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Medical Devices
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Spencer C. Johnson Files (Ford Administration)
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The original documents are located in Box 7, folder "Medical Devices" of the Spencer C.
Johnson Files at the Gerald R. Ford Presidential Library.
Copyright Notice
The copyright law of the United States (Title 17, United States Code) governs the making of
photocopies or other reproductions of copyrighted material. The Council donated to the United
States of America his copyrights in all of his unpublished writings in National Archives collections.
Works prepared by U.S. Government employees as part of their official duties are in the public
domain. The copyrights to materials written by other individuals or organizations are presumed to
remain with them. If you think any of the information displayed in the PDF is subject to a valid
copyright claim, please contact the Gerald R. Ford Presidential Library.
VENT
Digitized from Box 7 of Spencer C. Johnson Files at the Gerald R. Ford Presidential Library
DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE
STATE
USA
The Honorable Harrison A. Williams, Jr.
Chairman, Committee on Labor and
DRAFT
Public Welfare
United States Senate
Washington, D.C. 20510
Dear Mr. Chairman:
We would Tike to offer our comments on the House and Senate versions of
the Medical Device Amendments to the Federal Food, Drug, and Cosmetic
Act (H.R. R. 11124 and S. 510).
These bills are similar in substance and would require premarket approval
of certain medical devices and authorize establishment of performance
standards for others. The bills would also strengthen the authority of
the Food and Drug Administration (FDA) to take regulatory action against
hazardous or deceptive medical devices, to prescribe good manufacturing
practice regulations, to inspect records, to register device manufacturers,
and to require maintenance of records and submission of reports concerning
these products.
During Congressional consideration of these bills, the Department
presented a number of statements and Departmental reports supporting
medical device legislation. These bills would remedy weaknesses in
FDA's present authority that have prevented the Agency from keeping pace
with safety and effectiveness questions posed by increasingly complex
new medical equipment.
In general, the Department prefers H.R. 11124, which is better drafted
and, in most respects, provides FDA with better authority to protect
consumers. However, we recommend that the conferees consider adoption of
the following changes in H.R. 11124, which represent compromises between
the Senate and House versions. We offer no suggestion concerning the
premarket approval provisions of the bills since we perceive no signi-
ficant substantive differences between them in this respect, except that
H.R. 11124 contains preferable provisions for statutory classification
of unique new devices into the premarket approval category.
Custom Devices
The custom device provisions of S. 510 allow use by practitioners of
custom devices which fail to comply with standards or premarket approval
requirements, but not as a course of conduct on many patients. H.R. 11124
contains custom device provisions that lack a prohibition of use of a
DRAFT
GERALD
Page 2 - The Honorable Harrison A. Williams, Jr.
DRAFT
custom device as a course of conduct; the House committee report explains
that some practitioners need to use custom devices routinely and that
abuse can be prevented by other provisions of the Federal Food, Drug,
and Cosmetic Act. A possible compromise would be to provide that custom
devices shall only be used as a course of conduct under conditions
prescribed in FDA regulations.
Good Manufacturing Practice Regulations
S. 510 offers a simpler procedure for promulgation of good manufacturing
practice regulations than H.R. 11124. While both bills call for an
opportunity for a hearing on good manufacturing practice regulations,
H.R. 11124 also requires review by³a special advisory committee.
Because there would be ample opportunity for industry, consumers, and
scientists to express their views on these regulations through comments
on the proposal, participation in any hearing, and FDA workshops and
meetings, the special advisory committee is unnecessary and, indeed, its
review would unnecessarily delay implementation of good manufacturing
practice regulations.
Records and Reports
Although we generally prefer the records and reports provisions of
H.R. 11124, the bill should omit the special criteria for recordkeeping
and reporting on class I (general controls) devices. No such limitation
appears in S. 510, which requires any device manufacturer to submit to
the Secretary, upon request, technical data and other data or information
applicable to its devices as may reasonably be required to carry out the
Federal Food, Drug, and Cosmetic Act. As a compromise, we suggest that
the provisions of H.R. 11124 be adopted but that the limitation on
records and reports concerning class I devices apply only to distributors
and not to manufacturers of these devices.
Restricted Devices
The "restricted device" provisions of H.R. 11124 are generally better
than the "prescription device" provisions of S. 510. However, H.R. 11124
specifically precludes FDA from restricting distribution or sale of a
device to a category of physicians based on special training or experience.
Under S. 510, FDA could differentiate between categories of licensed
physicians if necessary to assure safe use of the device taking into
account its potentiality for harmful effect or the collateral measures
for its use. With the increasing sophistication of medical devices, it
is important that FDA be able to consider the skill of intended users
DRAFT
Page 3 - The Honorable Harrison A. Williams, Jr.
when it establishes conditions for marketing of a device. Accordingly,
we recommend that the conferees not adopt the language in H.R. 11124
that prevents FDA from restricting devices to a category of physicians
possessing certain training or experience.
Proceedings of Advisory Committees
We question the advisability of the requirement in H.R. 11124 that
panels and advisory committees maintain transcripts of their proceedings.
We believe that maintenance of transcripts should be optional rather
than mandatory, to promote full and frank discussion. We therefore
recommend that this provision of H.R. 11124 be deleted.
Office To Assist Small Manufacturers of Medical Devices
The Department is opposed to the statutory establishment of a separate
office within the Department of Health, Education, and Welfare to
provide technical and other non-financial assistance to small manu-
facturers of medical devices, as proposed in H.R. 11124. Legislative
mandates of organizational structure result in rigidity and overlapping
functions and limit the Secretary's ability and discretion to organize
the Department in the most effective manner to achieve its objectives.
The Department strongly favors enactment of medical device legislation
and urges that the conferees adopt H.R. 11124, subject to the recommendations
in this letter.
We were advised by the Office of Management and Budget that there is no
objection to the presentation of this report from the standpoint of the
Administration's program.
Sincerely,
Secretary
DRAFT
HEALTH
THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE
M SEAL :
WASHINGTON. D. C. 20201
0 9 MAR 1976
The Honorable Harley O. Staggers
Chairman, Committee on Interstate
and Foreign Commerce
House of Representatives
Washington, D. C. 20515
Dear Mr. Chairman:
Your Committee, on January 21, 1976, ordered reported H.R. 11124, a bill
"To amend the Federal Food, Drug, and Cosmetic Act to provide for the
safety and effectiveness of medical devices intended for human use."
We have previously, by a letter dated February 5, 1976, provided our
general views in support of this legislation. A copy of that letter is
attached for your reference. We promised at that time to provide you
with a more detailed analysis outlining some of the specific concerns we
have with the bill. That analysis is enclosed for your information. We
would appreciate it if our earlier letter as well as the enclosed analysis
can be made a part of the permanent record of your Committee's considera-
tion of this bill.
We recommend that the bill, amended as we have proposed in the accompany-
ing analysis, be favorably considered by the Congress.
We are advised by the Office of Management and Budget that there is no
objection to the presentation of this report from the standpoint of the
Administration's program.
Throngone Sincerely, Rynh
Under Secretary
Enclosures
ANALYSIS OF H.R. 11124
1. Classification of Devices Intended for Human Use
We favor the provisions of the proposed new section 513 to the Federal
Food, Drug, and Cosmetic Act which would provide for classification by
the Food and Drug Administration (FDA) of all medical devices intended
for human use. The proposed classification system is consistent with
the 1970 recommendations of the Committee established by this Department,
and chaired by Theodore Cooper, M.D., the present Assistant Secretary
for Health, to make recommendations on the most appropriate means to
assure the safety and effectiveness of medical devices.
Shortly after the Cooper Committee Report, FDA was requested by former
Secretary Elliot Richardson to initiate the proposed medical device
classification process. To date, FDA has classified approximately 3,000
devices. This work will be of significant value in classifying devices
under this legislation.
2. Performance Standards
H.R. 11124 would add a new section 514 to the Act which would establish
a procedure for promulgating performance standards for those devices for
which general controls are insufficient to assure their safe and effective
performance, and for which sufficient information exists to establish
standards.
We believe that the procedure for the promulgation of a performance
standard as set forth in this section could be improved. The present
procedure would require the publication of two separate notices for
comments: one publication of a notice for the submission of comments
concerning the establishment of a standard (proposed section 514(b)),
and a second publication requesting submission of offers to develop a
proposed standard (proposed section 514(c)). We recommend that the two
steps be combined into one publication providing for the solicitation of
both comments on the need for a standard and the submission of offers to
develop a standard.
In our testimony, we also expressed concern that the section providing
for review of a device standard by an independent advisory committee
should be amended. Under proposed section 514(g)(5)(B), as well as
under proposed section 515(g)(2)(B), the Agency cannot use the panels
(who advise on classification and premarket approval) as the independent
advisory committee used for administrative review of proposed standards
and of premarket approval decisions. We urged that section 514(g)(5)(B)
be amended to allow FDA to merely disqualify those panel members who may
have prejudged an issue from service on an independent review advisory
committee. The Subcommittee staff has assured us that provisions in
- 2 -
section 514 (g) (5) (B) are intended merely to prohibit the use of the
entire classification panel that had considered a device as the in-
dependent advisory committee for review of a device standard or premarket
approval decision and that the provisions do not bar use of individual
members of a panel as members of the independent advisory committee. We
agree with this interpretation and, if it is correct, agree that the
bill need not be amended.
3. Premarket Approval
Premarket approval would be required under proposed section 515 for
devices that are of substantial importance in supporting, sustaining or
preventing impairment of human life or health, or present a potential
unreasonable risk of illness or injury, and for which insufficient
information exists to provide reasonable assurance of safety and
effectiveness under general controls, or general controls and perform-
ance standards, alone.
We believe that the requirement for premarket approval in H.R. 11124 is
too broad and that the criterion of unreasonable risk to health and the
substantial importance of supporting, sustaining, or preventing the
impairment of human life or health should be met before requiring premarket
approval. Accordingly, we recommend that the word "or" be changed to
"and" in section 513(a)(1)(C)(ii)(I).
In our testimony, we recommended that the provision for opportunity for
a formal evidentiary hearing, as an alternative to independent advisory
committee review of premarket approval decisions, be amended to provide
instead for an opportunity for an informal hearing (as defined in
section 3 of the bill). This recommendation was based on FDA's experi-
ence in removing unsafe and ineffective drugs from the market under a
similar requirement in current drug law. However, during Subcommittee
markup of the bill, Subcommittee staff explained that orders which are
subject to review under section 515(g)(1) of the bill would take effect
upon issuance, after merely an informal hearing and pending further
proceedings. Thus, withdrawal orders would take effect prior to the
formal evidentiary hearing or the review by an independent advisory
committee. This understanding, coupled with the substitution of
"questioning" for "cross-examination" at informal hearings, addresses
our concerns about unwarranted delays in terminating marketing of
devices subject to section 515.
4. Banned Devices
We support the change in proposed new section 516 to provide that, under
specified circumstances, the ban of a device shall take effect upon
publication and pending any further proceedings.
- 3 -
5. Records and Reports
At the hearing, we urged that the records and reports section
(section 519(a)(1)) be simplified by deletion of the provision barring
"requirements unduly burdensome to a device manufacturer, importer or
distributor taking into account his cost of complying with such require-
ments and the need for the protection of the public health and the
implementation of this Act." This language is unnecessary, would
engender controversy, and would not add any real safeguards to assure
that burdensome requirements are not imposed. We also expressed concern
that the restrictions in section 519(a)(5) upon FDA's authority to
require reports for devices subject only to general controls may be
misunderstood. We read these requirements as only restricting use by
FDA of the reporting authority to require that research be conducted
that will generate data meeting FDA reporting requirements, or to
require routine periodic reporting unrelated to public health needs,
except where necessary to determine if the device should be reclassified
or if the device is adulterated or misbranded. While the records and
reports provisions of H.R. 11124 are superior to those in S. 510, the
Senate version of the legislation, we believe they can be further
improved by the amendments we suggest.
Although we also recommended amending section 519(b)(2) to provide that
researchers and teachers who directly import devices for their own use
be subject to section 519 recordkeeping and report requirements, such an
amendment is no longer necessary because of clarifying amendments to the
investigational provisions of the bill which assure recordkeeping and
reporting by researchers.
6. Custom Devices
We support the objective of the provision allowing marketing of custom
devices, under proposed new subsection 520(b), that necessarily deviate
from requirements which would otherwise be applicable under a standard
or the premarket approval provisions of the bill. However, it is
essential that the custom device provisions not become a loophole that
will allow the marketing of dangerous or deceptive products. Section 520(b)
would not, as we read the bill, exempt any device from otherwise applicable
regulations for investigational devices, banned devices, or restricted
devices. It should also be made clear that FDA would be able to take
necessary action to curb a practitioner's use of a custom device on
several patients, where this use is repeated to such an extent that the
practitioner is in effect conducting unsupervised experiments, or
allowing the marketing of a product that would otherwise be unlawful.
We recognize the difficulty of drafting a provision limiting use of
custom devices as a course of conduct that prevents abuses, but does not
prevent use of custom products where justified by medical need. FDA
will endeavor to strike the necessary balance in its regulations
implementing section 520(b).
- 4 -
7. Restricted Devices
We are seriously concerned about a provision adopted during Subcommittee
markup of the bill which would curb FDA's authority to restrict use of a
medical device to a subcategory of physicians based on training and
experience when necessary to provide reasonable assurance of a device's
safety and effectiveness. This provision will seriously undermine the
Agency's ability to reduce public exposure to medical devices that may
be unsafe in the hands of practitioners who lack the training or experience
to use them. Also, the effect of H.R. 11124 may be to discourage FDA
approval for commercial marketing of products that will provide great
benefits to patients when used by skilled practitioners, but which
present unreasonable risk to patients if used too widely by the un-
trained. FDA may have to retain investigational controls over devices
for a lengthy period of time, since section 520(g), unlike section
520(e), authorizes FDA to distinguish between categories of physicians
based on qualifications. To assure that a device can be marketed safely
and effectively, FDA may also have to resort to its present authority
under section 502(f) of the Act, to require adequate directions for use
and promulgate conditional exemptions from this requirement. We therefore
recommend deletion of the phrase "(other than any condition which would
limit the use of a device to a particular category or categories of
physicians based on their training and experience)." This matter is a
serious concern with the increasing sophistication of medical devices.
