouse of Representatives\nWashington, D. C. 20515\nDear Mr. Chairman:\nThere is before your Committee, as reported by the\nSubcommittee on Public Health and Environment on\nNovember 13, 1975, H.R. 11124, the \"Medical Device\nAmendments of 1975.' The reported bill is a clean bill\nin lieu of H.R. 5545 as amended by the Subcommittee.\nThe Department of Health, Education, and Welfare supported\nlegislation similar to H.R. 11124 in the Ninety-third\nCongress and has long endorsed the need for modernizing\nthe authority of the Food and Drug Administration (FDA)\nover medical devices. We also presented testimony generally\nfavorable to H.R. 5545 at hearings before the Subcommittee\non July 28, 1975. Provided that it is amended to meet a\nfew continuing concerns outlined in an analysis which we\nwill shortly forward to your attention, the Department\nvigorously supports H.R. 11124 as a balanced response to\nthis need.\nIf H.R. 11124 were enacted, FDA would use both existing\nresources and a substantial part of the $17 million\nrequested increase for the Agency in the President's\n1977 budget to implement a strengthened medical device\nregulation program.\nA number of changes made in the Subcommittee simplified\nand thus improved administrative proceedings under the\nbill. We favor, among other changes, the amended\ninvestigational device provisions, the transitional\nprovisions for projects formerly categorized as \"drugs,\"\nthe substitution of \"questioning\" for \"cross-examination\"\nat informal hearings, the provisions requiring FDA to make\nThe Honorable Harley O. Staggers\n2\npublic a detailed summary of safety and effectiveness\ninformation respecting certain devices, the exemption\nof class I, General Control devices, from the biennial\ninspection provision, and the understanding that the\nrestricted device provisions apply both as to effectiveness\nas well as safety of a device.\nIn each of the areas where H.R. 11124 would strengthen\nFDA's current authority, the Agency has been operating\nunder serious handicaps because of lack of legislative\nauthority to enable the Agency to keep pace with the\nburgeoning growth in the introduction of complex new\nmedical equipment for use on or in humans.\nWe understand that certain industry representatives are\nurging your Committee to use H.R. 11124 as a vehicle for\namending the criminal liability provisions of the Federal\nFood, Drug, and Cosmetic Act with respect to all products\nsubject to the Act, not just medical devices. This subject\nwas never raised by any witness or member of the Subcommittee\nat hearings on the device legislation. This Department\nstrongly opposes any amendment to the criminal liability\nprovisions of the Act. Our position has been set forth in\nprior testimony and is summarized in the appended enclosure.\nThe present criminal liability provisions have been\nconsistently upheld by the courts and most recently by\nthe Supreme Court in United States V. Park, 421 U.S. 658\n(1975) The present criminal liability standard is also\nsupported by consumer and public interest organizations.\nWe would even venture to question the unanimity within the\nvarious regulated industries as to whether the long\nestablished strict criminal liability standard should\nbe amended. Finally, of course, there is some question\nas to whether an amendment to the criminal liability\nprovisions respecting all products subject to the Act may\nbe considered germane to medical device legislation.\nThe Honorable Harley O. Staggers\n3\nWe are advised by the Office of Management and Budget nat\nthere is no objection to the presentation of this report\nfrom the standpoint of the Administration's program.\nSincerely,\n/s/Marjorie Lynch\nUnder Secretary\nEnclosure\nGERALD\nSTRICT CRIMINAL LIABILITY\nThe provisions of the Federal Food, Druq, and Cosmetic Act that define\ncriminal violations do not make knowledge or intent elements of the\noffense. Rather, 21 U.S.C. §331 prohibits the enumerated \"acts and the\ncausing thereof.\"\nMore than thirty years ago, in the Dotterweich case, the Supreme Court\ndeclared, \"[this] legislation dispenses with the conventional require-\nment for criminal conduct--awareness of wrongdoing\" and punishes individuals\n\"though consciousness of wrongdoing be totally wanting.\" And since 1943\nthe Court has reaffirmed this interpretation on several occasions. Last\nyear when a divided Court of Appeals for the Fourth Circuit rejected the\nstandard it was quickly and unreservedly reversed by the Supreme Court\nin the Park case.\nThere is no constitutional prohibition against punishing persons who\nviolate certain classes of laws (of which public health laws, including\nthe Act, are a principal example) even though they acted in good faith\nor were ignorant of the facts which comprised the violation. The issue,\ntherefore, is whether such a standard serves a legitimate public purpose.\nAs Mr. Justice Frankfurter stated in Dotterweich:\n\"Hardship there doubtless may be under a statute which thus\npenalizes the transaction though consciousness of wrongdoing be\ntotally wanting.\nBalancing relative hardships, Congress has preferred to place\nit upon those who have at least the opportunity for informing\nthemselves of the existence of conditions imposed for the protection\nof consumers before sharing in illicit commerce, rather than to\nthrow the hazard on the innocent public who are wholly helpless.\"\nThe same reasoning was more recently echoed by Chief Justice Burger in\nhis opinion for the Court in the Park case.\nFDA believes strongly that the strict liability standard is an indis-\npensable adjunct to its efforts to enforce the Act. The dimensions of\nthe agency's enforcement responsibilities are dramatized by a glance at\nthe food industry as an example. There are approximately 60,000 food\nfactories and warehouses in the United States and fewer than 1000 FDA\ninspectors (many of whom are assigned full-time to other duties).\nInspections must, of necessity, be sporadic. It is clear therefore that\nthe purity of the nation's food supply rests, in the first instance, in\nthe hands of food producers and processors.\nFORD & LIBRARY GERALD\n2\nSince the civil remedies available to FDA (seizure and injunction actions)\nare essentially retrospective in effect, regulated firms can, and often\ndo, simply sit back and wait for FDA to act. It is far cheaper to risk\nthe loss of a few hundred or thousand dollars as a result of an occasional\nseizure or injunction than to regularly allocate the resources necessary\nto fully comply with the requirements of the Federal Food, Drug, and\nCosmetic Act. The primary impetus to self-regulation is the fear that\ncriminal prosecution may result from failure to take every precaution to\nensure that violations--and their potentially harmful consequences to\nhealth--will not occur.\nTHE WHITE HOUSE\nACTION MEMORANDUM\nWASHINGTON\nLOG NO.:\nDate: May 21\nTime:\n530pm\nJack Marsh\nFOR ACTION: Spencer Johnson\nCC (for information):\nJim Cavanaugh\nDavid Lissy\nEd Schmults\nRobert Hartmann (signing statement attached)\nMax Friedersdorf\nKen Lazarus\nFROM THE STAFF SECRETARY\nDUE: Date:\nTime:\nMay 24\n400pm\nSUBJECT:\nS. 510-Medical Device Amendments of 1976\nACTION REQUESTED:\nFor Necessary Action\nFor Your Recommendations\nPrepare Agenda and Brief\nDraft Reply\nFor Your Comments\nDraft Remarks\nX\nREMARKS:\nPlease return to Judy Johnston, Ground Floor West Wing\nCencur- I\n1) See remd changes in statement\n2) signing ceremony\nPLEASE ATTACH THIS COPY TO MATERIAL SUBMITTED.\nIf you have any questions or if you anticipate a\ndelay in submitting the required material, please\nDRAFT MESSAGE FOR THE PRESIDENT\nToday, I have the pleasure of signing into law the\nMedical Device Amendments of 1976 to the Federal Food,\nDrug, and Cosmetic Act of 1938.\nIt is almost exactly 70 years since President Theodore\nRoosevelt signed the Pure Food and Drugs Act of 1906,\nthe nation's first federal food and drug legislation designed\nto protect the American consumer against health threats arising\nfrom harmful substances and deceptive practices. Since then,\nthere have been a number of actions to strengthen and update\nthe structure of protection sought by President Roosevelt.\nWhile we as a nation were able to take justifiable\npride in the laws providing for safety, honesty and efficacy\nin the foods and drugs we consume, it became increasingly\nclear that there remained a large, significant and growing\ngap in that security.\nUntil today, the American consumer could not be sure\nthat a medical device used by his physician, his hospital,\nor himself was as safe and effective as it could or should be.\nIn 1906, President Roosevelt had no need to ask for\nlegislation concerning medical devices; for the devices\nused by physicians of his day were comparatively simple.\nThey stood at the edge of medicine, helpful but not essential,\nand, therefore, posed no regulatory need.\nBy the 1960's, however, enormous advances in science\n-2-\nand technology moved medical devices from the edge close\nto the center of the stage. Today devices are routinely\nimplanted in our bodies. They replace limbs, bones,\ntissues, even entire organs. They permit treatment of\nforms of illness that can be accomplished in no other way.\nThey magnify and speed ten thousandfold the diagnostic\npower of the human eye and brain.\nMedical and diagnostic devices have produced a thera-\npeutic revolution, but in doing so, they have also become\nmore complex and less easily understood by those who use\nthem. When well designed, well made, and properly used\nthey support and lengthen life. If poorly designed, poorly\nmade, and improperly used they can threaten and impair it.\nDespite the increasing importance of devices, the Food\nand Drug Administration has had inadequate authority to deal\nwith them. FDA has had no reliable way of knowing how many\ndevices there are, who is making them, who is selling them,\nwhat injuries they can cause, and when a manufacturer has\nfound it necessary to remove them from the medical market-\nplace.\nIn addition, no device was required to be proven safe\nand effective prior to marketing, no matter how crucial it\nmight be to the person using it,\neven if that use involved\nimplantation in his body.\n-3-\nRecognizing these and other deficiences, the\nAdministration ordered a study of the problem in 1969\nand subsequently asked Congress to enact remedial legislation.\nIn its deliberations since that time, Congress benefited\ngreatly from the cooperation voluntarily extended by the\nmedical device industry who clearly saw the need for legislation\nthat would protect the consumer as well as the manufacturer\nwho refused to compromise with safety. Representatives\nof consumers and health professionals also played an\nimportant role.\nThe Medical Device Amendments of 1976 eliminate the\ndeficiencies that accorded FDA \"horse and buggy\" authority\nto deal with \"laser age\" problems. It is important not only\nin what it will do to protect the consumer; it is also\nimportant as a symbol for the kind of regulation that I feel\nis most appropriate to government. It does not represent\nanother expansion of government into affairs we might better\nmanage ourselves. Instead, this is an example of government\ndoing for the individual citizen what he or she cannot do\nunaided.\nI welcome this legislation and commend the FDA who\nidentified the need, cooperated in its development, and\nfinally, will be entrusted with its enforcement.\n-4-\nThis agency daily faces a most difficult task --\npreventing threats to the public health in a way that is not\nonerous, but fully consonant with the principles of competi-\ntive economic development on which this nation was built.\nIt is a task that requires determination, scientific skill,\njudgement and most of all, compassion for the hopes and\nneeds of our fellow man. Dr. Alexander M. Schmidt,\nCommissioner of Food and Drugs, has effectively taken\non the job of assuring that the hope and expectations\nof the consumer for life giving drugs and devices are not\nfalse promises.\nI reaffirm my support for the fine work of the\nFood and Drug Administration and the job ahead.\nEXECUTIVE OFFICE OF THE PRESIDENT\nOFFICE OF MANAGEMENT AND BUDGET\nWASHINGTON, D.C. 20503\nMAY 21 1976\nMEMORANDUM FOR THE PRESIDENT\nSubject: Enrolled Bill S. 510 - Medical Device Amendments\nof 1976\nSponsor - Sen. Kennedy (D) Mass. and 8 others\nLast Day for Action\nMay 28, 1976 - Friday\nPurpose\nProvides new authority to the Secretary of Health,\nEducation, and Welfare to assure the safety and effective-\nness of medical devices intended for human use.\nAgency Recommendations\nOffice of Management and Budget\nApproval\nDepartment of Health, Education,\nand Welfare\nApproval (Signing\nstatement attached)\nVeterans Administration\nApproval\nDepartment of Commerce\nNo objection\nDepartment of Justice\nNo objection\nDepartment of Defense\nDefers to HEW\nDiscussion\nS. 510 would amend the Federal Food, Drug and Cosmetic\n(FDC) Act of 1938 to provide the Food and Drug Administra-\ntion (FDA) in the Department of Health, Education, and\nWelfare (HEW) with significant new authority to regulate\nthe safety and effectiveness of medical devices. The\nenrolled bill is the first amendment to the FDC Act since\n1938 dealing with medical devices and represents several\nyears of work by the Executive branch and the Congress to\ndevelop acceptable legislation to assure that modern\nmedical devices are safe and effective.\n2\nBackground. FDA's current regulatory authority under the\n1938 Act is limited to action after a medical device has\nbeen offered for introduction into interstate commerce and\nonly when the device is deemed to be \"adulterated\"\n(i.e., unsterile) or \"misbranded\" (i.e., not properly\nlabelled). Once a device has been determined to be in\nviolation of the Act, the FDA is limited to seeking seizure\nof the device by court order, seeking an injunction against\nthe violation, or recommending criminal prosecution.