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The original documents are located in Box 20, folder "Medical Devices" of the Sarah C.
Massengale 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States of America his copyrights in all of his unpublished writings in National Archives collections.
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domain. The copyrights to materials written by other individuals or organizations are presumed to
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Digitized from Box 20 of The Sarah C. Massengale Files at the Gerald R. Ford Presidential Library
HEALTH.
of
DENICATION
Department of
Health, Education, and Welfare
!
Washington, D.C. 20201
USA
Ms. Needham
Date: July 28, 1975
The attached may be of interest to you.
Dale Sopper
Room 5448 North
Frank E. Samuel, Jr.
330 Independence Avenue, S.W.
Acting
Deputy Assistant Secretary
Telephone: (202) 245-7450
for Legislation (Health)
FOR RELEASE ONLY UPON DELIVERY
HEALTH
OF
DISUCATION
ARTMENT DEPARTMENT
DEPARTMENT OF HEALTH, EDUCATION. AND WELFARE
file
USA
medical
devices
H.R.5545
STATEMENT
BY
THEODORE COOPER, M.D.
ASSISTANT SECRETARY FOR HEALTH
BEFORE THE
SUBCOMMITTEE ON PUBLIC HEALTH AND ENVIRONMENT
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE
HOUSE OF REPRESENTATIVES
CERALD
MONDAY, JULY 28, 1975
Mr. Chairman and Members of the Subcommittee:
We are pleased to appear before you this morning to discuss
the need to assure the safety and effectiveness of medical
devices and to present our views on H.R. 5545, the Medical
Device Amendments of 1975.
The Federal Food, Drug, and Cosmetic Act, enacted in 1938 and
subsequently amended, has provided this Department with authority
to regulate drugs by requiring manufacturers to establish safety
and effectiveness prior to marketing. The Department has lacked
comparable authority for regulating medical devices.
As you are aware, the Department supported legislation similar
to H.R. 5545 in the 93rd Congress. If amended to meet a number
of objections outlined below, the Department would have no
objection to the substance of H.R. 5545. If this legislation
were to become law, the existing Bureau of Medical Devices and
Diagnostic Products within the Food and Drug Administration
would be charged with carrying out the responsibilities created
by the bill's enactment. The Committee should understand that
the Bureau would carry out a strengthened medical devices
regulation program within FDA's resources during the current
year.
- 2 -
INADEQUACIES OF CURRENT REGULATORY AUTHORITY
The regulatory authority of the Food and Drug Administration (FDA)
over medical devices has not been changed since 1938 despite enormous
progress in the scientific and technological disciplines related to
modern sophisticated products. Since current Federal law imposes no
duty upon medical device manufacturers to establish the safety and
effectiveness of their products prior to marketing, FDA has experienced
considerable difficulty in taking appropriate remedial action against
dangerous or misleading devices.
Although FDA does have some authority to regulate medical devices,
the Agency does not have clear authority to prescribe performance
standards to which devices must conform to assure that they are safe and
work properly. For example, there presently exist a number of device
standards relating to performance, structural engineering, and materials
composition which have been established by various medical and technical
organizations. These standards may, if properly applied, help assure
device safety and efficacy. FDA has encouraged development of voluntary
standards and has also attempted to make full use of its present authority
to develop certain requirements, such as those relating to portable
oxygen units.
Where a product is found to be defective, and the manufacturer does not
recall it, or make labeling corrections or repairs, FDA must resort to
legal proceedings which are cumbersome, time consuming, and not always
effective in removing products from the market.
- 3 -
Risks from medical devices can, however, also be addressed by a
preventive approach including, wherever applicable, the
establishment of general controls, such as current good manufacturing
practices, and performance standards applicable to product classes
in lieu of case-by-case actions. Where general controls and standards
are not sufficient to assure safety and effectiveness, the manufacturer,
not FDA, should bear the burden of proof concerning safety and
effectiveness through applications for product approval prior to
marketing.
HAZARDS OF MEDICAL DEVICES
Accurate statistics as to the number of deaths and injuries related
to medical devices are not available. We believe, however, that
the public is now being exposed to an undesirable level of risk.
1. In 1969, as Director of the National Heart and Lung Institute,
I headed a study group established by the Department on the safety
and efficacy of medical devices. As part of the study, we searched
the scientific literature for accounts of injuries associated with
medical devices. This studv uncovered 10,000 injuries of which 731
had resulted in death.
2. An FDA death certificate search of ten States covering ten years
(1962 to 1972) disclosed 858 deaths directly related to medical
devices.
- 4 -
3. The Commission on Professional and Hospital Activities, an
independent health group, projected an estimated 36,000
complications from medical devices in the year 1970.
4. The laboratory of the Downstate Medical Center, in Brooklyn,
which established its own review laboratory for medical devices for
use in that hospital, reported that fully 40 percent of the devices
tested were defective after two years of testing.
5. Recent problems, ranging from tragic deaths to fraudulent
marketing, have occurred with a number of different types of devices.
All of the following kinds of devices, which represent
different levels of potential harm to the consumer, should
be subject to careful regulation:
-- Devices which are used in life-threatening situations and which
are ineffective or fail in use--for example, heart valves,
cardiac pacemakers, vascular implants. We are aware that
about 23,000 individual pacemakers have been involved in
recalls since 1972. FDA is now involved in the
"recalls" of about 256 pacemakers and 54 myocardial
leads for use with pacemakers. Two children had died from
problems associated with the leads.
-- Devices that are hazardous to patients and/or medical
personnel due to defects in design or manufacture. For
example, there have been cases of faulty monitoring devices
in intensive-care units that have caused fatal electric
- 5 -
shock, and cases of defective anesthesia machines that
caused explosions in operating rooms. Also in this
category are EKG machines that give faulty readings
and result in serious misdiagnosis.