8. Good Manufacturing Practice Advisory Committee
We still believe that it is unnecessary to require establishment of a
separate advisory committee to advise FDA concerning good manufacturing
practice regulations. FDA's present procedures provide ample opportunity
for industry, consumers, and scientists to make known their views in
this area. If a specific advisory committee on good manufacturing
practice regulations seems desirable, we will establish one. Moreover,
the Department is opposed generally to the statutory establishment of
advisory committees since it tends to result over time in the existence
of unnecessarily rigid committees which have outlived their usefulness.
We note that Congress supported this view in the Federal Advisory Committee
Act.
9. Proceedings of Advisory Panels and Committees
We question the advisability of the amendment adopted by the Subcommittee,
new subsection 520(i), that advisory panels and committees maintain
transcripts of their proceedings. It is FDA's policy to allow its
committees to decide for themselves whether they wish to have transcripts
or tapes made of their meetings as an aid to preparation of minutes, as
set forth in proposed section 2.313 of Title 21, Code of Federal
Regulations in FDA's proposed procedural regulations (Federal Register
of September 3, 1975, 40 FR 40748). This policy has been maintained to
- 5 -
protect the free interchange of ideas by these advisors. This concept
that internal communications of Government employees may be exempted
from public disclosure so as to promote full and frank discussion is set
forth in the Freedom of Information Act as incorporated into the Federal
Advisory Committee Act. We believe it consistent with this policy that
maintenance of transcripts be optional rather than mandatory. We
therefore recommend that this provision be deleted.
10. HEW Office to Provide Technical Assistance to Small Manufacturers
of Medical Devices
The Department is opposed to the statutory establishment of a separate
office within HEW to provide technical and other nonfinancial assistance
to small manufacturers of medical devices. Legislative mandates of
organizational structure result in rigidity and overlapping functions
and limit the Secretary's ability and discretion to organize the Depart-
ment in the most effective manner to achieve its objectives.
SERAL
DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE
The Honorable Harley O. Staggers
Chairman, Committee on Interstate
FEB 1976
and Foreign Commerce
House of Representatives
Washington, D. C. 20515
Dear Mr. Chairman:
There is before your Committee, as reported by the
Subcommittee on Public Health and Environment on
November 13, 1975, H.R. 11124, the "Medical Device
Amendments of 1975.' The reported bill is a clean bill
in lieu of H.R. 5545 as amended by the Subcommittee.
The Department of Health, Education, and Welfare supported
legislation similar to H.R. 11124 in the Ninety-third
Congress and has long endorsed the need for modernizing
the authority of the Food and Drug Administration (FDA)
over medical devices. We also presented testimony generally
favorable to H.R. 5545 at hearings before the Subcommittee
on July 28, 1975. Provided that it is amended to meet a
few continuing concerns outlined in an analysis which we
will shortly forward to your attention, the Department
vigorously supports H.R. 11124 as a balanced response to
this need.
If H.R. 11124 were enacted, FDA would use both existing
resources and a substantial part of the $17 million
requested increase for the Agency in the President's
1977 budget to implement a strengthened medical device
regulation program.
A number of changes made in the Subcommittee simplified
and thus improved administrative proceedings under the
bill. We favor, among other changes, the amended
investigational device provisions, the transitional
provisions for projects formerly categorized as "drugs,"
the substitution of "questioning" for "cross-examination"
at informal hearings, the provisions requiring FDA to make
The Honorable Harley O. Staggers
2
public a detailed summary of safety and effectiveness
information respecting certain devices, the exemption
of class I, General Control devices, from the biennial
inspection provision, and the understanding that the
restricted device provisions apply both as to effectiveness
as well as safety of a device.
In each of the areas where H.R. 11124 would strengthen
FDA's current authority, the Agency has been operating
under serious handicaps because of lack of legislative
authority to enable the Agency to keep pace with the
burgeoning growth in the introduction of complex new
medical equipment for use on or in humans.
We understand that certain industry representatives are
urging your Committee to use H.R. 11124 as a vehicle for
amending the criminal liability provisions of the Federal
Food, Drug, and Cosmetic Act with respect to all products
subject to the Act, not just medical devices. This subject
was never raised by any witness or member of the Subcommittee
at hearings on the device legislation. This Department
strongly opposes any amendment to the criminal liability
provisions of the Act. Our position has been set forth in
prior testimony and is summarized in the appended enclosure.
The present criminal liability provisions have been
consistently upheld by the courts and most recently by
the Supreme Court in United States V. Park, 421 U.S. 658
(1975) The present criminal liability standard is also
supported by consumer and public interest organizations.
We would even venture to question the unanimity within the
various regulated industries as to whether the long
established strict criminal liability standard should
be amended. Finally, of course, there is some question
as to whether an amendment to the criminal liability
provisions respecting all products subject to the Act may
be considered germane to medical device legislation.
The Honorable Harley O. Staggers
3
We are advised by the Office of Management and Budget nat
there is no objection to the presentation of this report
from the standpoint of the Administration's program.
Sincerely,
/s/Marjorie Lynch
Under Secretary
Enclosure
GERALD
STRICT CRIMINAL LIABILITY
The provisions of the Federal Food, Druq, and Cosmetic Act that define
criminal violations do not make knowledge or intent elements of the
offense. Rather, 21 U.S.C. §331 prohibits the enumerated "acts and the
causing thereof."
More than thirty years ago, in the Dotterweich case, the Supreme Court
declared, "[this] legislation dispenses with the conventional require-
ment for criminal conduct--awareness of wrongdoing" and punishes individuals
"though consciousness of wrongdoing be totally wanting." And since 1943
the Court has reaffirmed this interpretation on several occasions. Last
year when a divided Court of Appeals for the Fourth Circuit rejected the
standard it was quickly and unreservedly reversed by the Supreme Court
in the Park case.
There is no constitutional prohibition against punishing persons who
violate certain classes of laws (of which public health laws, including
the Act, are a principal example) even though they acted in good faith
or were ignorant of the facts which comprised the violation. The issue,
therefore, is whether such a standard serves a legitimate public purpose.
As Mr. Justice Frankfurter stated in Dotterweich:
"Hardship there doubtless may be under a statute which thus
penalizes the transaction though consciousness of wrongdoing be
totally wanting.
Balancing relative hardships, Congress has preferred to place
it upon those who have at least the opportunity for informing
themselves of the existence of conditions imposed for the protection
of consumers before sharing in illicit commerce, rather than to
throw the hazard on the innocent public who are wholly helpless."
The same reasoning was more recently echoed by Chief Justice Burger in
his opinion for the Court in the Park case.
FDA believes strongly that the strict liability standard is an indis-
pensable adjunct to its efforts to enforce the Act. The dimensions of
the agency's enforcement responsibilities are dramatized by a glance at
the food industry as an example. There are approximately 60,000 food
factories and warehouses in the United States and fewer than 1000 FDA
inspectors (many of whom are assigned full-time to other duties).
Inspections must, of necessity, be sporadic. It is clear therefore that
the purity of the nation's food supply rests, in the first instance, in
the hands of food producers and processors.
FORD & LIBRARY GERALD
2
Since the civil remedies available to FDA (seizure and injunction actions)
are essentially retrospective in effect, regulated firms can, and often
do, simply sit back and wait for FDA to act. It is far cheaper to risk
the loss of a few hundred or thousand dollars as a result of an occasional
seizure or injunction than to regularly allocate the resources necessary
to fully comply with the requirements of the Federal Food, Drug, and
Cosmetic Act. The primary impetus to self-regulation is the fear that
criminal prosecution may result from failure to take every precaution to
ensure that violations--and their potentially harmful consequences to
health--will not occur.
THE WHITE HOUSE
ACTION MEMORANDUM
WASHINGTON
LOG NO.:
Date: May 21
Time:
530pm
Jack Marsh
FOR ACTION: Spencer Johnson
CC (for information):
Jim Cavanaugh
David Lissy
Ed Schmults
Robert Hartmann (signing statement attached)
Max Friedersdorf
Ken Lazarus
FROM THE STAFF SECRETARY
DUE: Date:
Time:
May 24
400pm
SUBJECT:
S. 510-Medical Device Amendments of 1976
ACTION REQUESTED:
For Necessary Action
For Your Recommendations
Prepare Agenda and Brief
Draft Reply
For Your Comments
Draft Remarks
X
REMARKS:
Please return to Judy Johnston, Ground Floor West Wing
Cencur- I
1) See remd changes in statement
2) signing ceremony
PLEASE ATTACH THIS COPY TO MATERIAL SUBMITTED.
If you have any questions or if you anticipate a
delay in submitting the required material, please
DRAFT MESSAGE FOR THE PRESIDENT
Today, I have the pleasure of signing into law the
Medical Device Amendments of 1976 to the Federal Food,
Drug, and Cosmetic Act of 1938.
It is almost exactly 70 years since President Theodore
Roosevelt signed the Pure Food and Drugs Act of 1906,
the nation's first federal food and drug legislation designed
to protect the American consumer against health threats arising
from harmful substances and deceptive practices. Since then,
there have been a number of actions to strengthen and update
the structure of protection sought by President Roosevelt.
While we as a nation were able to take justifiable
pride in the laws providing for safety, honesty and efficacy
in the foods and drugs we consume, it became increasingly
clear that there remained a large, significant and growing
gap in that security.
Until today, the American consumer could not be sure
that a medical device used by his physician, his hospital,
or himself was as safe and effective as it could or should be.
In 1906, President Roosevelt had no need to ask for
legislation concerning medical devices; for the devices
used by physicians of his day were comparatively simple.
They stood at the edge of medicine, helpful but not essential,
and, therefore, posed no regulatory need.
By the 1960's, however, enormous advances in science
-2-
and technology moved medical devices from the edge close
to the center of the stage. Today devices are routinely
implanted in our bodies. They replace limbs, bones,
tissues, even entire organs. They permit treatment of
forms of illness that can be accomplished in no other way.
They magnify and speed ten thousandfold the diagnostic
power of the human eye and brain.
Medical and diagnostic devices have produced a thera-
peutic revolution, but in doing so, they have also become
more complex and less easily understood by those who use
them. When well designed, well made, and properly used
they support and lengthen life. If poorly designed, poorly
made, and improperly used they can threaten and impair it.
Despite the increasing importance of devices, the Food
and Drug Administration has had inadequate authority to deal
with them. FDA has had no reliable way of knowing how many
devices there are, who is making them, who is selling them,
what injuries they can cause, and when a manufacturer has
found it necessary to remove them from the medical market-
place.
In addition, no device was required to be proven safe
and effective prior to marketing, no matter how crucial it
might be to the person using it,
even if that use involved
implantation in his body.
-3-
Recognizing these and other deficiences, the
Administration ordered a study of the problem in 1969
and subsequently asked Congress to enact remedial legislation.
In its deliberations since that time, Congress benefited
greatly from the cooperation voluntarily extended by the
medical device industry who clearly saw the need for legislation
that would protect the consumer as well as the manufacturer
who refused to compromise with safety. Representatives
of consumers and health professionals also played an
important role.
The Medical Device Amendments of 1976 eliminate the
deficiencies that accorded FDA "horse and buggy" authority
to deal with "laser age" problems. It is important not only
in what it will do to protect the consumer; it is also
important as a symbol for the kind of regulation that I feel
is most appropriate to government. It does not represent
another expansion of government into affairs we might better
manage ourselves. Instead, this is an example of government
doing for the individual citizen what he or she cannot do
unaided.
I welcome this legislation and commend the FDA who
identified the need, cooperated in its development, and
finally, will be entrusted with its enforcement.
-4-
This agency daily faces a most difficult task --
preventing threats to the public health in a way that is not
onerous, but fully consonant with the principles of competi-
tive economic development on which this nation was built.
It is a task that requires determination, scientific skill,
judgement and most of all, compassion for the hopes and
needs of our fellow man. Dr. Alexander M. Schmidt,
Commissioner of Food and Drugs, has effectively taken
on the job of assuring that the hope and expectations
of the consumer for life giving drugs and devices are not
false promises.
I reaffirm my support for the fine work of the
Food and Drug Administration and the job ahead.
EXECUTIVE OFFICE OF THE PRESIDENT
OFFICE OF MANAGEMENT AND BUDGET
WASHINGTON, D.C. 20503
MAY 21 1976
MEMORANDUM FOR THE PRESIDENT
Subject: Enrolled Bill S. 510 - Medical Device Amendments
of 1976
Sponsor - Sen. Kennedy (D) Mass. and 8 others
Last Day for Action
May 28, 1976 - Friday
Purpose
Provides new authority to the Secretary of Health,
Education, and Welfare to assure the safety and effective-
ness of medical devices intended for human use.
Agency Recommendations
Office of Management and Budget
Approval
Department of Health, Education,
and Welfare
Approval (Signing
statement attached)
Veterans Administration
Approval
Department of Commerce
No objection
Department of Justice
No objection
Department of Defense
Defers to HEW
Discussion
S. 510 would amend the Federal Food, Drug and Cosmetic
(FDC) Act of 1938 to provide the Food and Drug Administra-
tion (FDA) in the Department of Health, Education, and
Welfare (HEW) with significant new authority to regulate
the safety and effectiveness of medical devices. The
enrolled bill is the first amendment to the FDC Act since
1938 dealing with medical devices and represents several
years of work by the Executive branch and the Congress to
develop acceptable legislation to assure that modern
medical devices are safe and effective.
2
Background. FDA's current regulatory authority under the
1938 Act is limited to action after a medical device has
been offered for introduction into interstate commerce and
only when the device is deemed to be "adulterated"
(i.e., unsterile) or "misbranded" (i.e., not properly
labelled). Once a device has been determined to be in
violation of the Act, the FDA is limited to seeking seizure
of the device by court order, seeking an injunction against
the violation, or recommending criminal prosecution.
The 1938 provisions were directed toward relatively simple
devices, such as surgical instruments, prosthetic devices,
and ultraviolet lights whose safety or proper functioning
could generally readily be determined by experts. It was
also directed at protecting the public against quack
machines and other fraudulent devices. The major concern
with devices at the time the 1938 Act was enacted was
assuring truthful labeling.