\nThe 1938 provisions were directed toward relatively simple\ndevices, such as surgical instruments, prosthetic devices,\nand ultraviolet lights whose safety or proper functioning\ncould generally readily be determined by experts. It was\nalso directed at protecting the public against quack\nmachines and other fraudulent devices. The major concern\nwith devices at the time the 1938 Act was enacted was\nassuring truthful labeling.\nSince then, rapid technological change in the medical device\nfield has led to the introduction of many highly sophisticated\nmodern devices, such as heart pace-makers, kidney dialysis\nunits and artificial blood vessels and heart valves. These\ndevices are so intricate and complex that skilled health\nprofessionals are unable to ascertain whether they are\ndefective without careful and thorough testing. Even\nwhere devices are determined by FDA to be unsafe or of\nquestionable effectiveness, lengthy court proceedings are\nusually required to remove such devices from the market.\nIn Congressional hearings on S. 510 and related bills, FDA\ntestified that litigation in some cases lasted for five to\nseven years costing the Federal Government several millions\nof dollars. To avoid such extensive court battles, FDA\nhas resorted to classifying certain products, e.g., soft\ncontact lenses, pregnancy kits, and intrauterine contra-\nceptive devices, as drugs if the intended reaction is\nchemical, or if the potential hazards of the product may\nbe reduced through drug controls, since FDA exercises pre-\nmarket clearance authority over drugs (but not devices)\nunder the FDC Act. Moreover, according to HEW, many unsafe\ndevices which cannot technically be found to be in\nviolation of the adulteration or misbranding provisions\nof the FDC Act lie outside the range of FDA's regulatory\nauthority. S. 510 would eliminate the need for lengthy\ncourt proceedings to remove unsafe or ineffective devices\nfrom the market.\n3\nThe detailed provisions of the bill are explained in\nHEW's attached views letter and in the accompanying\nCongressional committee reports on the measure.\nClassification of Devices. S. 510 would classify all\nmedical devices intended for human use into three categories\nbased upon the extent of control necessary to insure the\nefficacy and safety of each such device:\n(1) general controls (Class I) -manufacturer registra-\ntion, recordkeeping and reporting requirements, good\nmanufacturing practice regulations, etc. , would be established\nfor devices for which such controls would be adequate to\nassure safety and efficacy;\n(2) performance standards (Class II) - HEW would\ndevelop and issue performance standards for those devices\nfor which general controls would be inadequate and for\nwhich performance standards can be devised; and\n(3) premarket approval procedures (Class III) --\nmanufacturers would be required to submit safety and\nefficacy data to HEW before marketing a device where\ninsufficient information exists to assure that general\ncontrols and performance standards would provide reasonable\nassurance of the safety and effectiveness of devices, and\nwhere such devices are purported or represented for a use\nin supporting or sustaining human life or for a use which\nis of substantial importance in preventing impairment of\nhuman health, or which present a potential unreasonable\nrisk of illness or injury.\nThe bill would authorize the Secretary to ban devices\nintended for human use which presented substantial deception\nor an unreasonable and substantial risk of illness or\ninjury.\nS. 510 would regulate device marketing through the classi-\nfication system, i.e., by authorizing HEW to classify\ndevices in one of the three specified categories. Manu-\nfacturers would be permitted to file applications for the\napproval of devices in Classes I, II, or III, and the HEW\nSecretary would be empowered to either approve or deny the\napplications through the issuance of orders. Manufacturers\nand other applicants adversely affected by the HEW regula-\ntions or orders would be permitted to appeal such decisions\nto the appropriate United States Court of Appeals.\n4\nGeneral Provisions. In addition to prescribing detailed\nprocedures for the classification of devices and the\njudicial review of regulations and orders, S. 510 contains\na number of general provisions dealing with the regulation\nand control of medical devices for human use. Briefly,\nthe bill would:\n-- provide an exception for certain \"custom devices\"\nand devices used in investigational use;\n-- authorize HEW to issue good manufacturing practice\nrequirements;\n-- provide for the release of safety and effectiveness\ninformation to the public;\n-- require advisory panels and committees to maintain\ntranscripts of any proceedings;\n-- authorize HEW to enter into contracts for research,\ntesting and demonstrations of devices;\n--- provide for Federal preemption of State and local\nrequirements for medical devices;\n-- require the registration and inspection (every two\nyears) of manufacturers of Class II and Class III devices;\n-- provide for the temporary administrative detention\nof devices in violation of the FDC Act;\n-- authorize HEW to provide trade secrets and other\nconfidential information to persons under contract with\nthe Secretary;\n-- establish a presumption of existence of connection\nwith interstate commerce required to establish jurisdiction\nin legal actions to enforce the Act with respect to devices;\n-- require HEW to establish an office to provide\ntechnical and other nonfinancial assistance to small\nmanufacturers to assist them in complying with the Act.\nCosts. As indicated above, HEW already undertakes some\nmedical device regulatory activity. The following table\nshows current and HEW's proposed supplemental funding\nlevels if you approve S. 510:\nGERALD\n5\nBudget Authority\n(In $ millions)\n1976\nactual\n1977\n1978\n1979\nHEW current activity\nlevel projected\n8.2\n9.4\n23.1\n36.7\nHEW proposed funding\nfor S. 510 authorities\n--\n13.6\n13.6\n13.4\n8.2\n23.0\n36.7\n50.1\nProposed position levels 281\n723\n1,013\n1,428\nWe have not had an opportunity to review the HEW estimates\nand HEW Under Secretary Lynch states in the Department's\nletter:\n\"I recognize that in earlier correspondence with\nthe Congress we indicated that no funds beyond the\nPresident's Budget would be sought to implement this\nactivity in fiscal year 1977. Nevertheless, I would\nlike to retain the option of submitting a supple-\n:\nmental request for your consideration.\nRecommendation\nHEW fully supports enactment of S. 510. The Department\nnotes that it has worked with the Congress for several\nyears to perfect the legislation and that \"In its present\nform, the bill embodies nearly all of the amendments\nsuggested by the Department and combines the best features\nof the Senate and House-passed versions.\" HEW has prepared\na draft signing statement for your consideration and\nrecommends a signing ceremony.\n********\nS. 510 is similar to medical device legislation submitted\nby the Executive branch to the 93rd and prior Congresses.\nIt represents Administration proposals and is strongly\nsupported by HEW, the medical device industry and the\nCongress--an unusual display of unanimity. Accordingly,\nwe recommend that you approve S. 510 with a signing statement\nalong the lines of the one proposed by HEW.\nJames Director for\nLegislative Reference\nEnclosures\nTHE\nACKIT\nE\nDEPARTMENT OF HEALTH, EDUCATION. AND WELFARE\nDETAR\nUSA\nThe Honorable James T. Lynn\nDirector, Office of Management\nMAY\n20 1976\nand Budget\nWashington, D. C. 20503\nDear Mr. Lynn:\nThis is in response to your request for a report on S. 510,\nan enrolled bill \"To amend the Federal Food, Drug, and\nCosmetic Act to provide for the safety and effectiveness\nof medical devices intended for human use, and for other\npurposes. \"\nIn short, the Department recommends enactment of this bill\nbecause it is a well balanced and meticulously formulated\npiece of legislation which properly addresses an important\naspect of public health and safety protection, without unduly\nrestricting an innovative and important health industry.\nThe enrolled bill is summarized in detail at Tab A. Briefly\nstated the bill would amend the Federal Food, Drug, and\nCosmetic Act to provide the Secretary of Health, Education,\nand Welfare with a basis for a comprehensive program to\nprotect the public from unsafe or ineffective medical devices.\nIt would require premarket approval of certain medical devices,\nand permit promulgation of performance standards to assure\nsafe and effective performance of others for which premarket\napproval is not needed. It would also provide new or\nstrengthen existing authority to prescribe good manufacturing\npractice regulations; require registration of device manu-\nfacturers; authorize the Secretary to take remedial action\nagainst devices presenting an unreasonable risk of substantial\nharm to the public health; require maintenance of records\nand submission of reports; and authorize the Secretary to\ninspect records, processes, controls and facilities of\nestablishments which manufacture restricted devices.\nThe Honorable James T. Lynn\n2\nThe bill presents a balanced regulatory framework incorporating\nthe basic principle that the least regulation consistent\nwith public health protection is the best. General controls\n(e.g., manufacturer registration, recordkeeping and reporting\nrequirements, and good manufacturing practice regulations)\nare preferred to performance standards, and performance\nstandards are preferred to premarket approval, where\ngeneral controls, or general controls and standards, can\nprovide reasonable assurance of device safety and effective-\nness. This regulatory framework would assure, on the one hand,\nadequate protection to the public, including health pro-\nfessionals, from unsafe and ineffective medical devices,\nand, on the other, that advances in the state of the art of\nmedical device technology would not be stifled by unnecessary\nregulatory restrictions.\nThe bill recognizes the need to minimize any potential economic\nimpact on the medical device industry, especially the small\nmanufacturers who have been responsible for the development\nof many new and innovative devices. It would provide the\nSecretary with the authority to exempt, consistent with\nthe protection of public health, certain devices subject\nto general controls from the requirements of registration,\nrecordkeeping and reporting, and good manufacturing practices,\nwhile requiring adherence to other regulatory requirements\nsuch as the prohibitions of misbranding and adulteration.\nIn each of the areas where S. 510 would strengthen our current\nauthority we have been operating under a serious handicap.\nLegislative authority to keep pace with the ever increasing\nvariety of complex new medical equipment being introduced\nfor use on, or for implantation in, the body is long overdue.\nThe Department has fully supported enactment of S. 510,\nboth in testimony and in reports, and has worked with the\nCongress for several years to perfect the legislation.\nIn its present form, the bill embodies nearly all of the\namendments suggested by the Department and combines the best\nfeatures of the Senate and House-passed versions.\nThe Honorable James T. Lynn\n3\nFor the reasons given, we urge that the enrolled bill be\napproved.\nThe amendments are a fine tribute to the diligent and tire-\nless efforts and cooperation of a number of highly publicly\nmotivated individuals representing the Administration,\nCongress, consumers, health professionals, and industry.\nA ceremony for the signing of the medical device amendments\nby the President would be a most fitting recognition of\nthe importance of this legislation.\nWe have enclosed at Tab B, for your information, preliminary\ncost estimates for the bill. The projection includes a 1977\nsupplemental. I recognize that in earlier correspondence\nwith the Congress we indicated that no funds beyond the\nPresident's Budget would be sought to implement this activity\nin fiscal year 1977. Nevertheless, I would like to retain the\noption of submitting a supplemental request for your\nconsideration. A draft signing statement may be found at\nTab C.\nSincerely,\nMarjone bynch\nUnder Secretary\nEnclosures\nSUMMARY OF THE PROVISIONS OF ENROLLED BILL S. 510\nClassification of Medical Devices Intended for Human Use\nSection 2 of the enrolled bill would amend the Federal Food,\nDrug and Cosmetic Act (hereinafter referred to as \"the Act\")\nby adding a new section 513, which would classify all medical\ndevices intended for human use into three categories based\nupon the extent of control necessary to insure the safety and\nefficacy of each such device. The three categories are:\n(1) Class I, General Controls (e.g. manufacturer registra-\ntion, recordkeeping and reporting requirements, and good\nmanufacturing practice regulations) - devices for which controls\nother than standard-setting and premarket approval are\nsufficient to assure safety and effectiveness or for which\ninsufficient information exists to determine that general\ncontrols are sufficient but which are not purported or\nrepresented to be for a use in supporting or sustaining\nhuman life or for a use which is of substantial importance\nin preventing impairment of human health and which do not\npresent a potential unreasonable risk of illness or injury;\n(2) Class II, Performance Standards - devices for which\ngeneral controls are insufficient to provide reasonable\nassurance of safety and effectiveness and for which there\nis sufficient information to establish a performance standard\nto provide such assurance; (3) Class III, Premarket Approval -\ndevices for which insufficient information exists to assure\nthat general controls and performance standards would provide\nreasonable assurance of safety and effectiveness and which\nare purported or represented to be for a use in supporting\nor sustaining human life or for a use which is of substantial\nimportance in preventing impairment of human health, or\nwhich present a potential unreasonable risk of illness or\ninjury.