Since then, rapid technological change in the medical device
field has led to the introduction of many highly sophisticated
modern devices, such as heart pace-makers, kidney dialysis
units and artificial blood vessels and heart valves. These
devices are so intricate and complex that skilled health
professionals are unable to ascertain whether they are
defective without careful and thorough testing. Even
where devices are determined by FDA to be unsafe or of
questionable effectiveness, lengthy court proceedings are
usually required to remove such devices from the market.
In Congressional hearings on S. 510 and related bills, FDA
testified that litigation in some cases lasted for five to
seven years costing the Federal Government several millions
of dollars. To avoid such extensive court battles, FDA
has resorted to classifying certain products, e.g., soft
contact lenses, pregnancy kits, and intrauterine contra-
ceptive devices, as drugs if the intended reaction is
chemical, or if the potential hazards of the product may
be reduced through drug controls, since FDA exercises pre-
market clearance authority over drugs (but not devices)
under the FDC Act. Moreover, according to HEW, many unsafe
devices which cannot technically be found to be in
violation of the adulteration or misbranding provisions
of the FDC Act lie outside the range of FDA's regulatory
authority. S. 510 would eliminate the need for lengthy
court proceedings to remove unsafe or ineffective devices
from the market.
3
The detailed provisions of the bill are explained in
HEW's attached views letter and in the accompanying
Congressional committee reports on the measure.
Classification of Devices. S. 510 would classify all
medical devices intended for human use into three categories
based upon the extent of control necessary to insure the
efficacy and safety of each such device:
(1) general controls (Class I) -manufacturer registra-
tion, recordkeeping and reporting requirements, good
manufacturing practice regulations, etc. , would be established
for devices for which such controls would be adequate to
assure safety and efficacy;
(2) performance standards (Class II) - HEW would
develop and issue performance standards for those devices
for which general controls would be inadequate and for
which performance standards can be devised; and
(3) premarket approval procedures (Class III) --
manufacturers would be required to submit safety and
efficacy data to HEW before marketing a device where
insufficient information exists to assure that general
controls and performance standards would provide reasonable
assurance of the safety and effectiveness of devices, and
where such devices are purported or represented for a use
in supporting or sustaining human life or for a use which
is of substantial importance in preventing impairment of
human health, or which present a potential unreasonable
risk of illness or injury.
The bill would authorize the Secretary to ban devices
intended for human use which presented substantial deception
or an unreasonable and substantial risk of illness or
injury.
S. 510 would regulate device marketing through the classi-
fication system, i.e., by authorizing HEW to classify
devices in one of the three specified categories. Manu-
facturers would be permitted to file applications for the
approval of devices in Classes I, II, or III, and the HEW
Secretary would be empowered to either approve or deny the
applications through the issuance of orders. Manufacturers
and other applicants adversely affected by the HEW regula-
tions or orders would be permitted to appeal such decisions
to the appropriate United States Court of Appeals.
4
General Provisions. In addition to prescribing detailed
procedures for the classification of devices and the
judicial review of regulations and orders, S. 510 contains
a number of general provisions dealing with the regulation
and control of medical devices for human use. Briefly,
the bill would:
-- provide an exception for certain "custom devices"
and devices used in investigational use;
-- authorize HEW to issue good manufacturing practice
requirements;
-- provide for the release of safety and effectiveness
information to the public;
-- require advisory panels and committees to maintain
transcripts of any proceedings;
-- authorize HEW to enter into contracts for research,
testing and demonstrations of devices;
--- provide for Federal preemption of State and local
requirements for medical devices;
-- require the registration and inspection (every two
years) of manufacturers of Class II and Class III devices;
-- provide for the temporary administrative detention
of devices in violation of the FDC Act;
-- authorize HEW to provide trade secrets and other
confidential information to persons under contract with
the Secretary;
-- establish a presumption of existence of connection
with interstate commerce required to establish jurisdiction
in legal actions to enforce the Act with respect to devices;
-- require HEW to establish an office to provide
technical and other nonfinancial assistance to small
manufacturers to assist them in complying with the Act.
Costs. As indicated above, HEW already undertakes some
medical device regulatory activity. The following table
shows current and HEW's proposed supplemental funding
levels if you approve S. 510:
GERALD
5
Budget Authority
(In $ millions)
1976
actual
1977
1978
1979
HEW current activity
level projected
8.2
9.4
23.1
36.7
HEW proposed funding
for S. 510 authorities
--
13.6
13.6
13.4
8.2
23.0
36.7
50.1
Proposed position levels 281
723
1,013
1,428
We have not had an opportunity to review the HEW estimates
and HEW Under Secretary Lynch states in the Department's
letter:
"I recognize that in earlier correspondence with
the Congress we indicated that no funds beyond the
President's Budget would be sought to implement this
activity in fiscal year 1977. Nevertheless, I would
like to retain the option of submitting a supple-
:
mental request for your consideration.
Recommendation
HEW fully supports enactment of S. 510. The Department
notes that it has worked with the Congress for several
years to perfect the legislation and that "In its present
form, the bill embodies nearly all of the amendments
suggested by the Department and combines the best features
of the Senate and House-passed versions." HEW has prepared
a draft signing statement for your consideration and
recommends a signing ceremony.
********
S. 510 is similar to medical device legislation submitted
by the Executive branch to the 93rd and prior Congresses.
It represents Administration proposals and is strongly
supported by HEW, the medical device industry and the
Congress--an unusual display of unanimity. Accordingly,
we recommend that you approve S. 510 with a signing statement
along the lines of the one proposed by HEW.
James Director for
Legislative Reference
Enclosures
THE
ACKIT
E
DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE
DETAR
USA
The Honorable James T. Lynn
Director, Office of Management
MAY
20 1976
and Budget
Washington, D. C. 20503
Dear Mr. Lynn:
This is in response to your request for a report on S. 510,
an enrolled bill "To amend the Federal Food, Drug, and
Cosmetic Act to provide for the safety and effectiveness
of medical devices intended for human use, and for other
purposes. "
In short, the Department recommends enactment of this bill
because it is a well balanced and meticulously formulated
piece of legislation which properly addresses an important
aspect of public health and safety protection, without unduly
restricting an innovative and important health industry.
The enrolled bill is summarized in detail at Tab A. Briefly
stated the bill would amend the Federal Food, Drug, and
Cosmetic Act to provide the Secretary of Health, Education,
and Welfare with a basis for a comprehensive program to
protect the public from unsafe or ineffective medical devices.
It would require premarket approval of certain medical devices,
and permit promulgation of performance standards to assure
safe and effective performance of others for which premarket
approval is not needed. It would also provide new or
strengthen existing authority to prescribe good manufacturing
practice regulations; require registration of device manu-
facturers; authorize the Secretary to take remedial action
against devices presenting an unreasonable risk of substantial
harm to the public health; require maintenance of records
and submission of reports; and authorize the Secretary to
inspect records, processes, controls and facilities of
establishments which manufacture restricted devices.
The Honorable James T. Lynn
2
The bill presents a balanced regulatory framework incorporating
the basic principle that the least regulation consistent
with public health protection is the best. General controls
(e.g., manufacturer registration, recordkeeping and reporting
requirements, and good manufacturing practice regulations)
are preferred to performance standards, and performance
standards are preferred to premarket approval, where
general controls, or general controls and standards, can
provide reasonable assurance of device safety and effective-
ness. This regulatory framework would assure, on the one hand,
adequate protection to the public, including health pro-
fessionals, from unsafe and ineffective medical devices,
and, on the other, that advances in the state of the art of
medical device technology would not be stifled by unnecessary
regulatory restrictions.
The bill recognizes the need to minimize any potential economic
impact on the medical device industry, especially the small
manufacturers who have been responsible for the development
of many new and innovative devices. It would provide the
Secretary with the authority to exempt, consistent with
the protection of public health, certain devices subject
to general controls from the requirements of registration,
recordkeeping and reporting, and good manufacturing practices,
while requiring adherence to other regulatory requirements
such as the prohibitions of misbranding and adulteration.
In each of the areas where S. 510 would strengthen our current
authority we have been operating under a serious handicap.
Legislative authority to keep pace with the ever increasing
variety of complex new medical equipment being introduced
for use on, or for implantation in, the body is long overdue.
The Department has fully supported enactment of S. 510,
both in testimony and in reports, and has worked with the
Congress for several years to perfect the legislation.
In its present form, the bill embodies nearly all of the
amendments suggested by the Department and combines the best
features of the Senate and House-passed versions.
The Honorable James T. Lynn
3
For the reasons given, we urge that the enrolled bill be
approved.
The amendments are a fine tribute to the diligent and tire-
less efforts and cooperation of a number of highly publicly
motivated individuals representing the Administration,
Congress, consumers, health professionals, and industry.
A ceremony for the signing of the medical device amendments
by the President would be a most fitting recognition of
the importance of this legislation.
We have enclosed at Tab B, for your information, preliminary
cost estimates for the bill. The projection includes a 1977
supplemental. I recognize that in earlier correspondence
with the Congress we indicated that no funds beyond the
President's Budget would be sought to implement this activity
in fiscal year 1977. Nevertheless, I would like to retain the
option of submitting a supplemental request for your
consideration. A draft signing statement may be found at
Tab C.
Sincerely,
Marjone bynch
Under Secretary
Enclosures
SUMMARY OF THE PROVISIONS OF ENROLLED BILL S. 510
Classification of Medical Devices Intended for Human Use
Section 2 of the enrolled bill would amend the Federal Food,
Drug and Cosmetic Act (hereinafter referred to as "the Act")
by adding a new section 513, which would classify all medical
devices intended for human use into three categories based
upon the extent of control necessary to insure the safety and
efficacy of each such device. The three categories are:
(1) Class I, General Controls (e.g. manufacturer registra-
tion, recordkeeping and reporting requirements, and good
manufacturing practice regulations) - devices for which controls
other than standard-setting and premarket approval are
sufficient to assure safety and effectiveness or for which
insufficient information exists to determine that general
controls are sufficient but which are not purported or
represented to be for a use in supporting or sustaining
human life or for a use which is of substantial importance
in preventing impairment of human health and which do not
present a potential unreasonable risk of illness or injury;
(2) Class II, Performance Standards - devices for which
general controls are insufficient to provide reasonable
assurance of safety and effectiveness and for which there
is sufficient information to establish a performance standard
to provide such assurance; (3) Class III, Premarket Approval -
devices for which insufficient information exists to assure
that general controls and performance standards would provide
reasonable assurance of safety and effectiveness and which
are purported or represented to be for a use in supporting
or sustaining human life or for a use which is of substantial
importance in preventing impairment of human health, or
which present a potential unreasonable risk of illness or
injury.
New section 513 of the Act would further require the establish-
ment of expert panels to make classification recommendations
to the Secretary of Health, Education, and Welfare (hereinafter
referred to as "the Secretary"). These classification panels
978839
2
would be organized according to the various fields of
clinical medicine and fundamental sciences in which devices
intended for human use would be used. After panel recommen-
dations, the Secretary would provide an opportunity for
comment, and, thereafter, classify devices by regulation.
The Secretary would be authorized to change the classification
of a device based upon new information and revoke any
regulation or requirement in effect under new section 514
or 515 of the Act with respect to the device.
Performance Standards
Section 2 of the enrolled bill would also amend the Act
by adding a new section 514, which would authorize the
Secretary to establish, by regulation, a performance standard
for a class II device (including a device in class III,
the reclassification of which into class II is effective
upon the effective date of a performance standard for it).
Such performance standards established for devices would
provide reasonable assurance of safe and effective performance;
and, where necessary, would include provisions respecting:
(1) the construction, components, ingredients, and properties of
the device and its compatibility with power systems; (2) the
testing of the device; (3) demonstration that the device is
in conformity with portions of the standards for which tests
were required; (4) the measurement of the performance
characteristics of the device; and (5) restrictions on
the distribution of a device. Performance standards
would, where appropriate, prescribe certain labeling
for a device.
Premarket Approval
Section 2 of the enrolled bill would amend the Act by adding
a new section 515, which would prescribe the authority and
responsibilities of the Secretary with respect to premarket
approval of devices classified in class III.
3
A device, which had not been introduced or delivered for
introduction into interstate commerce before the date of
enactment of this enrolled bill, and which had been classi-
fied in class III, would be able to be marketed only after
an application for premarket approval had been approved.
A class III device which had been introduced or delivered
for introduction into interstate commerce before the date
of enactment of this enrolled bill or was substantially
equivalent to another device which had been so introduced
or delivered for introduction into interstate commerce
would have to follow the application procedure only after
the Secretary had promulgated a regulation to require premarket
approval pursuant to a notice and comment procedure set
forth in this section.
Any person would be authorized to file an application for
premarket approval for a class III device and the Secretary
would be required to refer such application to the appropriate
classification panel under new section 513 of the Act for
study and for submission of a report and recommendation
respecting approval of the application. Within 180 days
from the receipt of the application, the Secretary would
approve or deny approval of the application, unless the
period were extended by agreement between the Secretary and
the applicant in cases in which the device had been introduced
or delivered for introduction into interstate commerce before
enactment of the enrolled bill or was substantially similar
to another device which had been so introduced or delivered
and the continued availability of the device was necessary
for the public health.
The Secretary, upon obtaining advice on scientific matters
from a classification panel, after notice and opportunity
for an informal hearing, could issue an order withdrawing
approval of an application for premarket approval.
The enrolled bill would authorize an alternative procedure
for gaining approval of an application for premarket approval
of a class III device whereby, an appropriate product
development protocol (PDP) was developed and approved by
the Secretary. A product development protocol would be
a procedure whereby the development of a product and the
4
development of data necessary to demonstrate safety and
effectiveness would evolve simultaneously. Approval by
the Secretary of a notice of completion of a product
development protocol would be the equivalent of approval
of an application for premarket approval.
Banned Devices
Section 2 of the enrolled bill would amend the Act by adding
a new section 516, which would authorize the Secretary to
ban a device intended for human use which presented substantial
deception or an unreasonable and substantial risk of illness
or injury.
Judicial Review
Section 2 of the enrolled bill would amend the Act by
adding a new section 517, which would prescribe procedures
for judicial review of regulations and orders specified in
this section.
Notification and Other Remedies
Section 2 of the enrolled bill would amend the Act by adding
a new section 518, which would authorize the Secretary,
upon his determination that a device intended for human use
presents an unreasonable risk of substantial harm to the
public health, that notification is necessary to eliminate
the unreasonable risk, and that no other more practicable
means are available to eliminate such risk, to issue an order
requiring notification of the risk to all health professionals
who prescribe or use the device and to any other person
(including a device user) who should properly receive such
notification in order to eliminate the risk. If, after affording
opportunity for an informal hearing, the Secretary determines
that notification by itself would not be sufficient to eliminate
the unreasonable risk of substantial harm, he could order the
manufacturer, importer, or distributor of the device to submit
a plan to repair, replace or refund the purchase price of the
device.
However, compliance with an order would not relieve persons
from liability under Federal or State law, although any
value received by a plaintiff as a result of such order
would be taken into account in awarding damages.
5
Records and Reports on Devices Intended for Human Use
Section 2 of the enrolled bill would amend the Act by adding
a new section 519, which would require manufacturers,
importers, and distributors of devices intended for human use
to establish and maintain records, make reports and provide
information required by regulations of the Secretary to assure
that devices were not adulterated or misbranded and to
otherwise assure their safety and effectiveness.
General Provisions Respecting Control of Devices Intended for
Human Use
Section 2 of the enrolled bill would amend the Act by adding
a new section 520, which would establish general provisions
respecting control of devices intended for human use.
Custom Devices
The enrolled bill would allow "custom devices" to deviate
from performance standards and requirements for premarket
approval in order to comply with an order of an individual
physician, dentist, or other specially qualified person if
(1) the device was not generally available in finished
form for purchase or dispensing upon prescription, and was
not offered through labeling or advertising by the manu-
facturer, importer, or distributor thereof for commercial
distribution, and (2) the device (a) was either intended
for use by an individual patient named in an order of
a physician or dentist (or other specially qualified person
so designated) or intended solely to meet the special needs
of such physician, dentist, or other specially qualified
person in the course of his practice, and (b) was not
generally available to or generally used by other physicians,
dentists, or other designated persons.
Restricted Devices
The enrolled bill would authorize the Secretary to restrict
the sale, distribution, or use of a device if, because of
its potentiality for harmful effect or as a result of the
collateral measures necessary to its use, the Secretary
determines that there can not otherwise be reasonable assurance
6
of its safety and effectiveness. The label of such a device,
called a "restricted device" would have to bear such appro-
priate statements of restrictions as the Secretary may
prescribe.
Good Manufacturing Practice Requirements
The enrolled bill would authorize the Secretary to prescribe
regulations requiring that the methods used in, and the
facilities and controls used for the manufacture, packing,
storage, and installation of devices conform to good
manufacturing practice in order to assure safety and
effectiveness. Such regulations could be promulgated only
after opportunity for oral hearing and only after the opportunity
to submit recommendations with respect to such proposed
regulations had been afforded to a nine-person advisory
committee established by the Secretary. Persons subject
to good manufacturing practice requirements would be able
to petition for exemptions or variances from such requirements.
A petition for an exemption for a device could be approved
if; the Secretary determined that compliance with the contested
requirement was not necessary to assure that the device
was safe, effective, and otherwise in compliance with the
Act. Additionally, a petition for a variance for a device
could be approved if the Secretary determined that the
proposed methods, facilities, and controls to be used
were sufficient to assure that the device was safe, effective,
and otherwise in compliance with the Act.
Exemption for Devices for Investigational Use
The enrolled bill would authorize the Secretary to exempt
a device from the requirements of the Act if it was intended
for investigational use.
Release of Safety and Effectiveness Information
The enrolled bill would require the Secretary to promulgate
regulations under which a detailed summary of information
respecting the safety and effectiveness of a device would
be made available to the public. Such information would be
made public upon approval, denial of approval, or withdrawal
7
of approval of an application for premarket approval; or upon
the revocation of an approved product development protocol
(PDP), an order declaring a PDP completed or not completed,
an order revoking the approval of a device approved under
the PDP procedure, or an order approving, disapproving, or
withdrawing approval of an application for exemption for
investigational use of a device.
Proceedings of Advisory Panels and Committees
The enrolled bill would require each classification panel,
each advisory committee established to review performance
standards, and each advisory committee established to review
the Secretary's action with respect to class III devices
to make and maintain a transcript of any of its proceedings.
Confidential information would be deleted.
Traceability Requirements
The enrolled bill would require that no regulation could
impose requirements for the traceability of a type or class
of device unless such requirements were necessary to assure
the protection of the public health.
Research and Development
The enrolled bill would authorize the Secretary to enter
into contracts for research, testing, and demonstrations
respecting devices and would authorize the Secretary to
obtain devices for such purposes without regard to sections 3648
and 3709 of the Revised Statutes (relating to advanced payment
and procurement).
Transitional Provision for Devices Considered as
New Drugs or Antibiotic Drugs
The enrolled bill would prescribe transitional provisions
for devices in various stages of regulation which had been
classified as new drugs or antibiotic drugs. Such devices
would be classified in class III unless the Secretary had
classified them into class I or class II pursuant to a
petition filed by the manufacturer or importer of the device.
8
State and Local Requirements Respecting Devices Intended
for Human Use
Section 2 of the enrolled bill would amend the Act by adding
a new section 521, which would preempt State and local
requirements for medical devices intended for human use
that differed from or were in addition to requirements
established by the Secretary, although the Secretary could
exempt a requirement of a State or locality from the
preemption provision were the requirement more stringent
than the Federal requirement or were the requirement required
by compelling local conditions and were a device which
complied with the requirement not in violation of the Act.
Export of Devices
Section 3 (f) of the bill would amend section 801 (d) of the
Act to prohibit the export of devices that did not comply
with the provisions of the Act unless they accorded to the
specifications of the foreign purchaser, were not in conflict
with the laws of the importing country, were labeled on
the outside of the shipping package as intended for export,
and the health agency of the foreign country (or the Secretary
if there were no such agency) would have to determine
for devices which did not comply with any applicable
performance standard, or premarket approval requirement, or
which were exempt or banned that export was not contrary to
public health.
Registration of Manufacturers of Drugs and Listing of Drugs
Section 4 of the enrolled bill would amend section 510 of
the Act (relating to registration of manufacturers of drugs
and listing of drugs) to make the provision applicable to
device manufacturers and to require that every establishment
registered under the provisions of section 510 which engaged
in the manufacture, propagation, compounding, or processing
of class II or class III devices be inspected at least once
every two years pursuant to section 704 of the Act.
9
Official Names
Section 5 of the enrolled bill would amend section 502 (e)
of the Act (relating to the use of established names for
drugs) and section 508 of the Act (which provides authority
to designate official names for drugs) to make these sections
applicable to devices.
Inspections Relating to Devices
Section 6 of the enrolled bill would amend section 704 (a)
of the Act (relating to inspections of establishments in
which foods, drugs, devices or cosmetics were manufactured,
processed, packed or held for introduction into interstate
commerce) to render provisions now applicable to establishments
in which prescription drugs are manufactured applicable
to establishments in which restricted devices are manufactured,
to render the provisions with respect to access to research
data applicable to inspections with respect to restricted
devices, and would add a new section 704 (e) to assure access
by officers or employees of the Secretary to records required
to be maintained.
Administrative Restraint
Section 7 of the enrolled bill would amend section 304 of the
Act (relating to seizure of products in violation of the Act)
to add a new provision (section 304 (g) authorizing temporary
administrative detention of devices)
Confidential Information; Presumption of Interstate Commerce
Section 8 of the enrolled bill would add two new sections,
708 and 709 to the Act. New section 708 would authorize
the Secretary to provide trade secrets and other confidential
information to persons under contract with the Secretary
and only require security precautions as a condition to
receipt of such information. New section 709 would establish
a presumption of existence of connection with interstate
commerce required to establish jurisdiction in actions
to enforce the Act with respect to devices.
10
Color Additives
Section 9 of the enrolled bill would amend section 706 of
the Act (relating to color additives) to render a color
additive in a device subject to the provisions of that
section if the color additive came into contact with the
body of man or other animals for a significant period of time,
and would authorize the Secretary to designate by regulation
the uses of color additives in or on devices which are
subject to section 706.
Assistance for Small Device Manufacturers
Section 10 of the enrolled bill would require the Secretary
to establish, within the Department of Health, Education,
and Welfare, an office to provide technical and other non-
financial assistance to small manufacturers of devices to
assist them in complying with requirements of the Act.
In this regard, the Secretary, in order to expedite
implementation of. this section, will publish a notice in
the Federal Register identifying an existing organizational
entity within the Food and Drug Administration (FDA) to
carry out the responsibilities of this section. This notice
will provide the name, mailing address, and phone numbers of
the FDA unit which manufacturers can contact to obtain
information to assist them in complying with the requirements
of this Act. This unit will be a part of the office of FDA
that provides guidance to regulated industry in general. The
unit will provide printed informational materials, respond
to inquiries about statutory requirements, and conduct meetings,
workshops, and symposia designed to acquaint manufacturers
with their regulatory responsibilities under this legislation.
Medical Devices Program
Resource Requirements with
Medical Devices Legislation
1977
1977 with
1976
Request
Supplemental
1978
1979
1980
1981
Pos.
6000
Pos.
$200
Rom.
4000
For.
$000
Too.
8000
Pos.
0000
Ina.
8000
Classification
36
1,036
40
1,208
50
2,790
23
2,040
25
2,040
25
2,040
23
2,040
Pre Market Approval
-
--
A
134
84
2,394
194
5,897
209
6,968
209
7,073
209
7,073
Regulation
3
78
s
176
13
433
10
503
18
505
18
305
18
503
Registration
s
136
e
156
21
698
31
1,038
31
1,108
31
1,108
313ᵗ
1,105
Records and Reports
4
104
4
104
14
611
19
799
24
952
23
1,105
29
1,140
Standards
35
1,310
44
1,831
34
2,435
S4
4,938
119
8,471
144
7,803
144
7,978
Regulatory Operations
43
1,115
43
1,176
97
2,797
97
3,334
167
4,939
167
3,959
187
6,099
Research and Testing
16
782
16
963
H
1,812
51
3,609
71
4,908
91
6,018
91
6,153
Surveillence/Spec. Invest.
43
1,118
43
1,110
34
1,343
54
1,620
64
1,653
69
2,043
69
2,078
Inspection
95
2,470
100
2,568
300
7,565
440
12,933
700
20,325
750
23,570
750
23,020
TOTAL Program
281
9,222
311
9,364
723
23,060
1,013
35,733
1,428
50,131
1,353
37,224
1,353
58,049
GERALD
FORD
LIBRARY
5/19/76
Increases for Implementing
Medical Device Lagislation A
1977
2977 Increase
Supplemental
2973 Increase
1979 Increase
1980 Increase
1981 Incresse
Pos.
$000
FDS.
4000
Pog.
4000
Pco.
$000
Pon.
$000
POOR
$000
Classification
4
202
10
1,502
-25
-750
-
-
-
-
-
1
Pre Market Approval
4
134
so
2,260
110
3,503
13
1,071
-
103
-
-
Regulation
3
98
10
259
-
70
-
-
-
-
-
-
Registration
-
-
15
542
10
340
-
70
-
-
-
-
Records and Reports
-
-
10
507
5
180
3
133
3
133
-
35
Standards
D
571
10
554
30
2,503
35
1,533
25
1,332
-
173
Regulatory Operations
3
30
31
1,621
-
537
70
2,645
20
950
-
140
Research and Testing
-
151
13
849
20
1,797
20
1,299
20
1,110
-
140
--
Survaillence/Spec. Invest.
-
-
11
423
-
77
ID
235
5
188
-
35
Inspections
s
98
200
4,997
140
5,370
260
7,390
30
3,245
-
350
TOTAL Program
30
1,342
422
13,516
290
13,635
435
13,306
123
7,093
-
873
. Excludes Buildings and Fecilities considerations.
GERALD
R.
FORD
5/19/76
DRAFT MESSAGE FOR THE PRESIDENT
Today, I have the pleasure of signing into law the Medical
Device Amendments of 1976 to the Federal Food, Drug, and
Cosmetic Act of 1938.
It is almost exactly 70 years since President Theodore Roosevelt
signed the nation's first federal food and drug legislation
designed to protect the American consumer against health threats
arising from harmful substances and deceptive practices. In
urging the passage of such legislation, he departed from his
policy of speaking softly, instead saying about as plainly and
as forcefully as it can' be said, that: "Traffic in foodstuffs
which have been debased or adulterated so as to injure health
or to deceive purchasers should be forbidden."
Since the Pure Food and Drugs Act of 1906, there have been
a number of actions to strengthen and update the structure of
protection that President Roosevelt urged upon us.
While we as a nation were able to take justifiable pride
in the laws providing for safety, honesty and efficacy in the
foods and drugs we consume, it became increasingly clear that
there remained a large, significant and growing gap in that
protective wall.
Until today, the American consumer could not be sure that a
medical device used hv his physician his hospital
2
Theodore Roosevelt had no need to ask in 1906 for legislation
concerning medical devices. For the devices used by physicians
of his day were comparatively simple. There was not much that
could go wrong with them. There were few ways they could be
used incorrectly. They stood at the edge of medicine, helpful
but not essential, and, therefore, posed no regulatory need.
By the 1960's, however, enormous advances in science and
technology moved medical devices from the edge close to the center
of the stage. Today devices are routinely implanted in our bodies.
They replace limbs, bones, tissues, even entire organs. They
permit treatment of forms of illness that can be reached in no
other way. They magnify and speed ten thousandfold the diagnostic
power of the human eye and brain.
Medical and diagnostic devices have produced what can
only be called a therapeutic revolution. In doing so, they
have also become more complex and less easily understood by those
who use them. When well designed, well made, and properly used
they support and lengthen life. If poorly designed, poorly
made, and improperly used they can threaten and impair it.