\nNew section 513 of the Act would further require the establish-\nment of expert panels to make classification recommendations\nto the Secretary of Health, Education, and Welfare (hereinafter\nreferred to as \"the Secretary\"). These classification panels\n978839\n2\nwould be organized according to the various fields of\nclinical medicine and fundamental sciences in which devices\nintended for human use would be used. After panel recommen-\ndations, the Secretary would provide an opportunity for\ncomment, and, thereafter, classify devices by regulation.\nThe Secretary would be authorized to change the classification\nof a device based upon new information and revoke any\nregulation or requirement in effect under new section 514\nor 515 of the Act with respect to the device.\nPerformance Standards\nSection 2 of the enrolled bill would also amend the Act\nby adding a new section 514, which would authorize the\nSecretary to establish, by regulation, a performance standard\nfor a class II device (including a device in class III,\nthe reclassification of which into class II is effective\nupon the effective date of a performance standard for it).\nSuch performance standards established for devices would\nprovide reasonable assurance of safe and effective performance;\nand, where necessary, would include provisions respecting:\n(1) the construction, components, ingredients, and properties of\nthe device and its compatibility with power systems; (2) the\ntesting of the device; (3) demonstration that the device is\nin conformity with portions of the standards for which tests\nwere required; (4) the measurement of the performance\ncharacteristics of the device; and (5) restrictions on\nthe distribution of a device. Performance standards\nwould, where appropriate, prescribe certain labeling\nfor a device.\nPremarket Approval\nSection 2 of the enrolled bill would amend the Act by adding\na new section 515, which would prescribe the authority and\nresponsibilities of the Secretary with respect to premarket\napproval of devices classified in class III.\n3\nA device, which had not been introduced or delivered for\nintroduction into interstate commerce before the date of\nenactment of this enrolled bill, and which had been classi-\nfied in class III, would be able to be marketed only after\nan application for premarket approval had been approved.\nA class III device which had been introduced or delivered\nfor introduction into interstate commerce before the date\nof enactment of this enrolled bill or was substantially\nequivalent to another device which had been so introduced\nor delivered for introduction into interstate commerce\nwould have to follow the application procedure only after\nthe Secretary had promulgated a regulation to require premarket\napproval pursuant to a notice and comment procedure set\nforth in this section.\nAny person would be authorized to file an application for\npremarket approval for a class III device and the Secretary\nwould be required to refer such application to the appropriate\nclassification panel under new section 513 of the Act for\nstudy and for submission of a report and recommendation\nrespecting approval of the application. Within 180 days\nfrom the receipt of the application, the Secretary would\napprove or deny approval of the application, unless the\nperiod were extended by agreement between the Secretary and\nthe applicant in cases in which the device had been introduced\nor delivered for introduction into interstate commerce before\nenactment of the enrolled bill or was substantially similar\nto another device which had been so introduced or delivered\nand the continued availability of the device was necessary\nfor the public health.\nThe Secretary, upon obtaining advice on scientific matters\nfrom a classification panel, after notice and opportunity\nfor an informal hearing, could issue an order withdrawing\napproval of an application for premarket approval.\nThe enrolled bill would authorize an alternative procedure\nfor gaining approval of an application for premarket approval\nof a class III device whereby, an appropriate product\ndevelopment protocol (PDP) was developed and approved by\nthe Secretary. A product development protocol would be\na procedure whereby the development of a product and the\n4\ndevelopment of data necessary to demonstrate safety and\neffectiveness would evolve simultaneously. Approval by\nthe Secretary of a notice of completion of a product\ndevelopment protocol would be the equivalent of approval\nof an application for premarket approval.\nBanned Devices\nSection 2 of the enrolled bill would amend the Act by adding\na new section 516, which would authorize the Secretary to\nban a device intended for human use which presented substantial\ndeception or an unreasonable and substantial risk of illness\nor injury.\nJudicial Review\nSection 2 of the enrolled bill would amend the Act by\nadding a new section 517, which would prescribe procedures\nfor judicial review of regulations and orders specified in\nthis section.\nNotification and Other Remedies\nSection 2 of the enrolled bill would amend the Act by adding\na new section 518, which would authorize the Secretary,\nupon his determination that a device intended for human use\npresents an unreasonable risk of substantial harm to the\npublic health, that notification is necessary to eliminate\nthe unreasonable risk, and that no other more practicable\nmeans are available to eliminate such risk, to issue an order\nrequiring notification of the risk to all health professionals\nwho prescribe or use the device and to any other person\n(including a device user) who should properly receive such\nnotification in order to eliminate the risk. If, after affording\nopportunity for an informal hearing, the Secretary determines\nthat notification by itself would not be sufficient to eliminate\nthe unreasonable risk of substantial harm, he could order the\nmanufacturer, importer, or distributor of the device to submit\na plan to repair, replace or refund the purchase price of the\ndevice.\nHowever, compliance with an order would not relieve persons\nfrom liability under Federal or State law, although any\nvalue received by a plaintiff as a result of such order\nwould be taken into account in awarding damages.\n5\nRecords and Reports on Devices Intended for Human Use\nSection 2 of the enrolled bill would amend the Act by adding\na new section 519, which would require manufacturers,\nimporters, and distributors of devices intended for human use\nto establish and maintain records, make reports and provide\ninformation required by regulations of the Secretary to assure\nthat devices were not adulterated or misbranded and to\notherwise assure their safety and effectiveness.\nGeneral Provisions Respecting Control of Devices Intended for\nHuman Use\nSection 2 of the enrolled bill would amend the Act by adding\na new section 520, which would establish general provisions\nrespecting control of devices intended for human use.\nCustom Devices\nThe enrolled bill would allow \"custom devices\" to deviate\nfrom performance standards and requirements for premarket\napproval in order to comply with an order of an individual\nphysician, dentist, or other specially qualified person if\n(1) the device was not generally available in finished\nform for purchase or dispensing upon prescription, and was\nnot offered through labeling or advertising by the manu-\nfacturer, importer, or distributor thereof for commercial\ndistribution, and (2) the device (a) was either intended\nfor use by an individual patient named in an order of\na physician or dentist (or other specially qualified person\nso designated) or intended solely to meet the special needs\nof such physician, dentist, or other specially qualified\nperson in the course of his practice, and (b) was not\ngenerally available to or generally used by other physicians,\ndentists, or other designated persons.\nRestricted Devices\nThe enrolled bill would authorize the Secretary to restrict\nthe sale, distribution, or use of a device if, because of\nits potentiality for harmful effect or as a result of the\ncollateral measures necessary to its use, the Secretary\ndetermines that there can not otherwise be reasonable assurance\n6\nof its safety and effectiveness. The label of such a device,\ncalled a \"restricted device\" would have to bear such appro-\npriate statements of restrictions as the Secretary may\nprescribe.\nGood Manufacturing Practice Requirements\nThe enrolled bill would authorize the Secretary to prescribe\nregulations requiring that the methods used in, and the\nfacilities and controls used for the manufacture, packing,\nstorage, and installation of devices conform to good\nmanufacturing practice in order to assure safety and\neffectiveness. Such regulations could be promulgated only\nafter opportunity for oral hearing and only after the opportunity\nto submit recommendations with respect to such proposed\nregulations had been afforded to a nine-person advisory\ncommittee established by the Secretary. Persons subject\nto good manufacturing practice requirements would be able\nto petition for exemptions or variances from such requirements.\nA petition for an exemption for a device could be approved\nif; the Secretary determined that compliance with the contested\nrequirement was not necessary to assure that the device\nwas safe, effective, and otherwise in compliance with the\nAct. Additionally, a petition for a variance for a device\ncould be approved if the Secretary determined that the\nproposed methods, facilities, and controls to be used\nwere sufficient to assure that the device was safe, effective,\nand otherwise in compliance with the Act.\nExemption for Devices for Investigational Use\nThe enrolled bill would authorize the Secretary to exempt\na device from the requirements of the Act if it was intended\nfor investigational use.\nRelease of Safety and Effectiveness Information\nThe enrolled bill would require the Secretary to promulgate\nregulations under which a detailed summary of information\nrespecting the safety and effectiveness of a device would\nbe made available to the public. Such information would be\nmade public upon approval, denial of approval, or withdrawal\n7\nof approval of an application for premarket approval; or upon\nthe revocation of an approved product development protocol\n(PDP), an order declaring a PDP completed or not completed,\nan order revoking the approval of a device approved under\nthe PDP procedure, or an order approving, disapproving, or\nwithdrawing approval of an application for exemption for\ninvestigational use of a device.\nProceedings of Advisory Panels and Committees\nThe enrolled bill would require each classification panel,\neach advisory committee established to review performance\nstandards, and each advisory committee established to review\nthe Secretary's action with respect to class III devices\nto make and maintain a transcript of any of its proceedings.\nConfidential information would be deleted.\nTraceability Requirements\nThe enrolled bill would require that no regulation could\nimpose requirements for the traceability of a type or class\nof device unless such requirements were necessary to assure\nthe protection of the public health.\nResearch and Development\nThe enrolled bill would authorize the Secretary to enter\ninto contracts for research, testing, and demonstrations\nrespecting devices and would authorize the Secretary to\nobtain devices for such purposes without regard to sections 3648\nand 3709 of the Revised Statutes (relating to advanced payment\nand procurement).\nTransitional Provision for Devices Considered as\nNew Drugs or Antibiotic Drugs\nThe enrolled bill would prescribe transitional provisions\nfor devices in various stages of regulation which had been\nclassified as new drugs or antibiotic drugs. Such devices\nwould be classified in class III unless the Secretary had\nclassified them into class I or class II pursuant to a\npetition filed by the manufacturer or importer of the device.\n8\nState and Local Requirements Respecting Devices Intended\nfor Human Use\nSection 2 of the enrolled bill would amend the Act by adding\na new section 521, which would preempt State and local\nrequirements for medical devices intended for human use\nthat differed from or were in addition to requirements\nestablished by the Secretary, although the Secretary could\nexempt a requirement of a State or locality from the\npreemption provision were the requirement more stringent\nthan the Federal requirement or were the requirement required\nby compelling local conditions and were a device which\ncomplied with the requirement not in violation of the Act.\nExport of Devices\nSection 3 (f) of the bill would amend section 801 (d) of the\nAct to prohibit the export of devices that did not comply\nwith the provisions of the Act unless they accorded to the\nspecifications of the foreign purchaser, were not in conflict\nwith the laws of the importing country, were labeled on\nthe outside of the shipping package as intended for export,\nand the health agency of the foreign country (or the Secretary\nif there were no such agency) would have to determine\nfor devices which did not comply with any applicable\nperformance standard, or premarket approval requirement, or\nwhich were exempt or banned that export was not contrary to\npublic health.\nRegistration of Manufacturers of Drugs and Listing of Drugs\nSection 4 of the enrolled bill would amend section 510 of\nthe Act (relating to registration of manufacturers of drugs\nand listing of drugs) to make the provision applicable to\ndevice manufacturers and to require that every establishment\nregistered under the provisions of section 510 which engaged\nin the manufacture, propagation, compounding, or processing\nof class II or class III devices be inspected at least once\nevery two years pursuant to section 704 of the Act.\n9\nOfficial Names\nSection 5 of the enrolled bill would amend section 502 (e)\nof the Act (relating to the use of established names for\ndrugs) and section 508 of the Act (which provides authority\nto designate official names for drugs) to make these sections\napplicable to devices.\nInspections Relating to Devices\nSection 6 of the enrolled bill would amend section 704 (a)\nof the Act (relating to inspections of establishments in\nwhich foods, drugs, devices or cosmetics were manufactured,\nprocessed, packed or held for introduction into interstate\ncommerce) to render provisions now applicable to establishments\nin which prescription drugs are manufactured applicable\nto establishments in which restricted devices are manufactured,\nto render the provisions with respect to access to research\ndata applicable to inspections with respect to restricted\ndevices, and would add a new section 704 (e) to assure access\nby officers or employees of the Secretary to records required\nto be maintained.\nAdministrative Restraint\nSection 7 of the enrolled bill would amend section 304 of the\nAct (relating to seizure of products in violation of the Act)\nto add a new provision (section 304 (g) authorizing temporary\nadministrative detention of devices)\nConfidential Information; Presumption of Interstate Commerce\nSection 8 of the enrolled bill would add two new sections,\n708 and 709 to the Act. New section 708 would authorize\nthe Secretary to provide trade secrets and other confidential\ninformation to persons under contract with the Secretary\nand only require security precautions as a condition to\nreceipt of such information. New section 709 would establish\na presumption of existence of connection with interstate\ncommerce required to establish jurisdiction in actions\nto enforce the Act with respect to devices.\n10\nColor Additives\nSection 9 of the enrolled bill would amend section 706 of\nthe Act (relating to color additives) to render a color\nadditive in a device subject to the provisions of that\nsection if the color additive came into contact with the\nbody of man or other animals for a significant period of time,\nand would authorize the Secretary to designate by regulation\nthe uses of color additives in or on devices which are\nsubject to section 706.\nAssistance for Small Device Manufacturers\nSection 10 of the enrolled bill would require the Secretary\nto establish, within the Department of Health, Education,\nand Welfare, an office to provide technical and other non-\nfinancial assistance to small manufacturers of devices to\nassist them in complying with requirements of the Act.\nIn this regard, the Secretary, in order to expedite\nimplementation of. this section, will publish a notice in\nthe Federal Register identifying an existing organizational\nentity within the Food and Drug Administration (FDA) to\ncarry out the responsibilities of this section. This notice\nwill provide the name, mailing address, and phone numbers of\nthe FDA unit which manufacturers can contact to obtain\ninformation to assist them in complying with the requirements\nof this Act. This unit will be a part of the office of FDA\nthat provides guidance to regulated industry in general. The\nunit will provide printed informational materials, respond\nto inquiries about statutory requirements, and conduct meetings,\nworkshops, and symposia designed to acquaint manufacturers\nwith their regulatory responsibilities under this legislation.\nMedical Devices Program\nResource Requirements with\nMedical Devices Legislation\n1977\n1977 with\n1976\nRequest\nSupplemental\n1978\n1979\n1980\n1981\nPos.\n6000\nPos.\n$200\nRom.\n4000\nFor.\n$000\nToo.\n8000\nPos.\n0000\nIna.\n8000\nClassification\n36\n1,036\n40\n1,208\n50\n2,790\n23\n2,040\n25\n2,040\n25\n2,040\n23\n2,040\nPre Market Approval\n-\n--\nA\n134\n84\n2,394\n194\n5,897\n209\n6,968\n209\n7,073\n209\n7,073\nRegulation\n3\n78\ns\n176\n13\n433\n10\n503\n18\n505\n18\n305\n18\n503\nRegistration\ns\n136\ne\n156\n21\n698\n31\n1,038\n31\n1,108\n31\n1,108\n313ᵗ\n1,105\nRecords and Reports\n4\n104\n4\n104\n14\n611\n19\n799\n24\n952\n23\n1,105\n29\n1,140\nStandards\n35\n1,310\n44\n1,831\n34\n2,435\nS4\n4,938\n119\n8,471\n144\n7,803\n144\n7,978\nRegulatory Operations\n43\n1,115\n43\n1,176\n97\n2,797\n97\n3,334\n167\n4,939\n167\n3,959\n187\n6,099\nResearch and Testing\n16\n782\n16\n963\nH\n1,812\n51\n3,609\n71\n4,908\n91\n6,018\n91\n6,153\nSurveillence/Spec. Invest.\n43\n1,118\n43\n1,110\n34\n1,343\n54\n1,620\n64\n1,653\n69\n2,043\n69\n2,078\nInspection\n95\n2,470\n100\n2,568\n300\n7,565\n440\n12,933\n700\n20,325\n750\n23,570\n750\n23,020\nTOTAL Program\n281\n9,222\n311\n9,364\n723\n23,060\n1,013\n35,733\n1,428\n50,131\n1,353\n37,224\n1,353\n58,049\nGERALD\nFORD\nLIBRARY\n5/19/76\nIncreases for Implementing\nMedical Device Lagislation A\n1977\n2977 Increase\nSupplemental\n2973 Increase\n1979 Increase\n1980 Increase\n1981 Incresse\nPos.\n$000\nFDS.\n4000\nPog.\n4000\nPco.\n$000\nPon.\n$000\nPOOR\n$000\nClassification\n4\n202\n10\n1,502\n-25\n-750\n-\n-\n-\n-\n-\n1\nPre Market Approval\n4\n134\nso\n2,260\n110\n3,503\n13\n1,071\n-\n103\n-\n-\nRegulation\n3\n98\n10\n259\n-\n70\n-\n-\n-\n-\n-\n-\nRegistration\n-\n-\n15\n542\n10\n340\n-\n70\n-\n-\n-\n-\nRecords and Reports\n-\n-\n10\n507\n5\n180\n3\n133\n3\n133\n-\n35\nStandards\nD\n571\n10\n554\n30\n2,503\n35\n1,533\n25\n1,332\n-\n173\nRegulatory Operations\n3\n30\n31\n1,621\n-\n537\n70\n2,645\n20\n950\n-\n140\nResearch and Testing\n-\n151\n13\n849\n20\n1,797\n20\n1,299\n20\n1,110\n-\n140\n--\nSurvaillence/Spec. Invest.\n-\n-\n11\n423\n-\n77\nID\n235\n5\n188\n-\n35\nInspections\ns\n98\n200\n4,997\n140\n5,370\n260\n7,390\n30\n3,245\n-\n350\nTOTAL Program\n30\n1,342\n422\n13,516\n290\n13,635\n435\n13,306\n123\n7,093\n-\n873\n. Excludes Buildings and Fecilities considerations.\nGERALD\nR.\nFORD\n5/19/76\nDRAFT MESSAGE FOR THE PRESIDENT\nToday, I have the pleasure of signing into law the Medical\nDevice Amendments of 1976 to the Federal Food, Drug, and\nCosmetic Act of 1938.\nIt is almost exactly 70 years since President Theodore Roosevelt\nsigned the nation's first federal food and drug legislation\ndesigned to protect the American consumer against health threats\narising from harmful substances and deceptive practices. In\nurging the passage of such legislation, he departed from his\npolicy of speaking softly, instead saying about as plainly and\nas forcefully as it can' be said, that: \"Traffic in foodstuffs\nwhich have been debased or adulterated so as to injure health\nor to deceive purchasers should be forbidden.\"\nSince the Pure Food and Drugs Act of 1906, there have been\na number of actions to strengthen and update the structure of\nprotection that President Roosevelt urged upon us.\nWhile we as a nation were able to take justifiable pride\nin the laws providing for safety, honesty and efficacy in the\nfoods and drugs we consume, it became increasingly clear that\nthere remained a large, significant and growing gap in that\nprotective wall.\nUntil today, the American consumer could not be sure that a\nmedical device used hv his physician his hospital\n2\nTheodore Roosevelt had no need to ask in 1906 for legislation\nconcerning medical devices. For the devices used by physicians\nof his day were comparatively simple. There was not much that\ncould go wrong with them. There were few ways they could be\nused incorrectly. They stood at the edge of medicine, helpful\nbut not essential, and, therefore, posed no regulatory need.\nBy the 1960's, however, enormous advances in science and\ntechnology moved medical devices from the edge close to the center\nof the stage. Today devices are routinely implanted in our bodies.\nThey replace limbs, bones, tissues, even entire organs. They\npermit treatment of forms of illness that can be reached in no\nother way. They magnify and speed ten thousandfold the diagnostic\npower of the human eye and brain.\nMedical and diagnostic devices have produced what can\nonly be called a therapeutic revolution. In doing so, they\nhave also become more complex and less easily understood by those\nwho use them. When well designed, well made, and properly used\nthey support and lengthen life. If poorly designed, poorly\nmade, and improperly used they can threaten and impair it.\nDespite the increasing importance of devices, the Food and\nDrug Administration has had woefully inadequate authority to\ndeal with them. FDA has had no reliable way of knowing how many\ndevices there are, who is making them, who is selling them, what\ninjuries they can cause, and when a manufacturer has found it\nnecessary to remove them from the medical marketplace.\nIn addition, no device was required to be proven safe\nand effective prior to marketing, no matter how critical it\nmight be to the person using it, and even if that use involved\nimplantation in his body.\nRecognizing these and other deficiencies, the Administration\nordered a study of the problem in 1969 and subsequently asked\nCongress to enact remedial legislation.\nIn its deliberations since that time, Congress benefited\ngreatly from the cooperation voluntarily extended by the\nmedical device industry which clearly saw the need for legislation\nthat would protect the consumer as well as the manufacturer who\nrefused to compromise with safety. Representatives of consumers\nand health professionals also played an important role.\nThe Medical Device Amendments of 1976 eliminate the\ndeficiencies that accorded FDA \"horse and buggy\" authority to\ndeal with \"laser age\" problems. It is important not only in\nwhat it will do to protect the consumer; it is also important\nas a symbol for the kind of regulation that I feel is most\nappropriate to government. For this law, while it does expand\nthe regulatory authority of an agency of the Federal government --\nThe Food and Drug Administration -- it does not -- as so much\nregulation has -- impinge our freedom or unduly restrict\nenterprise.\nIt does not represent another expansion of government\ninto affairs we might better manage ourselves. Instead, this\nis an example of government doing for the individual citizen\nwhat he or she cannot do unaided.\n4\nIt is not government expanding because the opportunity is\nthere; it is government responding to a need by adding a vital\nprotection to the public health.\nIt is not government that impairs the competitive nature\nof a dynamic new industry; this is government that strengthens\nour competitive posture in the world by insuring medical\nproducts of quality, safety and efficacy.\nThis is government action that does not further complicate\nthe task of professionals affected by it, but rather frees them\nby permitting concentration on the patient rather than on the\npossible unreliability of the tools used to treat the patient.\nFinally, this is government that is not preventing the\nfull, productive exercise of the compassionate ingenuity that\nhas fueled this society for 200 years: this is an example of\ngovernment preventing threats to the public health in a way\nthat is fully consonant with the principles of competitive\neconomic development on which this nation was built.\nThese then are the reasons why I welcome this legislation\nand applaud all who devised, and those who will enforce, it.\nThis legislation is a superlative example of the system working\nthe way those who founded this nation 200 years ago expected it\nto work.\nREVOLUTION\nVETERANS ADMINISTRATION\nOFFICE OF THE ADMINISTRATOR OF VETERANS AFFAIRS\nAMERICAN\nBICENTENNIAL\nWASHINGTON, D.C. 20420\n1776-1976\n(\nMay 20, 1976\nThe Honorable\nJames T. Lynn\nDirector, Office of\nManagement and Budget\nWashington, D. C. 20503\nDear Mr. Lynn:\nThis will respond to the request of the Assistant\nDirector for Legislative Reference for the views of the Vet-\nerans Administration on the enrolled enactment of S. 510,\n94th Congress, \"To amend the Federal Food, Drug, and Cosmetic\nAct to provide for the safety and effectiveness of medical\ndevices intended for human use, and for other purposes.\"\nThe measure provides for classification of all med-\nical devices intended for human use into one of three cate-\ngories based on the extent of regulation necessary to assure\nsafety and effectiveness.\nThe enrolled bill sets classifications ranging from\na category of devices subject to general controls, to a\nsecond group that must meet performance standards, to a third\nclassification under which devices are subject to premarket\napproval. That third class represents devices that cannot\nbe set into the less rigorously regulated classes because\ninsufficient information exists with which to determine the\nadequacy of general controls or standards to provide reason-\nable assurance of safety and effectiveness; also these are\ndevices which are purported or represented to be for a use\nin supporting or sustaining life or for a use of substantial\nimportance in preventing impairment of health or which\npresent a potential unreasonable risk of illness or injury.\nUnder the legislation, panels composed of experts\nappointed by the Secretary of Health, Education, and Welfare\nwould submit recommendations regarding proper classification\nof \"old,\" already introduced devices; thereafter the Secre-\ntary would promulgate a regulation classifying the devices.\nNewly introduced devices, not substantially equivalent to\nexisting ones, would automatically fall within the third\nclass until reclassified by the Secretary. In regard to\nthe provisions governing the general requirement as to\nclass III devices of applying for premarket approval, there\nis set a 180-day limit for action thereon by the Secretary.\nWith respect to the development and establishment\nof performance standards for so-called class II devices,\nthe Secretary could accept offers by any person to develop\nsuch standards, could adopt an existing performance stand-\nard, or could authorize a Federal agency to develop such\na standard. As to the Secretary's mandate to provide for\nperiodic evaluation of these standards, we note the language\nof section 514 (a) (5) (A) of the enrolled bill authorizing\nthat official to \"use personnel, facilities, and other\ntechnical support available in other Federal agencies.\"\nPersons adversely affected by a proposed standard could\nrequire its submission to an advisory committee of experts.