Despite the increasing importance of devices, the Food and
Drug Administration has had woefully inadequate authority to
deal with them. FDA has had no reliable way of knowing how many
devices there are, who is making them, who is selling them, what
injuries they can cause, and when a manufacturer has found it
necessary to remove them from the medical marketplace.
In addition, no device was required to be proven safe
and effective prior to marketing, no matter how critical it
might be to the person using it, and even if that use involved
implantation in his body.
Recognizing these and other deficiencies, the Administration
ordered a study of the problem in 1969 and subsequently asked
Congress to enact remedial legislation.
In its deliberations since that time, Congress benefited
greatly from the cooperation voluntarily extended by the
medical device industry which clearly saw the need for legislation
that would protect the consumer as well as the manufacturer who
refused to compromise with safety. Representatives of consumers
and health professionals also played an important role.
The Medical Device Amendments of 1976 eliminate the
deficiencies that accorded FDA "horse and buggy" authority to
deal with "laser age" problems. It is important not only in
what it will do to protect the consumer; it is also important
as a symbol for the kind of regulation that I feel is most
appropriate to government. For this law, while it does expand
the regulatory authority of an agency of the Federal government --
The Food and Drug Administration -- it does not -- as so much
regulation has -- impinge our freedom or unduly restrict
enterprise.
It does not represent another expansion of government
into affairs we might better manage ourselves. Instead, this
is an example of government doing for the individual citizen
what he or she cannot do unaided.
4
It is not government expanding because the opportunity is
there; it is government responding to a need by adding a vital
protection to the public health.
It is not government that impairs the competitive nature
of a dynamic new industry; this is government that strengthens
our competitive posture in the world by insuring medical
products of quality, safety and efficacy.
This is government action that does not further complicate
the task of professionals affected by it, but rather frees them
by permitting concentration on the patient rather than on the
possible unreliability of the tools used to treat the patient.
Finally, this is government that is not preventing the
full, productive exercise of the compassionate ingenuity that
has fueled this society for 200 years: this is an example of
government preventing threats to the public health in a way
that is fully consonant with the principles of competitive
economic development on which this nation was built.
These then are the reasons why I welcome this legislation
and applaud all who devised, and those who will enforce, it.
This legislation is a superlative example of the system working
the way those who founded this nation 200 years ago expected it
to work.
REVOLUTION
VETERANS ADMINISTRATION
OFFICE OF THE ADMINISTRATOR OF VETERANS AFFAIRS
AMERICAN
BICENTENNIAL
WASHINGTON, D.C. 20420
1776-1976
(
May 20, 1976
The Honorable
James T. Lynn
Director, Office of
Management and Budget
Washington, D. C. 20503
Dear Mr. Lynn:
This will respond to the request of the Assistant
Director for Legislative Reference for the views of the Vet-
erans Administration on the enrolled enactment of S. 510,
94th Congress, "To amend the Federal Food, Drug, and Cosmetic
Act to provide for the safety and effectiveness of medical
devices intended for human use, and for other purposes."
The measure provides for classification of all med-
ical devices intended for human use into one of three cate-
gories based on the extent of regulation necessary to assure
safety and effectiveness.
The enrolled bill sets classifications ranging from
a category of devices subject to general controls, to a
second group that must meet performance standards, to a third
classification under which devices are subject to premarket
approval. That third class represents devices that cannot
be set into the less rigorously regulated classes because
insufficient information exists with which to determine the
adequacy of general controls or standards to provide reason-
able assurance of safety and effectiveness; also these are
devices which are purported or represented to be for a use
in supporting or sustaining life or for a use of substantial
importance in preventing impairment of health or which
present a potential unreasonable risk of illness or injury.
Under the legislation, panels composed of experts
appointed by the Secretary of Health, Education, and Welfare
would submit recommendations regarding proper classification
of "old," already introduced devices; thereafter the Secre-
tary would promulgate a regulation classifying the devices.
Newly introduced devices, not substantially equivalent to
existing ones, would automatically fall within the third
class until reclassified by the Secretary. In regard to
the provisions governing the general requirement as to
class III devices of applying for premarket approval, there
is set a 180-day limit for action thereon by the Secretary.
With respect to the development and establishment
of performance standards for so-called class II devices,
the Secretary could accept offers by any person to develop
such standards, could adopt an existing performance stand-
ard, or could authorize a Federal agency to develop such
a standard. As to the Secretary's mandate to provide for
periodic evaluation of these standards, we note the language
of section 514 (a) (5) (A) of the enrolled bill authorizing
that official to "use personnel, facilities, and other
technical support available in other Federal agencies."
Persons adversely affected by a proposed standard could
require its submission to an advisory committee of experts.
Among the many other significant provisions of
the enrolled bill are measures requiring notification of
patients subject to risks or hazards presented by devices;
provision for restricting the sale, distribution, or use
of devices; and authorization for establishment of require-
ments for good manufacturing practice.
The Veterans Administration, in the administration
of far-flung medical activities, is, of course, vitally
interested in the protection of public health and safety.
We applaud the purposes of this legislation and are particu-
larly concerned with the need to protect the consumer of
medical services from unsafe and ineffective medical devices.
GERALD
The number and diversity of devices used in diagno-
sis, monitoring and treatment of patients in modern clinical
practice grows increasingly significant. Moreover, there
has been an increase in the number of firms engaged in the
manufacture and sale of these devices. Their products may
vary substantially with regard to effectiveness of perform-
ance and margin of safety.
The VA has for many years regulated the quality,
safety, and performance of prosthetic devices for amputees,
and has established performance standards for these and
other devices. We believe this program has been eminently
successful and welcome an extension of its benefits to all
medical devices.
The major features of the bill--classification, use
of performance standards, good manufacturing practices,
and reliance upon panels and advisory committees--have
attained general acceptance after years of debate. The bill
is a well conceived, thoroughly detailed document. We favor
the provisions of the enrolled bill. Therefore, I recommend
that the President approve S. 510.
Sincerely,
Deputy Administrator . in the absence of
RICHARD L. ROUDEBUSH
Administrator
3.
DEPARTMENT or COMMARCE
GENERAL COUNSEL OF THE
UNITED STATES DEPARTMENT OF COMMERCE
UNITED
AMERICA
Washington, D.C. 20230
STATES
of
MAY 18 1976
Honorable James T. Lynn
Director, Office of Management
and Budget
Washington, D. C. 20503
Attention: Assistant Director for Legislative Reference
Dear Mr. Lynn:
This is in reply to your request for the views of this Department
concerning S. 510, an enrolled enactment
"To amend the Federal Food, Drug, and Cosmetic Act
to provide for the safety and effectiveness of medical
devices intended for human use, and for other purposes, 11
to be cited as the "Medical Device Amendments of 1976. 11
The purpose of S. 510 is to provide new authority to the Secretary
of Health, Education, and Welfare to assure the safety and effective-
ness of medical devices intended for human use. It would require
premarket approval of certain medical devices and authorize estab-
lishment of performance standards for others. Also, it would
strengthen the authority of the Food and Drug Administration to
take regulatory action against hazardous or deceptive medical
devices, to prescribe good manufacturing practice regulations, to
inspect records, to register device manufacturers, and to require
maintenance of records and submission of reports concerning these
products.
This Department would have no objection to approval by the President
of S. 510.
Enactment of this legislation will not involve any increase in the
budgetary requirements of this Department.
Sincerely,
7.F.dmith General Counsel
REVOLUTION
AMERICAN
BICENTENNIAL
SIST/NT ATTORNEY GENERAL
ATIVE AFFAIRS
Department of Justice
Mashington, D.C. 20530
May 20, 1976
Honorable James T. Lynn
Director
Office of Management and Budget
Washington, D.C. 20503
Dear Mr. Lynn:
In compliance with your request, I have examined
a facsimile of the enrolled bill S. 510 "To amend
the Federal Food, Drug and Cosmetic Act to provide
for the safety and effectiveness of medical devices
intended for human use, and other purposes."
The enrolled bill, otherwise known as "The
Medical Device Amendments of 1976, is the culmination
of several years work by Congress, the Food and Drug
Administration, other Executive Departments, industry
and consumer groups. In short S. 510 establishes
classifications for devices intended for human use,
and sets out the standards for both safety and efficacy
of medical devices. At present, there is no relevant
federal law on the regulation of most devices except
to the extent the government has been able to argue
successfully that a particular item is a drug and thus
within the present Food, Drug and Cosmetic Act.
Section 515 of the enrolled bill provides, with
certain "grandfather" provisions (section 520(1))
that medical devices must prior to their introduction
into interstate commerce receive premarket approval
from the Food and Drug Administration. Devices not
receiving approval would be banned by virtue of section
516 and the enforcement sanctions of the present Food,
Drug and Cosmetic Act would be applicable, see 21 U.S.C.
331, 333.
Judicial review would be available under section
517 to anyone seeking reversal of agency action regarding
a medical device to which the person has an interest.
The enrolled bill appears to effectively solve
many problems previously associated with medical devices,
the safety and efficacy of which have been outside the
scope of the Food and Drug Administration's responsibility.
The Department of Justice has no objection to Execu-
tive approval of this bill.
Sincerely,
michael In Uhiman
Michael M. Uhlmann
Assistant Attorney General
DEPARTMENT OF THE ARMY
WASHINGTON, D.C. 20310
THE
21 May 1976
Honorable James T. Lynn
Director, Office of Management and Budget
Dear Mr. Lynn:
The Secretary of Defense has delegated responsibility to the Department
of the Army for reporting the views of the Department of Defense on
enrolled enactment S.510, 94th Congress, "To protect the public health
by amending the Federal Food, Drug, and Cosmetic Act to assure the
safety and effectiveness of medical devices. "
The Department of the Army on behalf of the Department of Defense sup-
ports the objectives of the enrolled enactment but defers to the views
of the Department of Health, Education and Welfare as to its merits.
The purpose of the act is stated in its title.
Approval of the enactment may have a minor impact on that portion of the
DOD budget used to fund medical programs; however, no funds have been
included in the budget for this item.
This report has been coordinated within the Department of Defense in
accordance with procedures prescribed by the Secretary of Defense.
Sincerely,
Martin R offmann
Secretary OF the Army
THE WHITE HOUSE
WASHINGTON
May 21, 1976
MEMORANDUM FOR:
JIM CAVANAUGH
sel
FROM:
SPENCE JOHNSON
SUBJECT:
Schedule Proposal: S. 510,
Medical Devices Act of 1976.
Attached is the schedule proposal per our conversation.
Since the President is not returning to the White House
until Thursday, Bill Nicholson has indicated there may
be some problem in getting this on his schedule. There-
fore, it may require some extra push.
Thanks.
THE WHITE HOUSE SCHEDULE PROPOSAL
WASHINGTON
DATE: May 21, 1976
FROM:
Spencer Johnson
THRU:
Jim Cannon
VIA:
Bill Nicholson
MEETING:
Signing Ceremony
DATE:
Thursday, May 27, 1976
PURPOSE:
To sign S. 510, Medical Devices Act of 1976.
FORMAT:
Rose Garden or Cabinet Room
10 minutes
Participants: Secretary David Mathews and
selected HEW staff; Members of Congress and
selected committee staff; industry repre-
sentatives.
SPEECH
MATERIAL:
Talking points to be provided by the Domestic
Council.
PRESS
COVERAGE:
Full coverage; press and photo opportunity.
STAFF:
Jim Cannon, Spencer Johnson.
RECOMMEND:
Domestic Council, Department of HEW, OMB.
BACKGROUND:
S. 510 amends the Food, Drug and Cosmetic
Act of 1962 to permit the Secretary of HEW
to protect the public from unsafe or in-
effective medical devices. The tremendous
medical technological explosion has resulted
in unknown numbers of medical devices used
in the practice of medicine for which there
is no effective means to insure safety and
effectiveness. The legislation, the first
significant amendment to the Food, Drug
and Cosmetic Act of 1962, grants the Food
and Drug Administration the authority to
respond to this vital need to protect the
public health. The measure frees professionals
to concentrate solely on the patient in pro-
viding high quality medical care, rather than
concerning themselves with the possible un-
reliability of the tools at their disposal.
APPROVE
DISAPPROVE
THE WHITE HOUSE
WASHINGTON
SIGNING CEREMONY
MEDICAL DEVICE AMENDMENTS OF 1976
(Enrolled Bill S. 510)
Friday, May 28, 1976
12:00 p.m. (10 minutes)
The Oval Office
From: Jim Cannon
I. PURPOSE
To sign into law Enrolled Bill S. 510, Medical
Device Amendments of 1976 which provides new
authority to the Secretary of Health, Education,
and Welfare to assure the safety and effective-
ness of medical devices intended for human use.
II. BACKGROUND, PARTICIPANTS, PRESS PLAN
A. Background: S. 510 would amend the Federal
Food, Drug and Cosmetic (FDC) Act of 1938
to provide the Food and Drug Administration
(FDA) in the Department of Health, Education
and Welfare (HEW) with significant new
authority to regulate the safety and effective-
ness of medical devices. The enrolled bill
is the first amendment to the FDC Act since
1938 dealing with medical devices and repre-
sents several years of work by the Executive
branch and the Congress to develop acceptable
legislation to assure that modern medical
devices are safe and effective.
B. Participants:
Secretary David Mathews
Dr. Theodore Cooper, Assistant Secretary of Health
Dr. Alexander Schmidt, Commissioner, FDA
Sylvester Jones, Intern for Secretary Mathews
- 2 -
C. Press Plan: No announcement. White House
photo opportunity.
III. TALKING POINTS
1. I am pleased to sign into law the Medical
Device Amendments of 1976 which will give
the Secretary of Health, Education and Welfare
new authority to assure safe and effective
medical devices for America's medical system.
2. These amendments will give the Food and Drug
Administration the ability to do for the
individual citizen what he or she cannot do
for themselves -- prevent the sale or use of
unsafe or ineffective medical devices.
3. The FDA faces a most difficult task that
requires determination, scientific skills,
judgement, and most of all, compassion for
the hopes and needs of our fellow man.
4. I commend the Congress, HEW, and the FDA
for their fine work and cooperation.