\nAmong the many other significant provisions of\nthe enrolled bill are measures requiring notification of\npatients subject to risks or hazards presented by devices;\nprovision for restricting the sale, distribution, or use\nof devices; and authorization for establishment of require-\nments for good manufacturing practice.\nThe Veterans Administration, in the administration\nof far-flung medical activities, is, of course, vitally\ninterested in the protection of public health and safety.\nWe applaud the purposes of this legislation and are particu-\nlarly concerned with the need to protect the consumer of\nmedical services from unsafe and ineffective medical devices.\nGERALD\nThe number and diversity of devices used in diagno-\nsis, monitoring and treatment of patients in modern clinical\npractice grows increasingly significant. Moreover, there\nhas been an increase in the number of firms engaged in the\nmanufacture and sale of these devices. Their products may\nvary substantially with regard to effectiveness of perform-\nance and margin of safety.\nThe VA has for many years regulated the quality,\nsafety, and performance of prosthetic devices for amputees,\nand has established performance standards for these and\nother devices. We believe this program has been eminently\nsuccessful and welcome an extension of its benefits to all\nmedical devices.\nThe major features of the bill--classification, use\nof performance standards, good manufacturing practices,\nand reliance upon panels and advisory committees--have\nattained general acceptance after years of debate. The bill\nis a well conceived, thoroughly detailed document. We favor\nthe provisions of the enrolled bill. Therefore, I recommend\nthat the President approve S. 510.\nSincerely,\nDeputy Administrator . in the absence of\nRICHARD L. ROUDEBUSH\nAdministrator\n3.\nDEPARTMENT or COMMARCE\nGENERAL COUNSEL OF THE\nUNITED STATES DEPARTMENT OF COMMERCE\nUNITED\nAMERICA\nWashington, D.C. 20230\nSTATES\nof\nMAY 18 1976\nHonorable James T. Lynn\nDirector, Office of Management\nand Budget\nWashington, D. C. 20503\nAttention: Assistant Director for Legislative Reference\nDear Mr. Lynn:\nThis is in reply to your request for the views of this Department\nconcerning S. 510, an enrolled enactment\n\"To amend the Federal Food, Drug, and Cosmetic Act\nto provide for the safety and effectiveness of medical\ndevices intended for human use, and for other purposes, 11\nto be cited as the \"Medical Device Amendments of 1976. 11\nThe purpose of S. 510 is to provide new authority to the Secretary\nof Health, Education, and Welfare to assure the safety and effective-\nness of medical devices intended for human use. It would require\npremarket approval of certain medical devices and authorize estab-\nlishment of performance standards for others. Also, it would\nstrengthen the authority of the Food and Drug Administration to\ntake regulatory action against hazardous or deceptive medical\ndevices, to prescribe good manufacturing practice regulations, to\ninspect records, to register device manufacturers, and to require\nmaintenance of records and submission of reports concerning these\nproducts.\nThis Department would have no objection to approval by the President\nof S. 510.\nEnactment of this legislation will not involve any increase in the\nbudgetary requirements of this Department.\nSincerely,\n7.F.dmith General Counsel\nREVOLUTION\nAMERICAN\nBICENTENNIAL\nSIST/NT ATTORNEY GENERAL\nATIVE AFFAIRS\nDepartment of Justice\nMashington, D.C. 20530\nMay 20, 1976\nHonorable James T. Lynn\nDirector\nOffice of Management and Budget\nWashington, D.C. 20503\nDear Mr. Lynn:\nIn compliance with your request, I have examined\na facsimile of the enrolled bill S. 510 \"To amend\nthe Federal Food, Drug and Cosmetic Act to provide\nfor the safety and effectiveness of medical devices\nintended for human use, and other purposes.\"\nThe enrolled bill, otherwise known as \"The\nMedical Device Amendments of 1976, is the culmination\nof several years work by Congress, the Food and Drug\nAdministration, other Executive Departments, industry\nand consumer groups. In short S. 510 establishes\nclassifications for devices intended for human use,\nand sets out the standards for both safety and efficacy\nof medical devices. At present, there is no relevant\nfederal law on the regulation of most devices except\nto the extent the government has been able to argue\nsuccessfully that a particular item is a drug and thus\nwithin the present Food, Drug and Cosmetic Act.\nSection 515 of the enrolled bill provides, with\ncertain \"grandfather\" provisions (section 520(1))\nthat medical devices must prior to their introduction\ninto interstate commerce receive premarket approval\nfrom the Food and Drug Administration. Devices not\nreceiving approval would be banned by virtue of section\n516 and the enforcement sanctions of the present Food,\nDrug and Cosmetic Act would be applicable, see 21 U.S.C.\n331, 333.\nJudicial review would be available under section\n517 to anyone seeking reversal of agency action regarding\na medical device to which the person has an interest.\nThe enrolled bill appears to effectively solve\nmany problems previously associated with medical devices,\nthe safety and efficacy of which have been outside the\nscope of the Food and Drug Administration's responsibility.\nThe Department of Justice has no objection to Execu-\ntive approval of this bill.\nSincerely,\nmichael In Uhiman\nMichael M. Uhlmann\nAssistant Attorney General\nDEPARTMENT OF THE ARMY\nWASHINGTON, D.C. 20310\nTHE\n21 May 1976\nHonorable James T. Lynn\nDirector, Office of Management and Budget\nDear Mr. Lynn:\nThe Secretary of Defense has delegated responsibility to the Department\nof the Army for reporting the views of the Department of Defense on\nenrolled enactment S.510, 94th Congress, \"To protect the public health\nby amending the Federal Food, Drug, and Cosmetic Act to assure the\nsafety and effectiveness of medical devices. \"\nThe Department of the Army on behalf of the Department of Defense sup-\nports the objectives of the enrolled enactment but defers to the views\nof the Department of Health, Education and Welfare as to its merits.\nThe purpose of the act is stated in its title.\nApproval of the enactment may have a minor impact on that portion of the\nDOD budget used to fund medical programs; however, no funds have been\nincluded in the budget for this item.\nThis report has been coordinated within the Department of Defense in\naccordance with procedures prescribed by the Secretary of Defense.\nSincerely,\nMartin R offmann\nSecretary OF the Army\nTHE WHITE HOUSE\nWASHINGTON\nMay 21, 1976\nMEMORANDUM FOR:\nJIM CAVANAUGH\nsel\nFROM:\nSPENCE JOHNSON\nSUBJECT:\nSchedule Proposal: S. 510,\nMedical Devices Act of 1976.\nAttached is the schedule proposal per our conversation.\nSince the President is not returning to the White House\nuntil Thursday, Bill Nicholson has indicated there may\nbe some problem in getting this on his schedule. There-\nfore, it may require some extra push.\nThanks.\nTHE WHITE HOUSE SCHEDULE PROPOSAL\nWASHINGTON\nDATE: May 21, 1976\nFROM:\nSpencer Johnson\nTHRU:\nJim Cannon\nVIA:\nBill Nicholson\nMEETING:\nSigning Ceremony\nDATE:\nThursday, May 27, 1976\nPURPOSE:\nTo sign S. 510, Medical Devices Act of 1976.\nFORMAT:\nRose Garden or Cabinet Room\n10 minutes\nParticipants: Secretary David Mathews and\nselected HEW staff; Members of Congress and\nselected committee staff; industry repre-\nsentatives.\nSPEECH\nMATERIAL:\nTalking points to be provided by the Domestic\nCouncil.\nPRESS\nCOVERAGE:\nFull coverage; press and photo opportunity.\nSTAFF:\nJim Cannon, Spencer Johnson.\nRECOMMEND:\nDomestic Council, Department of HEW, OMB.\nBACKGROUND:\nS. 510 amends the Food, Drug and Cosmetic\nAct of 1962 to permit the Secretary of HEW\nto protect the public from unsafe or in-\neffective medical devices. The tremendous\nmedical technological explosion has resulted\nin unknown numbers of medical devices used\nin the practice of medicine for which there\nis no effective means to insure safety and\neffectiveness. The legislation, the first\nsignificant amendment to the Food, Drug\nand Cosmetic Act of 1962, grants the Food\nand Drug Administration the authority to\nrespond to this vital need to protect the\npublic health. The measure frees professionals\nto concentrate solely on the patient in pro-\nviding high quality medical care, rather than\nconcerning themselves with the possible un-\nreliability of the tools at their disposal.\nAPPROVE\nDISAPPROVE\nTHE WHITE HOUSE\nWASHINGTON\nSIGNING CEREMONY\nMEDICAL DEVICE AMENDMENTS OF 1976\n(Enrolled Bill S. 510)\nFriday, May 28, 1976\n12:00 p.m. (10 minutes)\nThe Oval Office\nFrom: Jim Cannon\nI. PURPOSE\nTo sign into law Enrolled Bill S. 510, Medical\nDevice Amendments of 1976 which provides new\nauthority to the Secretary of Health, Education,\nand Welfare to assure the safety and effective-\nness of medical devices intended for human use.\nII. BACKGROUND, PARTICIPANTS, PRESS PLAN\nA. Background: S. 510 would amend the Federal\nFood, Drug and Cosmetic (FDC) Act of 1938\nto provide the Food and Drug Administration\n(FDA) in the Department of Health, Education\nand Welfare (HEW) with significant new\nauthority to regulate the safety and effective-\nness of medical devices. The enrolled bill\nis the first amendment to the FDC Act since\n1938 dealing with medical devices and repre-\nsents several years of work by the Executive\nbranch and the Congress to develop acceptable\nlegislation to assure that modern medical\ndevices are safe and effective.\nB. Participants:\nSecretary David Mathews\nDr. Theodore Cooper, Assistant Secretary of Health\nDr. Alexander Schmidt, Commissioner, FDA\nSylvester Jones, Intern for Secretary Mathews\n- 2 -\nC. Press Plan: No announcement. White House\nphoto opportunity.\nIII. TALKING POINTS\n1. I am pleased to sign into law the Medical\nDevice Amendments of 1976 which will give\nthe Secretary of Health, Education and Welfare\nnew authority to assure safe and effective\nmedical devices for America's medical system.\n2. These amendments will give the Food and Drug\nAdministration the ability to do for the\nindividual citizen what he or she cannot do\nfor themselves -- prevent the sale or use of\nunsafe or ineffective medical devices.\n3. The FDA faces a most difficult task that\nrequires determination, scientific skills,\njudgement, and most of all, compassion for\nthe hopes and needs of our fellow man.\n4. I commend the Congress, HEW, and the FDA\nfor their fine work and cooperation.\nFOR IMMEDIATE RELEASE\nMAY 28, 1976\nOffice of the White House Press Secretary\nTHE WHITE HOUSE\nSTATEMENT BY THE PRESIDENT\nToday I have the pleasure of signing into law S. 510,\nthe Medical Device Amendments of 1976 to the Federal Food\nDrug, and Cosmetic Act of 1938.\nIt is almost exactly 70 years since President Theodore\nRoosevelt signed the Pure Food and Drugs Act of 1906, the\nnation's first federal food and drug legislation designed\nto protect the American consumer against health threats\narising from harmful substances and deceptive practices.\nSince then, there have been a number of actions to\nstrengthen and update the structure of protection sought\nby President Roosevelt.\nWhile we as a nation were able to take justifiable\npride in the laws providing for safety, honesty and\nefficacy in the foods and drugs we consume, it became\nincreasingly clear that there remained a large, significant\nand growing gap in that security.\nUntil today, the American consumer could not be sure\nthat a medical device used by his physician, his hospital,\nor himself was as safe and effective as it could or should\nbe.\nIn 1906, President Roosevelt had no need to ask for\nlegislation concerning medical devices: for the devices\nused by physicians of his day were comparatively simple.\nThey stood at the edge of medicine, helpful but not essential.\nand, therefore, posed no regulatory need.\nBy the 1960's, however, enormous advances in science\nand technology moved medical devices from the edge close\nto the center of the stage. Today devices are routinely\nimplanted in our bodies. They replace limbs, bones,\ntissues even entire organs. They permit treatment of\nforms of illness that can be accomplished in no other way.\nThey magnify and speed ten thousandfold the diagnostic\npower of the human eye and brain.\nMedical and diagnostic devices have produced a thera-\npeutic revolution, but in doing so, they have also become\nmore complex and less easily understood by those who use\nthem. When well designed, well made, and properly used\nthey support and lengthen life. If poorly designed, poorly\nmade, and improperly used they can threaten and impair it.\nDespite the increasing importance of devices, the Food\nand Drug Administration has had inadequate authority to deal\nwith them. FDA has had no reliable way of knowing how many\ndevices there are, who is making them, who is selling them\nwhat risks to health and life they may present, and when a\nmanufacturer has found it necessary to remove them from\nthe medical marketplace.\nmore\n2\nIn addition, no device was required to be proven safe\nand effective prior to marketing. no matter how crucial it\nmight be to the person using it, even if that use involved\nimplantation in his body.\nRecognizing these and other deficiencies the\nAdministration ordered a study of the problem in 1969\nand subsequently asked Congress to enact remedial legislation.\nIn its deliberations since that time, Congress benefited\ngreatly from the cooperation voluntarily extended by the\nmedical device industry who clearly saw the need for legis.\nlation that would protect the consumer as well as the\nmanufacturer who refused to compromise with safety.\nRepresentatives of consumers and health professionals also\nplayed an important role.\nThe Medical Device Amendments of 1976 eliminate the\ndeficiencies that accorded FDA \"horse and buggy authority\nto deal with Plaser age\" problems. It is important not\nonly in what it will do to protect the consumer it is also\nimportant as a symbol for the kind of regulation that I feel\nis most appropriate to government. It does not represent\nanother expansion of government into affairs we might better\nmanage ourselves. Instead, this is an example of government\ndoing for the individual citizen what he or she cannot do\nunaided.\nI welcome this legislation and commend the FDA who\nidentified the need, cooperated in its development, and\nfinally, will be entrusted with its enforcement.\nThis agency daily faces a most difficult task\npreventing threats to the public health in a way that is\nnot onerous, but fully consonant with the principles of\ncompetitive economic development on which this nation was\nbuilt. It is a task that requires determination, scientific\nskill, judgment and most of all, compassion for the hopes\nand needs of our fellow man. Dr. Alexander M. Schmidt,\nCommissioner of Food and Drugs. has effectively taken\non the job of assuring that the hope and expectations\nof the consumer for life-giving drugs and devices are not\nfalse promises.\nI reaffirm my support for the fine work of the Food\nand Drug Administration and the job ahead.\n#\n#\n#\nFOR IMMEDIATE RELEASE\nMAY 28, 1976\nOffice of the White House Press Secretary\nTHE WHITE HOUSE\nSTATEMENT BY THE PRESIDENT\nToday, I have the pleasure of signing into law S. 510,\nthe Medical Device Amendments of 1976 to the Federal Food\nDrug, and Cosmetic Act of 1938.\nIt is almost exactly 70 years since President Theodore\nRoosevelt signed the Pure Food and Drugs Act of 1906, the\nnation's first federal food and drug legislation designed\nto protect the American consumer against health threats\narising from harmful substances and deceptive practices.\nSince then, there have been a number of actions to\nstrengthen and update the structure of protection sought\nby President Roosevelt.\nWhile we as a nation were able to take justifiable\npride in the laws providing for safety, honesty and\nefficacy in the foods and drugs we consume, it became\nincreasingly clear that there remained a large, significant\nand growing gap in that security.\nUntil today, the American consumer could not be sure\nthat a medical device used by his physician, his hospital,\nor himself was as safe and effective as it could or should\nbe.\nIn 1906, President Roosevelt had no need to ask for\nlegislation concerning medical devices; for the devices\nused by physicians of his day were comparatively simple.\nThey stood at the edge of medicine, helpful but not essential.\nand, therefore, posed no regulatory need.\nBy the 1960's, however, enormous advances in science\nand technology moved medical devices from the edge close\nto the center of the stage. Today devices are routinely\nimplanted in our bodies. They replace limbs, bones,\ntissues even entire organs. They permit treatment of\nforms of illness that can be accomplished in no other way.\nThey magnify and speed ten thousandfold the diagnostic\npower of the human eye and brain.\nMedical and diagnostic devices have produced a thera-\npeutic revolution, but in doing so, they have also become\nmore complex and less easily understood by those who use\nthem. When well designed, well made, and properly used\nthey support and lengthen life. If poorly designed, poorly\nmade, and improperly used they can threaten and impair it.\nDespite the increasing importance of devices, the Food\nand Drug Administration has had inadequate authority to deal\nwith them. FDA has had no reliable way of knowing how many\ndevices there are, who is making them, who is selling them\nwhat risks to health and life they may present, and when a\nmanufacturer has found it necessary to remove them from\nthe medical marketplace.\nmore\n2\nIn addition, no device was required to be proven safe\nand effective prior to marketing, no matter how crucial it\nmight be to the person using it, even if that use involved\nimplantation in his body.\nRecognizing these and other deficiencies the\nAdministration ordered a study of the problem in 1969\nand subsequently asked Congress to enact remedial legislation.\nIn its deliberations since that time, Congress benefited\ngreatly from the cooperation voluntarily extended by the\nmedical device industry who clearly saw the need for legis\nlation that would protect the consumer as well as the\nmanufacturer who refused to compromise with safety.\nRepresentatives of consumers and health professionals also\nplayed an important role.\nThe Medical Device Amendments of 1976 eliminate the\ndeficiencies that accorded FDA \"horse and buggy\" authority\nto deal with laser age' problems. It is important not\nonly in what it will do to protect the consumer it is also\nimportant as a symbol for the kind of regulation that I feel\nis most appropriate to government. It does not represent\nanother expansion of government into affairs we might better\nmanage ourselves. Instead, this is an example of government\ndoing for the individual citizen what he or she cannot do\nunaided.\nI welcome this legislation and commend the FDA who\nidentified the need cooperated in its development, and\nfinally will be entrusted with its enforcement.\nThis agency daily faces a most difficult task\npreventing threats to the public health in a way that is\nnot onerous, but fully consonant with the principles of\ncompetitive economic development on which this nation was\nbuilt. It is a task that requires determination, scientific\nskill, judgment and most of all, compassion for the hopes\nand needs of our fellow man. Dr. Alexander M. Schmidt,\nCommissioner of Food and Drugs, has effectively taken\non the job of assuring that the hope and expectations\nof the consumer for giving drugs and devices are not\nfalse promises.\nI reaffirm my support for the fine work of the Food\nand Drug Administration and the job ahead.\n#\n#\n#\nJune 9, 1976\nDear Miss Glisson:\nAs you know, I signed S. 510, the\nMedical Device Amendments of 1976, on\nMay 28. Because of your efforts on\nbehalf of this legislation, I am\npleased to send you a ceremonial pen\nto mark the bill becoming Public Law\n94-295.\nSincerely,\nMiss Johnne Glisson\nResearch Assistant\nSubcommittee on Health\nand the Environment\nCommittee on Interstate\nand Foreign Commerce\nHouse of Representatives\nWashington, D. C. 20515\nCC: Spencer Johnson -FYI\nGRF:MLF:JEB:VO:emu\nFORD & LIBRARY GERALD\nJune 9, 1976\nDear Mr. Greene:\nAs you know, I signed S. 510, the\nMedical Device Amendments of 1976, on\nMay 28. Because of your efforts on\nbehalf of this legislation, I am\npleased to send you a ceremonial pen\nto mark the bill becoming Public Law\n94-295.\nSincerely,\nMr. H. Thomas Greene\nAssociate Counsel\nCommittee on Interstate\nand Foreign Commerce\nHouse of Representatives\nWashington, D. C. 20515\nCC: Spencer Johnson - FYI\nGRF:MLF:JEB:VO:emu\nFORD LIBRARY i GERALD\nJune 9, 1976\nDear Mr. Meade:\nAs you know, I signed S. 510, the\nMedical Device Amendments of 1976, on\nMay 28. Because of your efforts on\nbehalf of this legislation, I am\npleased to send you a ceremonial pen\nto mark the bill becoming Public Law\n94-295.\nSincerely,\nMr. David E. Meade\nAssistant Counsel\nOffice of the Legislative Counsel\nHouse of Representatives\nWashington, D. c. 20515\ncc: Spencer Johnson, FYI\nGRF:MLF:JEB:VO:emu\nFORD LIBRARY & GERALD\nJune 9, 1976\nDear Mr. Lawton:\nAs you know, I signed S. 510, the\nMedical Device Amendments of 1976, on\nMay 28, Because of your efforts on\nbehalf of this legislation, I am\npleased to send you a ceremonial pen\nto mark the bill becoming Public Law\n94-295.\nSincerely,\nMr. Stephan Lawton\nCounsel\nSubcommittee on Health\nand the Environment\nCommittee on Interstate\nand Foreign Commerce\nHouse of Representatives\nWashington, D. C. 20515\nCC: Spencer Johnson - FYI\nGRF:MLF:JEB:VO:emu\nFORD LIBRARY Y GERALD\nJune 9, 1976\nDear Dick:\nAs you know, I have signed S. 510, the\nMedical Device Amendments of 1976. Be-\ncause of your special interest in this\nlegislation, I am pleased to send you\na ceremonial pen to mark the bill\nbecoming Public Law 94-295 on May 28.\nSincerely,\nThe Honorable Richard S. Schweiker\nUnited States Senate\nWashington, D. c. 20510\nCC: Spencer Johnson, FYI\nGRF:MLF:JEB:VO:emu\nGERALD\nFORD LIBRARI j\nJune 9, 1976\nDear Ted:\nAs you know, I have signed S. 510, the\nMedical Device Amendments of 1976. Be-\ncause of your special interest in this\nlegislation, I am pleased to send you\na ceremonial pen to mark the bill\nbecoming Public Law 94-295 on May 28.\nSincerely,\nThe Honorable Edward H. Kennedy\nUnited States Senate\nWashington, D. C. 20510\nCC: Spencer Johnson, FYI\nGRF:MLF:JEB:VO:emu\nFORD LIBRARY is GERALD\nJune 9, 1976\nDear Tim:\nAs you know, I have signed S. 510, the\nMedical Device Amendments of 1976. Be-\ncause of your special interest in this\nlegislation, I am pleased to send you\na ceremonial pen to mark the bill\nbecoming Public Law 94-295 on May 28.\nSincerely,\nThe Honorable Tim Lee Carter\nHouse of Representatives\nWashington, D. C. 20515\nCC: Spencer Johnson, FYI\nGRF:MLF:JEB:VO:emu\nFORD LIBRARY is CERALD\nJune 9, 1976\nDear Paul:\nAs you know, I have signed S. 510, the\nMedical Device Amendments of 1976. Be-\ncause of your special interest in this\nlegislation, I am pleased to send you\na ceremonial pen to mark the bill\nbecoming Public Law 94-295 on May 28.\nSincerely,\nThe Honorable Paul G. Rogers\nHouse of Representatives\nWashington, D. c. 20515\ncc: Spencer Johnson, FYI\nGRF:MLF:JEB:VO:emu\nFORD\nGERALD R. LIBRARY\nHEALTH.\nOF\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nOFFICE OF THE SECRETARY\nU.S.A\nWASHINGTON, D.C. 20201\nJune 23, 1976\nMr. Spencer C. Johnson\nAssociate Director for Health,\nSocial Security, and Welfare\nThe Domestic Council\nWashington, D. C. 20501\nDear Mr. Johnson:\nThank you for sending me a copy of the photograph taken at\nthe signing of the Medical Device Amendments of 1976 at the\nWhite House. Dr. Mathews was very accurate in saying that\nI am \"delighted\" to have a copy of the photograph with\nPresident Ford signing the Amendments.\nI can assure you that it was a great pleasure to meet\nPresident Ford. It was an event that will always be remem-\nbered as a highlight of my summer in Washington, D. C. with\nthe Department of Health, Education, and Welfare.\nSincerely,\nSylvester Jones\nStudent Assistant\nCC: Secretary Mathews\nHEALTH. EDUCATION\nTHE SECRETARY OF HEALTH, EDUCATION, AND WELFARE\nDEPAR ONV OF\nWASHINGTON, D. C. 20201\nU.S.A.\nThe Honorable Spencer C. Johnson\nAssociate Director\nThe Domestic Council\nWashington, D.C. 20500\nDear Spence:\nThank you for sending me copies of the photo-\ngraph taken at the signing of the Medical Device\nAmendments of 1976. Sylvester Jones is delighted\nto have a copy also.\nCC: Mr. Sylvester Jones\nSpencer Johnson\nJune 25, 1976\nDear Bill:\nThis is in further reply to your May 27\nletter to the President concerning the\nMedical Device Amendments and the possible\neffect of this legislation on ophthalmole-\ngists in your Districe.\nI understand you have written a apparate\nletter on this matter to Commissioner\nSchmidt of the Food and Drug Administra-\ntion, and that he is preparing a detailed\nreply which you should receive shortly.\nI hope the information he will furnish\nwill be helpful to you. If you have\nadditional questions, please let ne know.\nwith kindest regards,\nSincerely,\nCharles Leppart, Jr.\nDeputy Assistant\nto the President\nThe Nonorable William N. Ketchum\nHouse of Representatives\nWashington, D.C. 20515\nbee: James Cannon (atta; Spencer Johnson) --- FYI\nCL:HEW:DOM.COUNCIL:JEB:jem\nFORD LIBRARY & GERALD\nHEALTH.\nOF\nAPPLICA\nDEPARTMENT OF HEALTH, EDUCATION, AND WELFARE\nOFFICE OF THE SECRETARY\nU.S.A.\nWASHINGTON, D.C. 20201\n1 2 JUL 1976\nTO:\nSpencer Johnson\nFROM: Gene Haislip\nSUBJECT: Recognition for Major Contribution to the Enactment\nof Medical Devices Legislation\nAttached is a list of persons whose efforts were in large\nmeasure responsible for the passage of P.L. 94-295, a major\npiece of legislation establishing necessary controls over\nthe marketing of medical devices. The list was prepared at\nmy request by FDA with the instruction that only those persons\nwho had played a leading role were to be included. I suggest\nthat each of them receive a Presidential pen and suitable\nexpression of appreciation for their contribution to the\nenactment of this law.\nGene\nLIST OF INDIVIDUALS TO RECEIVE PENS USED\nIN SIGNING THE MEDICAL DEVICE BILL INTO LAW\nMembers of Congress\nJacob K. Javits, Ranking Minority Member\nCommittee on Labor and Public Welfare\nUnited States Senate\nEdward M. Kennedy, Chairman\nSubcommittee on Health\nCommittee on Labor and Public Welfare\nUnited States Senate\nPaul G. Rogers, Chairman\nSubcommittee on Health and the Environment\nCommittee on Interstate and Foreign Commerce\nHouse of Representatives\nTim Lee Carter, Ranking Minority Member\nSubcommittee on Health and the Environment\nCommittee on Interstate and Foreign Commerce\nHouse of Representatives\nDepartment of Health, Education, and Welfare\nTheodore Cooper, M.D., Assistant Secretary for Health\nCongressional Staff Members\nStephan E. Lawton, Counsel\nSubcommittee on Health and the Environment\nCommittee on Interstate and Foreign Commerce\nHouse of Representatives\nH. Thomas Greene, Associate Counsel\nMinority Staff\nCommittee on Interstate and Foreign Commerce\nHouse of Representatives\nLowrence Horowitz, M.D.\nProfessional Staff Member\nSubcommittee on Health\nCommittee on Labor and Public Welfare\nUnited States Senate\nPORD LIBRARY & GERALD\n- 2 -\nCongressional Staff Members (Continued)\nJay Cutler, Minority Counsel\nSubcommittee on Health\nCommittee on Labor and Public Welfare\nUnited States Senate\nAlan Fox, Staff Assistant\nSubcommittee on Health\nCommittee on Labor and Public Welfare\nUnited States Senate\nFood and Drug Administration Staff Members\nRichard A. Merrill, Chief Counsel\nLinda Horton, Associate Chief Counsel for\nMedical Devices and Diagnostic Products\nDavid R. Link, Director, Bureau of Medical\nDevices and Diagnostic Products\n*One for the Food and Drug Administration\nFORD LIBRARY is GERALD\nmedical deview\nNOTICES\n28817\nNational Bureau of Standards\nDrug and Cosmetic Act (21 U.S.C. 360j)\n4. Two of the members shall be repre-\nFEDERAL INFORMATION PROCESSING\nsubmissions by September 13, 1976.