FOR IMMEDIATE RELEASE
MAY 28, 1976
Office of the White House Press Secretary
THE WHITE HOUSE
STATEMENT BY THE PRESIDENT
Today I have the pleasure of signing into law S. 510,
the Medical Device Amendments of 1976 to the Federal Food
Drug, and Cosmetic Act of 1938.
It is almost exactly 70 years since President Theodore
Roosevelt signed the Pure Food and Drugs Act of 1906, the
nation's first federal food and drug legislation designed
to protect the American consumer against health threats
arising from harmful substances and deceptive practices.
Since then, there have been a number of actions to
strengthen and update the structure of protection sought
by President Roosevelt.
While we as a nation were able to take justifiable
pride in the laws providing for safety, honesty and
efficacy in the foods and drugs we consume, it became
increasingly clear that there remained a large, significant
and growing gap in that security.
Until today, the American consumer could not be sure
that a medical device used by his physician, his hospital,
or himself was as safe and effective as it could or should
be.
In 1906, President Roosevelt had no need to ask for
legislation concerning medical devices: for the devices
used by physicians of his day were comparatively simple.
They stood at the edge of medicine, helpful but not essential.
and, therefore, posed no regulatory need.
By the 1960's, however, enormous advances in science
and technology moved medical devices from the edge close
to the center of the stage. Today devices are routinely
implanted in our bodies. They replace limbs, bones,
tissues even entire organs. They permit treatment of
forms of illness that can be accomplished in no other way.
They magnify and speed ten thousandfold the diagnostic
power of the human eye and brain.
Medical and diagnostic devices have produced a thera-
peutic revolution, but in doing so, they have also become
more complex and less easily understood by those who use
them. When well designed, well made, and properly used
they support and lengthen life. If poorly designed, poorly
made, and improperly used they can threaten and impair it.
Despite the increasing importance of devices, the Food
and Drug Administration has had inadequate authority to deal
with them. FDA has had no reliable way of knowing how many
devices there are, who is making them, who is selling them
what risks to health and life they may present, and when a
manufacturer has found it necessary to remove them from
the medical marketplace.
more
2
In addition, no device was required to be proven safe
and effective prior to marketing. no matter how crucial it
might be to the person using it, even if that use involved
implantation in his body.
Recognizing these and other deficiencies the
Administration ordered a study of the problem in 1969
and subsequently asked Congress to enact remedial legislation.
In its deliberations since that time, Congress benefited
greatly from the cooperation voluntarily extended by the
medical device industry who clearly saw the need for legis.
lation that would protect the consumer as well as the
manufacturer who refused to compromise with safety.
Representatives of consumers and health professionals also
played an important role.
The Medical Device Amendments of 1976 eliminate the
deficiencies that accorded FDA "horse and buggy authority
to deal with Plaser age" problems. It is important not
only in what it will do to protect the consumer it is also
important as a symbol for the kind of regulation that I feel
is most appropriate to government. It does not represent
another expansion of government into affairs we might better
manage ourselves. Instead, this is an example of government
doing for the individual citizen what he or she cannot do
unaided.
I welcome this legislation and commend the FDA who
identified the need, cooperated in its development, and
finally, will be entrusted with its enforcement.
This agency daily faces a most difficult task
preventing threats to the public health in a way that is
not onerous, but fully consonant with the principles of
competitive economic development on which this nation was
built. It is a task that requires determination, scientific
skill, judgment and most of all, compassion for the hopes
and needs of our fellow man. Dr. Alexander M. Schmidt,
Commissioner of Food and Drugs. has effectively taken
on the job of assuring that the hope and expectations
of the consumer for life-giving drugs and devices are not
false promises.
I reaffirm my support for the fine work of the Food
and Drug Administration and the job ahead.
#
#
#
FOR IMMEDIATE RELEASE
MAY 28, 1976
Office of the White House Press Secretary
THE WHITE HOUSE
STATEMENT BY THE PRESIDENT
Today, I have the pleasure of signing into law S. 510,
the Medical Device Amendments of 1976 to the Federal Food
Drug, and Cosmetic Act of 1938.
It is almost exactly 70 years since President Theodore
Roosevelt signed the Pure Food and Drugs Act of 1906, the
nation's first federal food and drug legislation designed
to protect the American consumer against health threats
arising from harmful substances and deceptive practices.
Since then, there have been a number of actions to
strengthen and update the structure of protection sought
by President Roosevelt.
While we as a nation were able to take justifiable
pride in the laws providing for safety, honesty and
efficacy in the foods and drugs we consume, it became
increasingly clear that there remained a large, significant
and growing gap in that security.
Until today, the American consumer could not be sure
that a medical device used by his physician, his hospital,
or himself was as safe and effective as it could or should
be.
In 1906, President Roosevelt had no need to ask for
legislation concerning medical devices; for the devices
used by physicians of his day were comparatively simple.
They stood at the edge of medicine, helpful but not essential.
and, therefore, posed no regulatory need.
By the 1960's, however, enormous advances in science
and technology moved medical devices from the edge close
to the center of the stage. Today devices are routinely
implanted in our bodies. They replace limbs, bones,
tissues even entire organs. They permit treatment of
forms of illness that can be accomplished in no other way.
They magnify and speed ten thousandfold the diagnostic
power of the human eye and brain.
Medical and diagnostic devices have produced a thera-
peutic revolution, but in doing so, they have also become
more complex and less easily understood by those who use
them. When well designed, well made, and properly used
they support and lengthen life. If poorly designed, poorly
made, and improperly used they can threaten and impair it.
Despite the increasing importance of devices, the Food
and Drug Administration has had inadequate authority to deal
with them. FDA has had no reliable way of knowing how many
devices there are, who is making them, who is selling them
what risks to health and life they may present, and when a
manufacturer has found it necessary to remove them from
the medical marketplace.
more
2
In addition, no device was required to be proven safe
and effective prior to marketing, no matter how crucial it
might be to the person using it, even if that use involved
implantation in his body.
Recognizing these and other deficiencies the
Administration ordered a study of the problem in 1969
and subsequently asked Congress to enact remedial legislation.
In its deliberations since that time, Congress benefited
greatly from the cooperation voluntarily extended by the
medical device industry who clearly saw the need for legis
lation that would protect the consumer as well as the
manufacturer who refused to compromise with safety.
Representatives of consumers and health professionals also
played an important role.
The Medical Device Amendments of 1976 eliminate the
deficiencies that accorded FDA "horse and buggy" authority
to deal with laser age' problems. It is important not
only in what it will do to protect the consumer it is also
important as a symbol for the kind of regulation that I feel
is most appropriate to government. It does not represent
another expansion of government into affairs we might better
manage ourselves. Instead, this is an example of government
doing for the individual citizen what he or she cannot do
unaided.
I welcome this legislation and commend the FDA who
identified the need cooperated in its development, and
finally will be entrusted with its enforcement.
This agency daily faces a most difficult task
preventing threats to the public health in a way that is
not onerous, but fully consonant with the principles of
competitive economic development on which this nation was
built. It is a task that requires determination, scientific
skill, judgment and most of all, compassion for the hopes
and needs of our fellow man. Dr. Alexander M. Schmidt,
Commissioner of Food and Drugs, has effectively taken
on the job of assuring that the hope and expectations
of the consumer for giving drugs and devices are not
false promises.
I reaffirm my support for the fine work of the Food
and Drug Administration and the job ahead.
#
#
#
June 9, 1976
Dear Miss Glisson:
As you know, I signed S. 510, the
Medical Device Amendments of 1976, on
May 28. Because of your efforts on
behalf of this legislation, I am
pleased to send you a ceremonial pen
to mark the bill becoming Public Law
94-295.
Sincerely,
Miss Johnne Glisson
Research Assistant
Subcommittee on Health
and the Environment
Committee on Interstate
and Foreign Commerce
House of Representatives
Washington, D. C. 20515
CC: Spencer Johnson -FYI
GRF:MLF:JEB:VO:emu
FORD & LIBRARY GERALD
June 9, 1976
Dear Mr. Greene:
As you know, I signed S. 510, the
Medical Device Amendments of 1976, on
May 28. Because of your efforts on
behalf of this legislation, I am
pleased to send you a ceremonial pen
to mark the bill becoming Public Law
94-295.
Sincerely,
Mr. H. Thomas Greene
Associate Counsel
Committee on Interstate
and Foreign Commerce
House of Representatives
Washington, D. C. 20515
CC: Spencer Johnson - FYI
GRF:MLF:JEB:VO:emu
FORD LIBRARY i GERALD
June 9, 1976
Dear Mr. Meade:
As you know, I signed S. 510, the
Medical Device Amendments of 1976, on
May 28. Because of your efforts on
behalf of this legislation, I am
pleased to send you a ceremonial pen
to mark the bill becoming Public Law
94-295.
Sincerely,
Mr. David E. Meade
Assistant Counsel
Office of the Legislative Counsel
House of Representatives
Washington, D. c. 20515
cc: Spencer Johnson, FYI
GRF:MLF:JEB:VO:emu
FORD LIBRARY & GERALD
June 9, 1976
Dear Mr. Lawton:
As you know, I signed S. 510, the
Medical Device Amendments of 1976, on
May 28, Because of your efforts on
behalf of this legislation, I am
pleased to send you a ceremonial pen
to mark the bill becoming Public Law
94-295.
Sincerely,
Mr. Stephan Lawton
Counsel
Subcommittee on Health
and the Environment
Committee on Interstate
and Foreign Commerce
House of Representatives
Washington, D. C. 20515
CC: Spencer Johnson - FYI
GRF:MLF:JEB:VO:emu
FORD LIBRARY Y GERALD
June 9, 1976
Dear Dick:
As you know, I have signed S. 510, the
Medical Device Amendments of 1976. Be-
cause of your special interest in this
legislation, I am pleased to send you
a ceremonial pen to mark the bill
becoming Public Law 94-295 on May 28.
Sincerely,
The Honorable Richard S. Schweiker
United States Senate
Washington, D. c. 20510
CC: Spencer Johnson, FYI
GRF:MLF:JEB:VO:emu
GERALD
FORD LIBRARI j
June 9, 1976
Dear Ted:
As you know, I have signed S. 510, the
Medical Device Amendments of 1976. Be-
cause of your special interest in this
legislation, I am pleased to send you
a ceremonial pen to mark the bill
becoming Public Law 94-295 on May 28.
Sincerely,
The Honorable Edward H. Kennedy
United States Senate
Washington, D. C. 20510
CC: Spencer Johnson, FYI
GRF:MLF:JEB:VO:emu
FORD LIBRARY is GERALD
June 9, 1976
Dear Tim:
As you know, I have signed S. 510, the
Medical Device Amendments of 1976. Be-
cause of your special interest in this
legislation, I am pleased to send you
a ceremonial pen to mark the bill
becoming Public Law 94-295 on May 28.
Sincerely,
The Honorable Tim Lee Carter
House of Representatives
Washington, D. C. 20515
CC: Spencer Johnson, FYI
GRF:MLF:JEB:VO:emu
FORD LIBRARY is CERALD
June 9, 1976
Dear Paul:
As you know, I have signed S. 510, the
Medical Device Amendments of 1976. Be-
cause of your special interest in this
legislation, I am pleased to send you
a ceremonial pen to mark the bill
becoming Public Law 94-295 on May 28.
Sincerely,
The Honorable Paul G. Rogers
House of Representatives
Washington, D. c. 20515
cc: Spencer Johnson, FYI
GRF:MLF:JEB:VO:emu
FORD
GERALD R. LIBRARY
HEALTH.
OF
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
OFFICE OF THE SECRETARY
U.S.A
WASHINGTON, D.C. 20201
June 23, 1976
Mr. Spencer C. Johnson
Associate Director for Health,
Social Security, and Welfare
The Domestic Council
Washington, D. C. 20501
Dear Mr. Johnson:
Thank you for sending me a copy of the photograph taken at
the signing of the Medical Device Amendments of 1976 at the
White House. Dr. Mathews was very accurate in saying that
I am "delighted" to have a copy of the photograph with
President Ford signing the Amendments.
I can assure you that it was a great pleasure to meet
President Ford. It was an event that will always be remem-
bered as a highlight of my summer in Washington, D. C. with
the Department of Health, Education, and Welfare.
Sincerely,
Sylvester Jones
Student Assistant
CC: Secretary Mathews
HEALTH. EDUCATION
THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE
DEPAR ONV OF
WASHINGTON, D. C. 20201
U.S.A.
The Honorable Spencer C. Johnson
Associate Director
The Domestic Council
Washington, D.C. 20500
Dear Spence:
Thank you for sending me copies of the photo-
graph taken at the signing of the Medical Device
Amendments of 1976. Sylvester Jones is delighted
to have a copy also.
CC: Mr. Sylvester Jones
Spencer Johnson
June 25, 1976
Dear Bill:
This is in further reply to your May 27
letter to the President concerning the
Medical Device Amendments and the possible
effect of this legislation on ophthalmole-
gists in your Districe.
I understand you have written a apparate
letter on this matter to Commissioner
Schmidt of the Food and Drug Administra-
tion, and that he is preparing a detailed
reply which you should receive shortly.
I hope the information he will furnish
will be helpful to you. If you have
additional questions, please let ne know.
with kindest regards,
Sincerely,
Charles Leppart, Jr.
Deputy Assistant
to the President
The Nonorable William N. Ketchum
House of Representatives
Washington, D.C. 20515
bee: James Cannon (atta; Spencer Johnson) --- FYI
CL:HEW:DOM.COUNCIL:JEB:jem
FORD LIBRARY & GERALD
HEALTH.
OF
APPLICA
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
OFFICE OF THE SECRETARY
U.S.A.
WASHINGTON, D.C. 20201
1 2 JUL 1976
TO:
Spencer Johnson
FROM: Gene Haislip
SUBJECT: Recognition for Major Contribution to the Enactment
of Medical Devices Legislation
Attached is a list of persons whose efforts were in large
measure responsible for the passage of P.L. 94-295, a major
piece of legislation establishing necessary controls over
the marketing of medical devices. The list was prepared at
my request by FDA with the instruction that only those persons
who had played a leading role were to be included. I suggest
that each of them receive a Presidential pen and suitable
expression of appreciation for their contribution to the
enactment of this law.