\nsentative of the interests of the general\nSTANDARDS TASK GROUP 13 WORK-\nSince December 1973, FDA has been\npublic.\nLOAD DEFINITION AND BENCHMARK-\ninvolved in the development of current\nTo be considered for appointment to\nING\ngood manufacturing practice regulations\nthis advisory committee, each nomination\nMeeting\nfor medical devices. A preliminary draft\nmust be received on or before September\nof a proposed current good manufactur-\n13, 1976 and must be accompanied by a\nPursuant to the Federal Advisory Com-\ning practice regulation was made avail-\ncurriculum vitae that includes the\nmittee Act, 5 U.S.C. App. I (Supp. IV,\nable to the public by notice of availabil-\nnominee's current employment, profes-\n1974), notice is hereby given that the\nity published in the FEDERAL REGISTER'Of\nsional affiliations, and educational and\nFederal Information Processing Stand-\nAugust 8, 1975 (40 FR 33482). A subse-\nexperience background, if any, with re-\nards Task Group 13 (FIPS TG-13),\nquent notice published in the FEDERAL\nspect to medical devices. Additionally,\nWorkload Definition and Benchmark-\nREGISTER of October 9, 1975 (40 FR\neach nomination must affirmatively state\ning,\" will hold a meeting from 10 a.m. to\n47530)) announced four public meet-\nthat the nominee is aware of the nomina-\n4 p.m. on Wednesday, August 18, 1976\nings that were held across the coun-\ntion, is interested in participating in the\nin Room B-255, Building 225, of the Na-\ntry to give interested parties the oppor-\nmission of the current good manufactur-\ntional Bureau of Standards at Gaithers-\ntunity to present data, information, and\ning practice advisory committee, and\nburg, Maryland.\nviews concerning the draft current good\nindicate any areas of possible conflict of\nThe purpose of this meeting is to review\nmanufacturing practice regulations.\ninterest.\nFIPS TG-13 accomplishments to date\nThese meetings were held in November\nNominations are solicited from con-\nand to define future FIPS TG-13 task\n1975 in cooperation with various district\nsumer, industry, government, health\nactivities.\noffices of FDA. Based upon the infor-\nprofessional organizations, and the pub-\nThe public will be permitted to attend,\nmation derived from these meetings and\nlic. It is recommended that representa-\nto file written statements, and, to the\nnumerous comments on the draft docu-\ntives from each interest group develop a\nextent that time permits, to present oral\nment, significant alterations have been\nlist of nominees acceptable to the con-\nstatements. Persons planning to attend\nmade to the original draft.\nstituent organizations making up a\nshould notify the Acting Executive Sec-\nOn May 28, 1976, the Medical Device\nparticular interest group. The Commis-\nretary, Mr. Arthur F. Chantker, Institute\nAmendments of 1976 (Pub. L. 94-295)\nsioner will appoint as members those\nfor Computer Sciences and Technology,\nwere enacted into law, amending the\nnominecs who are most representative of\nNational Bureau of Standards, Washing-\nFederal Food, Drug, and Cosmetic Act\nan interest group to serve on the advisory\nton, D.C. 20234 (Phone-301-921-3485).\n(21 S.C. 201 et seq.). Section 520(f) of\ncommittee.\nDated: July 7, 1976.\nthe act provides the agency with author-\nInterested persons are invited to sub-\nity to develop and promulgate regulations\nERNEST AMBLER,\nmit names of nominees and accompany-\nrequiring that methods used in, and the\nActing Director.\ning information to:\nfacilities and controls used for the man-\n[FR Doc.76-20117 Filed 7-12-76;8:45 am]\nufacture, packing. storage, and installa-\nFood and Drug Administration, Bureau of\ntion of medical devices conform to cur-\nMedical Devices and Diagnostic Products,\nDivision of Compliance (HFK-123), 8757\nDEPARTMENT OF HEALTH,\nrent good manufacturing practice. These\nGeorgia Ave., Silver Spring, MD 20910.\nEDUCATION, AND WELFARE\nregulations are designed to assure that\ndevices will be safe and effective and\nDated: July 6, 1976.\nOffice of Education\notherwise in compliance with the act.\nWILLIAM F. RANDOLPH,\nADVISORY COUNCIL ON\nUnder section 520(f) (3) of the act, the\nActing Associate Commissioner\nENVIRONMENTAL EDUCATION\nCommissioner of Food and Drugs must\nfor Compliance.\nestablish an advisory committee for the\nMeeting; Amendment\npurpose of advising and making recom-\n[PR Doc.76-20184 Filed 7-12-76;8:45 am]\nIn FR oc.76-18397 appearing at page\nmendations on these regulations. Ad-\n25922 in the FEDERAL REGISTER of June 23,\nditionally, under this provision, the Com-\nADVISORY COMMITTEES\n1976, the first paragraph is amended to\nmissioner is authorized to request\ninclude a meeting of the Proposal Evalu-\nrecommendations from the advisory com-\nNotice of Meetings\nation Criteria work group to be held on\nmittee on any petitions submitted re-\nCorrection\nJuly 20-21, 1976 from 9:00 a.m. to 5:30\nquesting exemptions or variances from\np.m. in Room 2004, 400 Maryland Avenue,\ngood manufacturing practice require-\nIn FR Doc. 76-17818 appearing in the\nS.W., Washington, D.C. for the purpose\nments.\nissue of Friday, June 18, 1976, on page\nof preparing a draft report on their find-\nIn the near future, the agency intends\n24750, the fourth line in the second col-\nings.\nto publish in the FEDERAL REGISTER a pro-\numn should read \"vice; hyperthermia\nposed good manufacturing practice regu-\ndevice; mechanical cardiac resuscita-\nDated: July 9, 1976.\nlation for medical devices. The current\ntor;\".\nWALTER J. BOGAN, Jr.,\ngood manufacturing practice advisory\nDirector, Office of\ncommittee, when appointed, will review\nPublic Health Service\nEnvironmental Education.\nand comment on the proposed current\nTEXAS\ngood manufacturing practice regulations\n[FR Doc.76-20385 Filed 7-12-76; am]\nas well as on the comments received as a\nIntention to Redesignate Professional\nresult of the proposal.\nStandards Review Areas\nFood and Drug Administration\nAs required by section 520(f) of the\nNotice is hereby given that, pursuant\nact the advisory committee shall be com-\nto the order of the United States District\nADVISORY COMMITTEE FOR MEDICAL DE-\nposed of nine members selected from\nCourt in the case of Texas Medical Asso-\nVICES CURRENT GOOD MANUFACTUR-\nING PRACTICE REGULATIONS\ndifferent interest groups as follows:\nsiation et al V. Weinberger (U.S.D.C.,\n1. Three of the members shall be ap-\nW.D. of Texas, No. A-74-CA-108, Janu-\nRequest for Nominations for Members\npointed from persons who are officers or\nasy 9, 1976), and in the light of the with-\nThe Food and Drug Administration\nemployees of any State or local govern-\ndrawal of the Government's appeal from\n(FDA) describes the current status of\nment or of the Federal Government;\nthat order, the Department of Health,\ncurrent good manufacturing practice\n2. Two of the members shall be ap-\nEducation, and Welfare (the Depart-\nregulations and invites the submission of\npointed from persons who are repre-\nment) will undertake appropriate proce-\nnominations for membership to the Ad-\nsentative of interests of the device manu-\ndures to redesignate Professional Stand-\nvisory Committee for Current Good\nfacturing industry;\nards Review Organisation (PSRO) areas\nManufacturing Practice Regulations in\n3. Two of the members shall be ap-\nin the State of Texas in accord with sec-\npointed from persons who are repre-\ntion 1152(a) of the Social Security Act\naccordance with the requirements of\nsentative of the interests of physicians\n(42 U.S.C. 1320(1) and 42. CFR 101.1 et\nsection 520(f) of the Federal Food,\nand other health professionals;\nseq.\n&\nFEDERAL REGISTER, VOL. 41, NO. 135-TUESDAY, JULY 13, 1976\nGERALD\nLIBRARY\n28818\nNOTICES\nThe District Court Order set aside the\nTexas, but in other States, as discussed\nmaterial; to certify that true copies are\nnine PSRO areas designated in Texas\nin the preamble to the regulations (39\ntrue copies of the entire file; to certify\nunder the Department's regulations (42\nFR 10206, 3/18/74).\nthe complete original record; to certify\nCFR 101.48) and remanded the case to\nII.\nthe nonexistence of records on file; and\nthe Secretary to perform his statutory\nauthority to cause the HEW Seal to be\nfunction of designating appropriate\nThe specific procedures which the De-\naffixed to such certifications (34 FR\nPSRO areas in Texas, without \"inhibit-\npartment will follow in redesignating\n18049-50, dated November 7, 1969). The\ning external influences\" from Congress.\nPSRO areas in Texas pursuant to the\nCommissioner was also authorized at\nThe United States filed a Notice of Ap-\njudgment of the court will be set out in a\nsuch time to cause the HEW Seal to be\npeal in this case to the United States\nnotice to be published in the FEDERAL\naffixed or impressed to agreements,\nCourt of Appeals for the Fifth Circuit\nREGISTER in the near future. These pro-\nawards, citations, diplomas, and similar\non March 9, 1976. After further consid-\ncedures will enable the Secretary to take\ndocuments. The redelegation by the As-\neration of the need to expedite the es-\ninto consideration the criteria estab-\nsistant Secretary of certification au-\ntablishment of the Professional Stand-\nlished under 42 CFR 101.2 and to comply\nthorities did not rescind previous further\nards Review program in Texas and, in\nwith the District Court's suggestion that\nredelegations of authority made by the\nlight of the considerable delay that the\nHEW develop and preserve a \"full-scale\nCommissioner. The Commissioner pre-\ncompletion of the appeal process would\nadministrative record to remove any\nviously further redelegated these au-\nentail, the Secretary of Health, Educa-\ndoubts about the true basis of its forth-\nthorities (except authority to certify\ntion, and Welfare requested the Depart-\ncoming action.\"\nthat true copies are true copies of the\nment of Justice not to pursue the Appeal\nThe Department also plans to conduct\nentire file, and authority to certify the\nand to withdraw the Notice of Appeal.\nan informal secret ballot poll of all doc-\ncomplete original record) to appropriate\nThe Department of Justice has agreed\ntors of medicine or osteopathy engaged\nSSA positions, as set forth in 33 FR 2613-\nwith this recommendation and has taken\nin active practice in Texas to ascertain\n14, dated February 6, 1968; and 34 FR\nappropriate action to withdraw the ap-\nwhether they favor the designation of\n13046-47, dated August 12, 1969. Sub-\npeal.\nTexas PSRO areas on a local or statewide\nsequent to the Assistant Secretary's re-\nI.\nbasis. Physicians engaged in active prac-\ndelegation of November 7, 1969, the Com-\ntice in Texas will be advised further by\nmissioner made additional further re-\nThe Department's decision should not\nthe Department of the detailed proce-\ndelegations to SSA positions, as set forth\nbe read as indicating approval of or\ndures for the conduct of this poll. This\nin 37 FR 10602-3, dated May 25, 1972:\nagreement with either the factual or le-\npoll will be purely advisory to the Secre-\n38 FR 21681, dated August 10, 1973; and\ngal conclusions of the District Court. The\ntary in connection with the process of\n40 FR 25616, dated June 17, 1975. These\nDepartment continues to believe that\nrèdesignating areas and will not con-\nfurther redelegations did not include au-\nthe District Court's legal conclusion was\nstitute the poll required under section\nthority to certify the complete original\nclearly erroneous in ignoring the existing\n1152(g) of the Social Security Act (sec-\nrecord.\nadministrative record which contained\ntion 105 of Pub. L. 94-182).\nI. Notice is hereby given that the Com-\nthe basis for the Secretary's decision\nDated: July 8, 1976.\nmissioner has rescinded all prior further\n(Camp V. Pitts, 411 U.S. 138, (1973)).\nredelegations of the subject authorities\nMoreover, it is our view that the District\nDAVID MATHEWS,\nto SSA positions.\nCourt's conclusion that \"agency action is\nSecretary.\nII. Notice is also hereby given that the\ninvalid if based, even in part, on pres-\n[FR Doc.76-20178 Filed 7-12-76;8:45 am]\nCommissioner has concurrently further\nsures emanating from Congressional\nredelegated the following authorities to\nsources\" is incorrect since Congressional\nthe SSA positions specified below:\ninput is entirely appropriate in the quasi-\nSocial Security Administration\n1. Authority to certify true copies of\nlegislative function of rulemaking (see\nREDELEGATIONS OF AUTHORITY\nAngel V. Butz, 487 U.S. 967). Finally, the\nany books, records, papers or other doc-\nDistrict Court's opinion fails to recog-\nVarious Certifications and To Cause the\numents on file;\nnize the appropriate role of Congress in\nDepartment Seal To Be Affixed or Im-\n2. Authority to certify extracts from\noverseeing the \"application, administra-\npressed\nmaterial on file;\ntion, and execution\" of laws (2 U.S.C.\nThe Assistant Secretary for Adminis-\n3. Authority to certify that true copies\n190(d)) and further fails to follow the\ntration and Mangement of the Depart-\nare true copies of the entire record on\nsingle case which it cited as precedent,\nment of Health, Education, and Welfare\nfile;\nD.C. Federation of Citizens V. Volpe, 459\nhad redelegated to the Commissioner of\n4. Authority to certify the complete\nF. 2d 1231 (D.C. Cir. 1971). In that case\nSocial Security (the Commissioner), with\noriginal record on file;\nthe court plainly focused on irrelevant\nauthority to further redelegate, authority\n5. Authority to certify that particular\nCongressional pressure as being an un-\nto certify true copies of any books, rec-\nrecords are not on file; and\ndue influence on administrative action\nords, papers or other documents on file\n(459 F. 2d at 1248), which is clearly dis-\n6. Authority to cause the HEW Seal to\nwithin the Social Security Administra-\ntinguished from the Congressional at-\nbe affixed or impressed to those certifica-\ntempts in this case to call attention to\ntion (SSA); to certify extracts from such\ntions identified above.