Gene
LIST OF INDIVIDUALS TO RECEIVE PENS USED
IN SIGNING THE MEDICAL DEVICE BILL INTO LAW
Members of Congress
Jacob K. Javits, Ranking Minority Member
Committee on Labor and Public Welfare
United States Senate
Edward M. Kennedy, Chairman
Subcommittee on Health
Committee on Labor and Public Welfare
United States Senate
Paul G. Rogers, Chairman
Subcommittee on Health and the Environment
Committee on Interstate and Foreign Commerce
House of Representatives
Tim Lee Carter, Ranking Minority Member
Subcommittee on Health and the Environment
Committee on Interstate and Foreign Commerce
House of Representatives
Department of Health, Education, and Welfare
Theodore Cooper, M.D., Assistant Secretary for Health
Congressional Staff Members
Stephan E. Lawton, Counsel
Subcommittee on Health and the Environment
Committee on Interstate and Foreign Commerce
House of Representatives
H. Thomas Greene, Associate Counsel
Minority Staff
Committee on Interstate and Foreign Commerce
House of Representatives
Lowrence Horowitz, M.D.
Professional Staff Member
Subcommittee on Health
Committee on Labor and Public Welfare
United States Senate
PORD LIBRARY & GERALD
- 2 -
Congressional Staff Members (Continued)
Jay Cutler, Minority Counsel
Subcommittee on Health
Committee on Labor and Public Welfare
United States Senate
Alan Fox, Staff Assistant
Subcommittee on Health
Committee on Labor and Public Welfare
United States Senate
Food and Drug Administration Staff Members
Richard A. Merrill, Chief Counsel
Linda Horton, Associate Chief Counsel for
Medical Devices and Diagnostic Products
David R. Link, Director, Bureau of Medical
Devices and Diagnostic Products
*One for the Food and Drug Administration
FORD LIBRARY is GERALD
medical deview
NOTICES
28817
National Bureau of Standards
Drug and Cosmetic Act (21 U.S.C. 360j)
4. Two of the members shall be repre-
FEDERAL INFORMATION PROCESSING
submissions by September 13, 1976.
sentative of the interests of the general
STANDARDS TASK GROUP 13 WORK-
Since December 1973, FDA has been
public.
LOAD DEFINITION AND BENCHMARK-
involved in the development of current
To be considered for appointment to
ING
good manufacturing practice regulations
this advisory committee, each nomination
Meeting
for medical devices. A preliminary draft
must be received on or before September
of a proposed current good manufactur-
13, 1976 and must be accompanied by a
Pursuant to the Federal Advisory Com-
ing practice regulation was made avail-
curriculum vitae that includes the
mittee Act, 5 U.S.C. App. I (Supp. IV,
able to the public by notice of availabil-
nominee's current employment, profes-
1974), notice is hereby given that the
ity published in the FEDERAL REGISTER'Of
sional affiliations, and educational and
Federal Information Processing Stand-
August 8, 1975 (40 FR 33482). A subse-
experience background, if any, with re-
ards Task Group 13 (FIPS TG-13),
quent notice published in the FEDERAL
spect to medical devices. Additionally,
Workload Definition and Benchmark-
REGISTER of October 9, 1975 (40 FR
each nomination must affirmatively state
ing," will hold a meeting from 10 a.m. to
47530)) announced four public meet-
that the nominee is aware of the nomina-
4 p.m. on Wednesday, August 18, 1976
ings that were held across the coun-
tion, is interested in participating in the
in Room B-255, Building 225, of the Na-
try to give interested parties the oppor-
mission of the current good manufactur-
tional Bureau of Standards at Gaithers-
tunity to present data, information, and
ing practice advisory committee, and
burg, Maryland.
views concerning the draft current good
indicate any areas of possible conflict of
The purpose of this meeting is to review
manufacturing practice regulations.
interest.
FIPS TG-13 accomplishments to date
These meetings were held in November
Nominations are solicited from con-
and to define future FIPS TG-13 task
1975 in cooperation with various district
sumer, industry, government, health
activities.
offices of FDA. Based upon the infor-
professional organizations, and the pub-
The public will be permitted to attend,
mation derived from these meetings and
lic. It is recommended that representa-
to file written statements, and, to the
numerous comments on the draft docu-
tives from each interest group develop a
extent that time permits, to present oral
ment, significant alterations have been
list of nominees acceptable to the con-
statements. Persons planning to attend
made to the original draft.
stituent organizations making up a
should notify the Acting Executive Sec-
On May 28, 1976, the Medical Device
particular interest group. The Commis-
retary, Mr. Arthur F. Chantker, Institute
Amendments of 1976 (Pub. L. 94-295)
sioner will appoint as members those
for Computer Sciences and Technology,
were enacted into law, amending the
nominecs who are most representative of
National Bureau of Standards, Washing-
Federal Food, Drug, and Cosmetic Act
an interest group to serve on the advisory
ton, D.C. 20234 (Phone-301-921-3485).
(21 S.C. 201 et seq.). Section 520(f) of
committee.
Dated: July 7, 1976.
the act provides the agency with author-
Interested persons are invited to sub-
ity to develop and promulgate regulations
ERNEST AMBLER,
mit names of nominees and accompany-
requiring that methods used in, and the
Acting Director.
ing information to:
facilities and controls used for the man-
[FR Doc.76-20117 Filed 7-12-76;8:45 am]
ufacture, packing. storage, and installa-
Food and Drug Administration, Bureau of
tion of medical devices conform to cur-
Medical Devices and Diagnostic Products,
Division of Compliance (HFK-123), 8757
DEPARTMENT OF HEALTH,
rent good manufacturing practice. These
Georgia Ave., Silver Spring, MD 20910.
EDUCATION, AND WELFARE
regulations are designed to assure that
devices will be safe and effective and
Dated: July 6, 1976.
Office of Education
otherwise in compliance with the act.
WILLIAM F. RANDOLPH,
ADVISORY COUNCIL ON
Under section 520(f) (3) of the act, the
Acting Associate Commissioner
ENVIRONMENTAL EDUCATION
Commissioner of Food and Drugs must
for Compliance.
establish an advisory committee for the
Meeting; Amendment
purpose of advising and making recom-
[PR Doc.76-20184 Filed 7-12-76;8:45 am]
In FR oc.76-18397 appearing at page
mendations on these regulations. Ad-
25922 in the FEDERAL REGISTER of June 23,
ditionally, under this provision, the Com-
ADVISORY COMMITTEES
1976, the first paragraph is amended to
missioner is authorized to request
include a meeting of the Proposal Evalu-
recommendations from the advisory com-
Notice of Meetings
ation Criteria work group to be held on
mittee on any petitions submitted re-
Correction
July 20-21, 1976 from 9:00 a.m. to 5:30
questing exemptions or variances from
p.m. in Room 2004, 400 Maryland Avenue,
good manufacturing practice require-
In FR Doc. 76-17818 appearing in the
S.W., Washington, D.C. for the purpose
ments.
issue of Friday, June 18, 1976, on page
of preparing a draft report on their find-
In the near future, the agency intends
24750, the fourth line in the second col-
ings.
to publish in the FEDERAL REGISTER a pro-
umn should read "vice; hyperthermia
posed good manufacturing practice regu-
device; mechanical cardiac resuscita-
Dated: July 9, 1976.
lation for medical devices. The current
tor;".
WALTER J. BOGAN, Jr.,
good manufacturing practice advisory
Director, Office of
committee, when appointed, will review
Public Health Service
Environmental Education.
and comment on the proposed current
TEXAS
good manufacturing practice regulations
[FR Doc.76-20385 Filed 7-12-76; am]
as well as on the comments received as a
Intention to Redesignate Professional
result of the proposal.
Standards Review Areas
Food and Drug Administration
As required by section 520(f) of the
Notice is hereby given that, pursuant
act the advisory committee shall be com-
to the order of the United States District
ADVISORY COMMITTEE FOR MEDICAL DE-
posed of nine members selected from
Court in the case of Texas Medical Asso-
VICES CURRENT GOOD MANUFACTUR-
ING PRACTICE REGULATIONS
different interest groups as follows:
siation et al V. Weinberger (U.S.D.C.,
1. Three of the members shall be ap-
W.D. of Texas, No. A-74-CA-108, Janu-
Request for Nominations for Members
pointed from persons who are officers or
asy 9, 1976), and in the light of the with-
The Food and Drug Administration
employees of any State or local govern-
drawal of the Government's appeal from
(FDA) describes the current status of
ment or of the Federal Government;
that order, the Department of Health,
current good manufacturing practice
2. Two of the members shall be ap-
Education, and Welfare (the Depart-
regulations and invites the submission of
pointed from persons who are repre-
ment) will undertake appropriate proce-
nominations for membership to the Ad-
sentative of interests of the device manu-
dures to redesignate Professional Stand-
visory Committee for Current Good
facturing industry;
ards Review Organisation (PSRO) areas
Manufacturing Practice Regulations in
3. Two of the members shall be ap-
in the State of Texas in accord with sec-
pointed from persons who are repre-
tion 1152(a) of the Social Security Act
accordance with the requirements of
sentative of the interests of physicians
(42 U.S.C. 1320(1) and 42. CFR 101.1 et
section 520(f) of the Federal Food,
and other health professionals;
seq.
&
FEDERAL REGISTER, VOL. 41, NO. 135-TUESDAY, JULY 13, 1976
GERALD
LIBRARY
28818
NOTICES
The District Court Order set aside the
Texas, but in other States, as discussed
material; to certify that true copies are
nine PSRO areas designated in Texas
in the preamble to the regulations (39
true copies of the entire file; to certify
under the Department's regulations (42
FR 10206, 3/18/74).
the complete original record; to certify
CFR 101.48) and remanded the case to
II.
the nonexistence of records on file; and
the Secretary to perform his statutory
authority to cause the HEW Seal to be
function of designating appropriate
The specific procedures which the De-
affixed to such certifications (34 FR
PSRO areas in Texas, without "inhibit-
partment will follow in redesignating
18049-50, dated November 7, 1969). The
ing external influences" from Congress.
PSRO areas in Texas pursuant to the
Commissioner was also authorized at
The United States filed a Notice of Ap-
judgment of the court will be set out in a
such time to cause the HEW Seal to be
peal in this case to the United States
notice to be published in the FEDERAL
affixed or impressed to agreements,
Court of Appeals for the Fifth Circuit
REGISTER in the near future. These pro-
awards, citations, diplomas, and similar
on March 9, 1976. After further consid-
cedures will enable the Secretary to take
documents. The redelegation by the As-
eration of the need to expedite the es-
into consideration the criteria estab-
sistant Secretary of certification au-
tablishment of the Professional Stand-
lished under 42 CFR 101.2 and to comply
thorities did not rescind previous further
ards Review program in Texas and, in
with the District Court's suggestion that
redelegations of authority made by the
light of the considerable delay that the
HEW develop and preserve a "full-scale
Commissioner. The Commissioner pre-
completion of the appeal process would
administrative record to remove any
viously further redelegated these au-
entail, the Secretary of Health, Educa-
doubts about the true basis of its forth-
thorities (except authority to certify
tion, and Welfare requested the Depart-
coming action."
that true copies are true copies of the
ment of Justice not to pursue the Appeal
The Department also plans to conduct
entire file, and authority to certify the
and to withdraw the Notice of Appeal.
an informal secret ballot poll of all doc-
complete original record) to appropriate
The Department of Justice has agreed
tors of medicine or osteopathy engaged
SSA positions, as set forth in 33 FR 2613-
with this recommendation and has taken
in active practice in Texas to ascertain
14, dated February 6, 1968; and 34 FR
appropriate action to withdraw the ap-
whether they favor the designation of
13046-47, dated August 12, 1969. Sub-
peal.
Texas PSRO areas on a local or statewide
sequent to the Assistant Secretary's re-
I.
basis. Physicians engaged in active prac-
delegation of November 7, 1969, the Com-
tice in Texas will be advised further by
missioner made additional further re-
The Department's decision should not
the Department of the detailed proce-
delegations to SSA positions, as set forth
be read as indicating approval of or
dures for the conduct of this poll. This
in 37 FR 10602-3, dated May 25, 1972:
agreement with either the factual or le-
poll will be purely advisory to the Secre-
38 FR 21681, dated August 10, 1973; and
gal conclusions of the District Court. The
tary in connection with the process of
40 FR 25616, dated June 17, 1975. These
Department continues to believe that
rèdesignating areas and will not con-
further redelegations did not include au-
the District Court's legal conclusion was
stitute the poll required under section
thority to certify the complete original
clearly erroneous in ignoring the existing
1152(g) of the Social Security Act (sec-
record.
administrative record which contained
tion 105 of Pub. L. 94-182).
I. Notice is hereby given that the Com-
the basis for the Secretary's decision
Dated: July 8, 1976.
missioner has rescinded all prior further
(Camp V. Pitts, 411 U.S. 138, (1973)).
redelegations of the subject authorities
Moreover, it is our view that the District
DAVID MATHEWS,
to SSA positions.
Court's conclusion that "agency action is
Secretary.
II. Notice is also hereby given that the
invalid if based, even in part, on pres-
[FR Doc.76-20178 Filed 7-12-76;8:45 am]
Commissioner has concurrently further
sures emanating from Congressional
redelegated the following authorities to
sources" is incorrect since Congressional
the SSA positions specified below:
input is entirely appropriate in the quasi-
Social Security Administration
1. Authority to certify true copies of
legislative function of rulemaking (see
REDELEGATIONS OF AUTHORITY
Angel V. Butz, 487 U.S. 967). Finally, the
any books, records, papers or other doc-
District Court's opinion fails to recog-
Various Certifications and To Cause the
uments on file;
nize the appropriate role of Congress in
Department Seal To Be Affixed or Im-
2. Authority to certify extracts from
overseeing the "application, administra-
pressed
material on file;
tion, and execution" of laws (2 U.S.C.