\nthe legislative history of the statute in-\nDelegates\nScope of authority\nvolved, which the Courts have always\n1. Deputy Commissioner\n1 and 2. SSA-wide.\nconsidered highly relevant to the process\n2. Associate Commissioner for Management\nof statutory construction.\nand Administration, and Deputy Asso-\nThe factual conclusion of the District\nclate Commissioner for Management\nCourt that the Secretary and HEW Ad-\nand Administration.\nministrators were, in fact, influenced by\n3. Associate commissioners and deputy as-\n8. Office or Bureauwide.\nthe \"financial leverage\" of the Congres-\nsociate commissioners; Director, Bu-\nsional sources of the alleged \"pressure\"\nreau of Health Insurance; Director and\nis plainly wrong, since the \"source\" ob-\nDeputy Director, Bureau of Hearings\nviously had no power to control the ap-\nand Appeals; and the Director, Office of\npropriation of funds to HEW. The De-\nAdvanced Systems.\n4. Those headquarters component head po-\n4. Componentwide.\npartment's decision to require local areas\nsitions and deputy component head\nin Texas was based on the Department's\npositions at the 1st organization level\nguidelines for designation of areas, as\nbelow the positions specified in items\npublished in regulations (42 CFR 101.2).\n2 and 3 above.\nThis was demonstrated by the adherence\n5. Regional commissioners and deputy re-\n5. Cases within the jurisdiction of regional\nof the Department to the guidelines in\ngional commissioners, Office of Program\ncomponents of the Office of Program\nthe designation of areas, not only in\nOperations.\nOperations.\nFEDERAL REGISTER, VOL. 41, NO, 135-TUESDAY, JULY 13, 1976\nNOTICES\n28819\nDelegates\nScope of authority\n6. Assistant Bureau Director, Operations,\n6. Cases within the jurisdiction of compo-\nand Deputy Assistant Bureau Director,\nnents reporting to the Assistant Bureau\nOperations, Bureau of Data Processing,\nDirector, Operations, Bureau of Data\nOffice of Program Operations.\nProcessing, Office of Program Opera-\ntions.\n7. Director and Deputy Director, Division of\n7. Divisionwide.\nAdjustment Operations; Director and\nDeputy Director, Division of Claims\nOperations; Director and Deputy Direc-\ntor, Division of Registration Opera-\ntions; Director and Deputy Director,\nDivision of Earnings Operations; and\nDirector and Deputy Director, Division\nof Health Insurance Operations; Bu-\nreau of Data Processing, Office of Pro-\ngram Operations.\n8. Assistant Bureau Director, Disability Op-\n8. Cases within the jurisdiction of compo-\nerations, and Deputy Assistant Bureau\nnents reporting to the Assistant Bu-\nDirector, Disability Operations, Bureau\nreau Director, Disability Operations,\nof Disability Insurance, Office of Pro-\nBureau of Disability Insurance, Office\ngram Operations.\nof Program Operations.\n9. Assistant Bureau Director, Systems and\n9. Cases within the jurisdiction of compo-\nMethods, and Deputy Assistant Bureau\nnents reporting to the Assistant Bu-\nDirector, Systems and Methods, Bureau\nreau Director, Systems and Methods,\nof Retirement and Survivors Insurance,\nBureau of Retirement and Survivors\nOffice of Program Operations.\nInsurance, Office of Program Opera-\ntions.\n10. Assistant Bureau Director, Technical Pol-\n10. Cases within the jurisdiction of compo-\nicy, and Deputy Assistant Bureau DI-\nnents reporting to the Assistant Bu-\nrector, Technical Policy, Bureau of\nreau Director, Technical Policy, Bu-\nHealth Insurance.\nreau of Health Insurance.\n11. Chief, Civil Actions Branch, Division of\n11. Cases within the jurisdiction of the Civil\nAppeals Operations, Bureau of Hearings\nActions Branch, Division of Appeals\nand Appeals.\nOperations, Bureau of Hearings and\nAppeals.\n12. Regional representatives and deputy re-\n12. Cases within the jurisdiction of regional\ngional representatives, Health Insur-\noffices of the Bureau of Health Insur-\nance.\nance.\n13. Regional chief administrative law judges,\n13. Cases within the jurisdiction of regional\nBureau of Hearings and Appeals.\noffices of the Bureau of Hearings and\nAppeals.\n14. Directors, SSA program service centers,\n14. Cases within the jurisdiction of 88A pro-\nBureau of Retirement and Survivors\ngram service centers, Bureau of Retire-\nInsurance, Office of Program Opera-\nment and Survivors Insurance, Office\ntions.\nof Program Operations.\n15. Program review officers, Office of Quality\n15. Cases within the jurisdiction of program\nAssurance, Office of Management and\nreview offices, Office of Management\nAdministration.\nand Administration.\n16. Directors and deputy directors, data op-\n16. Cases within the jurisdiction of data\nerations centers, Bureau of Data Proc-\noperations centers, Bureau of Data\nessing, Office of Program Operations.\nProcessing, Office of Program Opera-\ntions.\nIII. Notice is also hereby given that the Commissioner has rescinded all previous\nfurther redelegations to SSA positions of authority to cause the HEW Seal to be\naffixed or impressed to agreements; awards; citations; diplomas; or similar docu-\nments, and concurrently further redelegated such authority to the SSA positions\nspecified below:\nDelegates\nScope of authority\n1. Deputy Commissioner\n1 and 2. SSA-wide.\n2. Associate Commissioner for Management\nand Administration, and Deputy Asso-\nclate Commissioner for Management\nand Administration.\n3. Associate Commissioners and deputy as-\n3. Office or Bureauwide.\nsociate commissioners; Director, Bu-\nreau of Health Insurance; Director and\nDeputy Director, Bureau of Hearings\nand Appeals; and the Director, Office of\nAdvanced Systems.\n4. Those headquarters component head po-\n4. Componentwide.\nsitions and deputy component head po-\nsitions at the first organizational level\nbelow the positions specified in items\n2 and 3 above.\n5. Regional commissioners and deputy re-\n5. Cases within the jurisdiction of regional\ngional commissioners, Office of Program\ncomponents of the Office of Program\nOperations.\nOperations.\nFORD\n6. Regional representatives and deputy re-\n6. Cases within the jurisdiction of regional\n\"If\ngional representatives, Health Insur-\noffices of the Bureau of Health Insur-\nance.\nance.\nGERALD\nLIBRARY\nFEDERAL REGISTER, VOL. 41, NO. 135-TUESDAY, JULY 13, 1976\n28820\nNOTICES\nDelegates\nScope of authority\nCommittee Act of 1972 (P.L. 92-463), I,\n7. Regional chief administrative law judges,\n7. Cases within the jurisdiction of regional\nConstance B. Newman, am appointing\nBureau of Hearings and Appeals.\noffices of the Bureau of Hearings and\nthe following persons to servè terms on\nAppeals.\nthe National Mobile Home Advisory\n8. Directors, SSA program service centers,\n8. Cases within the jurisdiction of SSA\nCouncil:\nBureau of Retirement and Survivors\nprogram service centers, Bureau of Re-\nTo complete terms expiring December\nInsurance, Office of Program Opera-\ntirement and Survivors Insurance, Of-\n31, 1976.\ntions.\nfice of Program Operations.\nGOVERNMENT OFFICIALS\n9. Program review officers, Office of Quality\n9. Cases within the jurisdiction of program\nAssurance, Office of Management and\nreview offices, Office of Management\nWilliam E. Dell, Assistant to the Director, De-\nAdministration.\nand Administration.\npartment of Labor nad Industries, Seattle,\n10. Directors and deputy directors, data op-\n10. Cases within the jurisdiction of data\nWashington.\nerations centers, Bureau of Data Proc-\noperations centers, Bureau of Data\nMarion B. Robinson, Director, Division of In-\nessing, Office of Program Operations.\nspection Services, Columbia, South Caro-\nProcessing, Office of Program Opera-\nlina.\ntions.\nCOMMUNITY AND CONSUMER REPRESENTATIVES\nIV. Any actions heretofore taken by the incumbents of the positions specified in\nsections II and III above which, in effect, involve the exercise of authority further\nHerbert F. Hugo, President, Golden State Mo-\nredelegated by this document, are hereby affirmed and ratified.\nbilhome Owners League, Garden Grove,\nV. The rescissions and further redelegations specified in sections I through III\nCalifornia.\nabove are effective July 13, 1976. The incumbents of those positions further redele-\nINDUSTRY\ngated the subject authorities may not themselves redelegate such authorities.\nBill Novak, President, Gallatin Homes Cor-\nDated: July 6, 1976.\nporation, Belgrade, Montana.\nJ. B. CARDWELL,\nTo replace members whose terms ex-\nCommissioner of Social Security.\npired April 30, 1976, and who will serve\n[FR Doc.76-20131 Filed 7-12-76;8:45 am]\nterms expiring December 31, 1977:\nGOVERNMENT OFFICIALS\nDEPARTMENT OF HOUSING AND\nAdditionally, at this time, as a result\nC. Sutton Mullen, Administrator, Industrial-\nURBAN DEVELOPMENT\nof the resignation of two members and\nized Building Law, State Corporation Com-\nthe deaths of two others, there are four\nmission, Richmond, Virginia.\nAssistant Secretary for Consumer Affairs\nvacancies on the Council. These four\nKenneth E. Meiser, Public Advocate, Division\nand Regulatory Functions\nterms expire on December 31, 1976. The\nof Public Interest Advocacy, Department of\nPublic Advocate, Trenton, New Jersey.\n[Docket No. N-76-564]\nvacancies were for: one consumer repre-\nRichard Bullock, Chief, Mobile Home Section,\nNATIONAL MOBILE HOME ADVISORY\nsentative, one industry representative\nDepartment of Labor and Human Rela-\nCOUNCIL\nand two government representatives. Ap-\ntions, Madison, Wisconsin.\npointments for the four vacant terms\nFred H. Jolly, Director, Division of Environ-\nEstablishment\nwere made from those persons nominated\nmental Health Services, State Department\nThe National Mobile Home Construc-\nin 1975.\nof Health, Lincoln, Nebraska.\ntion and Safety Act of 1974 (Title VI of\nNominations for the 12 expiring terms\nCOMMUNITY AND CONSUMER REPRESENTATIVES\nthe Housing and Community Develop-\nwere requested at 41 FR 3500 on Janu-\nMargery Moore, Manpower Counselor, Orleans\nment Act of 1974) authorizes the Secre-\nary 23, 1976. In response to that request,\nCounty Council of Social Agencies\ntary of the Department of Housing and\n36 persons were nominated. Their quali-\n(OCCSA). Newport, Vermont.\nUrban Development to establish Federal\nfications as well as those persons previ-\nWilliam R. Palmer, Editor, Mobile Homeown-\nconstruction and safety standards for\nously nominated in 1975 and persons on\ner's Association of N.J., Inc., Newspaper,\nmobile homes. It provides for the ap-\nthe Council not serving until Decem-\nBirmingham, New Jersey.\npointment by the Secretary of a National\nber 31, 1976, were evaluated and appoint-\nRobert Myers, President, Michigan Mobile\nMobile Home Advisory Council composed\nments made from that group.\nHome Owner's Association, Ypsilanti,\nof 24 members. One-third of the mem-\nIn making its selections, the Depart-\nMichigan.\nbership of the Council is to be selected\nment, in general, sought to achieve geo-\nJane Conrad, American Mobile Home Associa-\nfrom each of the following categories:\ngraphic balance in the Council and to\ntion, Lakewood, Colorado.\n(a) Consumer organizations, community\nweigh that balance according to the size\norganizations, and recognized consumer\nof the mobile home industry and the\nINDUSTRY REPRESENTATIVES\nleaders; (b) the mobile home industry\nnumber of mobile homes in use in each\nPhilip J. Braff, President, Braff Building Com-\nand related groups including at least one\nregion of the country, and participation\npany, Madison, Ohio.\nrepresentative of small business; and (c)\nby persons who would present it with a\nWilliam Stewart, California Mobilehome\ngovernment agencies including Federal,\nbroad spectrum of views.\nDealers Association, Sacramento, Call-\nState and local governments. The Na-\nAdditionally, the Department decided\nfornia.\ntional Mobile Home Advisory Council\nthat: due to the wide interest in the\nCharles T. Ashford, Vice President, Corp.\nprovides advice to the Secretary on the\nFederal mobile home standards program\nPurchasing and Engineering, Redman In-\ndevelopment of initial Federal Mobile\nand the need to get the broadest input\ndustries, Dallas, Texas.\nHome Construction and Safety Stand-\npossible, no person would be permitted\nards and on changes in those standards.\nDaniel Siegel, President and Chairman of the\nto serve consecutive terms; that for the\nSection 6(c) of the National Mobile\nBoard, Siegel Mobile Home Group, Siegel\nsame reasons persons associated with the\nHome Advisory Council Charter stipu-\nfinancial or insurance communities who\nFinancial Services, Salt Lake City, Utah.\nlates that of the initially appointed\nhad no other interest in the program\nThe following members were previous-\nmembers, one-half shall be appointed for\nwould not be appointed at this time. It\nly appointed and will continue to serve\none year, and one-half for two years. The\nwas also decided that, since the Federal\none and two year terms were evenly dis-\nuntil December 31, 1976:\nmobile home standards and enforcement\ntributed among the three basic groups\nprograms contemplate participation to a\nJohn L. Adams, President, Florida Coalition\nwhich make up the Council, so that four\nsubstantial extent by the states, and since\nof Mobile Home Owners, Tampa, Florida.\nmembers of each group have one year\ninter-governmental participation may be\nPeter B. Maier, Director, Mobile Home Task\nterms and four members of each group\nachieved by other means, representatives\nForce, Center for Auto Safety, Washington,\nhave two year terms. The one year terms\nof Federal agencies would not be ap-\nD.C.\nexpired on April 30, 1976, and the initial\npointed to the Council.\nCharles H. Mann, President, Federation of\ntwo year terms expire on December 31,\nPursuant to the requirements of sec-\nMobile Home Owners, St. Petersburg, Flo-\n1976. All future terms are for two years\ntion 605 of Title VI of the Housing and\nrida.\nand expire on December 31 of the second\nCommunity Development Act of 1974\nDonald A. Barrow, Vice President, Skyline\nyear of the term.\n(P.L. 93-383) and the Federal Advisory\nCorporation, Elkhart, Indiana.\nFEDERAL REGISTER, VOL. 41, NO. 135-TUESDAY, JULY 13, 1976"
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