The Assistant Secretary for Adminis-
3. Authority to certify that true copies
190(d)) and further fails to follow the
tration and Mangement of the Depart-
are true copies of the entire record on
single case which it cited as precedent,
ment of Health, Education, and Welfare
file;
D.C. Federation of Citizens V. Volpe, 459
had redelegated to the Commissioner of
4. Authority to certify the complete
F. 2d 1231 (D.C. Cir. 1971). In that case
Social Security (the Commissioner), with
original record on file;
the court plainly focused on irrelevant
authority to further redelegate, authority
5. Authority to certify that particular
Congressional pressure as being an un-
to certify true copies of any books, rec-
records are not on file; and
due influence on administrative action
ords, papers or other documents on file
(459 F. 2d at 1248), which is clearly dis-
6. Authority to cause the HEW Seal to
within the Social Security Administra-
tinguished from the Congressional at-
be affixed or impressed to those certifica-
tempts in this case to call attention to
tion (SSA); to certify extracts from such
tions identified above.
the legislative history of the statute in-
Delegates
Scope of authority
volved, which the Courts have always
1. Deputy Commissioner
1 and 2. SSA-wide.
considered highly relevant to the process
2. Associate Commissioner for Management
of statutory construction.
and Administration, and Deputy Asso-
The factual conclusion of the District
clate Commissioner for Management
Court that the Secretary and HEW Ad-
and Administration.
ministrators were, in fact, influenced by
3. Associate commissioners and deputy as-
8. Office or Bureauwide.
the "financial leverage" of the Congres-
sociate commissioners; Director, Bu-
sional sources of the alleged "pressure"
reau of Health Insurance; Director and
is plainly wrong, since the "source" ob-
Deputy Director, Bureau of Hearings
viously had no power to control the ap-
and Appeals; and the Director, Office of
propriation of funds to HEW. The De-
Advanced Systems.
4. Those headquarters component head po-
4. Componentwide.
partment's decision to require local areas
sitions and deputy component head
in Texas was based on the Department's
positions at the 1st organization level
guidelines for designation of areas, as
below the positions specified in items
published in regulations (42 CFR 101.2).
2 and 3 above.
This was demonstrated by the adherence
5. Regional commissioners and deputy re-
5. Cases within the jurisdiction of regional
of the Department to the guidelines in
gional commissioners, Office of Program
components of the Office of Program
the designation of areas, not only in
Operations.
Operations.
FEDERAL REGISTER, VOL. 41, NO, 135-TUESDAY, JULY 13, 1976
NOTICES
28819
Delegates
Scope of authority
6. Assistant Bureau Director, Operations,
6. Cases within the jurisdiction of compo-
and Deputy Assistant Bureau Director,
nents reporting to the Assistant Bureau
Operations, Bureau of Data Processing,
Director, Operations, Bureau of Data
Office of Program Operations.
Processing, Office of Program Opera-
tions.
7. Director and Deputy Director, Division of
7. Divisionwide.
Adjustment Operations; Director and
Deputy Director, Division of Claims
Operations; Director and Deputy Direc-
tor, Division of Registration Opera-
tions; Director and Deputy Director,
Division of Earnings Operations; and
Director and Deputy Director, Division
of Health Insurance Operations; Bu-
reau of Data Processing, Office of Pro-
gram Operations.
8. Assistant Bureau Director, Disability Op-
8. Cases within the jurisdiction of compo-
erations, and Deputy Assistant Bureau
nents reporting to the Assistant Bu-
Director, Disability Operations, Bureau
reau Director, Disability Operations,
of Disability Insurance, Office of Pro-
Bureau of Disability Insurance, Office
gram Operations.
of Program Operations.
9. Assistant Bureau Director, Systems and
9. Cases within the jurisdiction of compo-
Methods, and Deputy Assistant Bureau
nents reporting to the Assistant Bu-
Director, Systems and Methods, Bureau
reau Director, Systems and Methods,
of Retirement and Survivors Insurance,
Bureau of Retirement and Survivors
Office of Program Operations.
Insurance, Office of Program Opera-
tions.
10. Assistant Bureau Director, Technical Pol-
10. Cases within the jurisdiction of compo-
icy, and Deputy Assistant Bureau DI-
nents reporting to the Assistant Bu-
rector, Technical Policy, Bureau of
reau Director, Technical Policy, Bu-
Health Insurance.
reau of Health Insurance.
11. Chief, Civil Actions Branch, Division of
11. Cases within the jurisdiction of the Civil
Appeals Operations, Bureau of Hearings
Actions Branch, Division of Appeals
and Appeals.
Operations, Bureau of Hearings and
Appeals.
12. Regional representatives and deputy re-
12. Cases within the jurisdiction of regional
gional representatives, Health Insur-
offices of the Bureau of Health Insur-
ance.
ance.
13. Regional chief administrative law judges,
13. Cases within the jurisdiction of regional
Bureau of Hearings and Appeals.
offices of the Bureau of Hearings and
Appeals.
14. Directors, SSA program service centers,
14. Cases within the jurisdiction of 88A pro-
Bureau of Retirement and Survivors
gram service centers, Bureau of Retire-
Insurance, Office of Program Opera-
ment and Survivors Insurance, Office
tions.
of Program Operations.
15. Program review officers, Office of Quality
15. Cases within the jurisdiction of program
Assurance, Office of Management and
review offices, Office of Management
Administration.
and Administration.
16. Directors and deputy directors, data op-
16. Cases within the jurisdiction of data
erations centers, Bureau of Data Proc-
operations centers, Bureau of Data
essing, Office of Program Operations.
Processing, Office of Program Opera-
tions.
III. Notice is also hereby given that the Commissioner has rescinded all previous
further redelegations to SSA positions of authority to cause the HEW Seal to be
affixed or impressed to agreements; awards; citations; diplomas; or similar docu-
ments, and concurrently further redelegated such authority to the SSA positions
specified below:
Delegates
Scope of authority
1. Deputy Commissioner
1 and 2. SSA-wide.
2. Associate Commissioner for Management
and Administration, and Deputy Asso-
clate Commissioner for Management
and Administration.
3. Associate Commissioners and deputy as-
3. Office or Bureauwide.
sociate commissioners; Director, Bu-
reau of Health Insurance; Director and
Deputy Director, Bureau of Hearings
and Appeals; and the Director, Office of
Advanced Systems.
4. Those headquarters component head po-
4. Componentwide.
sitions and deputy component head po-
sitions at the first organizational level
below the positions specified in items
2 and 3 above.
5. Regional commissioners and deputy re-
5. Cases within the jurisdiction of regional
gional commissioners, Office of Program
components of the Office of Program
Operations.
Operations.
FORD
6. Regional representatives and deputy re-
6. Cases within the jurisdiction of regional
"If
gional representatives, Health Insur-
offices of the Bureau of Health Insur-
ance.
ance.
GERALD
LIBRARY
FEDERAL REGISTER, VOL. 41, NO. 135-TUESDAY, JULY 13, 1976
28820
NOTICES
Delegates
Scope of authority
Committee Act of 1972 (P.L. 92-463), I,
7. Regional chief administrative law judges,
7. Cases within the jurisdiction of regional
Constance B. Newman, am appointing
Bureau of Hearings and Appeals.
offices of the Bureau of Hearings and
the following persons to servè terms on
Appeals.
the National Mobile Home Advisory
8. Directors, SSA program service centers,
8. Cases within the jurisdiction of SSA
Council:
Bureau of Retirement and Survivors
program service centers, Bureau of Re-
To complete terms expiring December
Insurance, Office of Program Opera-
tirement and Survivors Insurance, Of-
31, 1976.
tions.
fice of Program Operations.
GOVERNMENT OFFICIALS
9. Program review officers, Office of Quality
9. Cases within the jurisdiction of program
Assurance, Office of Management and
review offices, Office of Management
William E. Dell, Assistant to the Director, De-
Administration.
and Administration.
partment of Labor nad Industries, Seattle,
10. Directors and deputy directors, data op-
10. Cases within the jurisdiction of data
Washington.
erations centers, Bureau of Data Proc-
operations centers, Bureau of Data
Marion B. Robinson, Director, Division of In-
essing, Office of Program Operations.
spection Services, Columbia, South Caro-
Processing, Office of Program Opera-
lina.
tions.
COMMUNITY AND CONSUMER REPRESENTATIVES
IV. Any actions heretofore taken by the incumbents of the positions specified in
sections II and III above which, in effect, involve the exercise of authority further
Herbert F. Hugo, President, Golden State Mo-
redelegated by this document, are hereby affirmed and ratified.
bilhome Owners League, Garden Grove,
V. The rescissions and further redelegations specified in sections I through III
California.
above are effective July 13, 1976. The incumbents of those positions further redele-
INDUSTRY
gated the subject authorities may not themselves redelegate such authorities.
Bill Novak, President, Gallatin Homes Cor-
Dated: July 6, 1976.
poration, Belgrade, Montana.
J. B. CARDWELL,
To replace members whose terms ex-
Commissioner of Social Security.
pired April 30, 1976, and who will serve
[FR Doc.76-20131 Filed 7-12-76;8:45 am]
terms expiring December 31, 1977:
GOVERNMENT OFFICIALS
DEPARTMENT OF HOUSING AND
Additionally, at this time, as a result
C. Sutton Mullen, Administrator, Industrial-
URBAN DEVELOPMENT
of the resignation of two members and
ized Building Law, State Corporation Com-
the deaths of two others, there are four
mission, Richmond, Virginia.
Assistant Secretary for Consumer Affairs
vacancies on the Council. These four
Kenneth E. Meiser, Public Advocate, Division
and Regulatory Functions
terms expire on December 31, 1976. The
of Public Interest Advocacy, Department of
Public Advocate, Trenton, New Jersey.
[Docket No. N-76-564]
vacancies were for: one consumer repre-
Richard Bullock, Chief, Mobile Home Section,
NATIONAL MOBILE HOME ADVISORY
sentative, one industry representative
Department of Labor and Human Rela-
COUNCIL
and two government representatives. Ap-
tions, Madison, Wisconsin.
pointments for the four vacant terms
Fred H. Jolly, Director, Division of Environ-
Establishment
were made from those persons nominated
mental Health Services, State Department
The National Mobile Home Construc-
in 1975.
of Health, Lincoln, Nebraska.
tion and Safety Act of 1974 (Title VI of
Nominations for the 12 expiring terms
COMMUNITY AND CONSUMER REPRESENTATIVES
the Housing and Community Develop-
were requested at 41 FR 3500 on Janu-
Margery Moore, Manpower Counselor, Orleans
ment Act of 1974) authorizes the Secre-
ary 23, 1976. In response to that request,
County Council of Social Agencies
tary of the Department of Housing and
36 persons were nominated. Their quali-
(OCCSA). Newport, Vermont.
Urban Development to establish Federal
fications as well as those persons previ-
William R. Palmer, Editor, Mobile Homeown-
construction and safety standards for
ously nominated in 1975 and persons on
er's Association of N.J., Inc., Newspaper,
mobile homes. It provides for the ap-
the Council not serving until Decem-
Birmingham, New Jersey.
pointment by the Secretary of a National
ber 31, 1976, were evaluated and appoint-
Robert Myers, President, Michigan Mobile
Mobile Home Advisory Council composed
ments made from that group.
Home Owner's Association, Ypsilanti,
of 24 members. One-third of the mem-
In making its selections, the Depart-
Michigan.
bership of the Council is to be selected
ment, in general, sought to achieve geo-
Jane Conrad, American Mobile Home Associa-
from each of the following categories:
graphic balance in the Council and to
tion, Lakewood, Colorado.
(a) Consumer organizations, community
weigh that balance according to the size
organizations, and recognized consumer
of the mobile home industry and the
INDUSTRY REPRESENTATIVES
leaders; (b) the mobile home industry
number of mobile homes in use in each
Philip J. Braff, President, Braff Building Com-
and related groups including at least one
region of the country, and participation
pany, Madison, Ohio.
representative of small business; and (c)
by persons who would present it with a
William Stewart, California Mobilehome
government agencies including Federal,
broad spectrum of views.
Dealers Association, Sacramento, Call-
State and local governments. The Na-
Additionally, the Department decided
fornia.
tional Mobile Home Advisory Council
that: due to the wide interest in the
Charles T. Ashford, Vice President, Corp.
provides advice to the Secretary on the
Federal mobile home standards program
Purchasing and Engineering, Redman In-
development of initial Federal Mobile
and the need to get the broadest input
dustries, Dallas, Texas.
Home Construction and Safety Stand-
possible, no person would be permitted
ards and on changes in those standards.
Daniel Siegel, President and Chairman of the
to serve consecutive terms; that for the
Section 6(c) of the National Mobile
Board, Siegel Mobile Home Group, Siegel
same reasons persons associated with the
Home Advisory Council Charter stipu-
financial or insurance communities who
Financial Services, Salt Lake City, Utah.
lates that of the initially appointed
had no other interest in the program
The following members were previous-
members, one-half shall be appointed for
would not be appointed at this time. It
ly appointed and will continue to serve
one year, and one-half for two years. The
was also decided that, since the Federal
one and two year terms were evenly dis-
until December 31, 1976:
mobile home standards and enforcement
tributed among the three basic groups
programs contemplate participation to a
John L. Adams, President, Florida Coalition
which make up the Council, so that four
substantial extent by the states, and since
of Mobile Home Owners, Tampa, Florida.
members of each group have one year
inter-governmental participation may be
Peter B. Maier, Director, Mobile Home Task
terms and four members of each group
achieved by other means, representatives
Force, Center for Auto Safety, Washington,
have two year terms. The one year terms
of Federal agencies would not be ap-
D.C.
expired on April 30, 1976, and the initial
pointed to the Council.
Charles H. Mann, President, Federation of
two year terms expire on December 31,
Pursuant to the requirements of sec-
Mobile Home Owners, St. Petersburg, Flo-
1976. All future terms are for two years
tion 605 of Title VI of the Housing and
rida.
and expire on December 31 of the second
Community Development Act of 1974
Donald A. Barrow, Vice President, Skyline
year of the term.
(P.L. 93-383) and the Federal Advisory
Corporation, Elkhart, Indiana.
FEDERAL REGISTER, VOL. 41, NO. 135-TUESDAY, JULY 13, 1976