-- Devices in which the traditional risk-benefit assessment
cannot now be made prior to marketing--and in which the risks
outweigh the benefits--for example, certain IUD's. FDA
has learned of 43 deaths and 315 septic abortions
associated with IUD's. While these devices have been
shown to be a relatively safe and reliable form of
contraception, comparing favorably with oral contraceptives,
the injury data clearly indicates the need to evaluate
the potential hazards of all IUD's.
-- Devices that are useless and can cause delay in diagnosis,
and treatment of serious conditions, such as the old "quack"
colored lights devices.
-- Devices that are probably harmless but are useless and
therefore economic frauds, such as "hot pants" for weight
reduction.
STATUS OF PRESENT PROGRAM
As I mentioned, in 1969 this Department convened a study group to
devise the most appropriate means of assuring the safety and reliability
of medical devices. The Cooper Committee, as it became known, reported
its findings in 1970 and its recommendations were the basis for the
Department's bill to regulate medical devices and also for later versions
developed by Congress. The report called for the classification of
devices into three regulatory categories: (1) those devices subject
- 6 -
only to general regulatory controls; (2) those for which standards should
be set and enforced to assure safety and effectiveness; and (3) those
requiring premarket review.
The Committee also recommended ancillary provisions to fill existing gaps
in the law. These provisions included:
-- mandatory registration for establishments manufacturing
devices;
-- specific Federal authority to assure the use of good
manufacturing practices;
-- increased Federal inspection authority;
-- a requirement that device manufacturers maintain records
and make reports on clinical experience with devices; and
-- procedures to require manufacturers or distributors of
devices violative of Federal standards to repair or
replace the devices or refund their purchase price.
These features are all part of H.R. 5545.
In response to the Committee Report, the Secretary asked the FDA to develop
a system for the classification of medical devices into regulatory categories
consistent with the proposed legislative plan and to undertake an inventory
of these devices. This was to enable a smooth and orderly transition from
regulatory controls appropriate to the 1930's to those consistent with the
demands of the 1970's.
- 7 -
CLASSIFICATION OF DEVICES
Since the recommendations of the Cooper Committee, the FDA has completed
an inventory of devices. The classification process was begun with the
division of the inventory of devices into 14 separate categories generally
based on medical specialties in the following areas: orthopedics;
cardiovascular; dental; anesthesiology; obstetrical and gynecological;
gastroenterology and urology; radiology; neurology; ear, nose, and throat;
opthalmic; general and plastic surgery; physical medicine; diagnostic
products; and general hospital and personal use. Considerable progress
has been made in reviewing the devices in each of these 14 categories
and, through the use of panels of experts, classifying them into one or
more of the three regulatory control classes previously mentioned. It
should be noted that in addition to its expert members, each classification
panel has nonvoting representatives for both consumer interests and
industry interests. These procedures were formalized by notice in the
Federal Register of May 19, 1975 (40 FR 21848).
The first four panels to review and classify devices within their
respective medical specialty areas have already completed a large measure
of their work and are providing FDA with additonal scientific support and
direction. To date, over 3,000 devices have been classified by panels
into the three basic regulatory control categories identified by the
Cooper Committee.
- 8 -
OUTLINE OF PANELS' OPERATING PROCEDURES
It may be useful to describe the operations of the medical device review
panels. These panels have three basic functions:
1. Most importantly, to classify the devices into proposed
regulatory categories;
2. To identify the need for specific devices standards; and
3. To identify problems with specific devices.
Under the pending legislation, these panels would also assume the
important task of reviewing applications for premarket approval.
Once a panel has classified all the devices in its specialty area, it
considers specific device hazards and the requisite performance and
safety standards which some devices require. For specific complex
technical areas, the panels have sought advice from standard-setting
professional, medical, and scientific organizations such as the
Association for the Advancement of Medical Instrumentation (AAMI), in
the development of pacemaker performance and electromagnetic
compatibility standards and the American Society for Testing and
Materials (ASTM) in the development of standards for surgeons' gloves
and orthopedic implants. The International Organization for Standardization
(IOS) and the International Electrotechnical Commission (IEC) have also
been consulted.
- 9 -
VIEWS ON MEDICAL DEVICE LEGISLATION
As I have indicated, the Department has no objection to the
substance of H.R.5545, to provide a comprehensive new system
to help protect the public from unsafe or ineffective medical
devices. H.R. 5545 would provide for premarket approval of
certain devices, and promulgation of such standards as are
necessary to assure safe and effective performance.
The bill would also improve our authority concerning good manufacturing
practice regulations, records inspection, registration of device
manufacturers, maintenance of records and submission of reports, and
remedial action concerning hazardously defective devices.
The fundamental principles of H.R. 5545 are similar to S. 510,
a bill which was passed by the Senate earlier this year and
which the Department did not object to in substance. We
opposed the overly specific provision of S. 510 relating to
clinical investigational phase of medical device development
since that language would freeze into statutory form present
Department policy. This may prevent necessary administrative
updating to keep pace with biomedical technology, which may
soon need to be done after the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral
Research presents its findings. H.R. 5545, contains preferable
language which would give the FDA broad authority to issue
regulations to assure adequate protection of human subjects
of device testing without restricting the requirements to
what may today be considered necessary and appropriate.
- 10 -
We also opposed the premarket approval provisions of S. 510 as overly
broad and ambiguous. We proposed alternative language which tightened
up this category both by assigning to this category devices whose uses
are of substantial importance and by explaining that general controls
or standards are preferred to premarket approval. H.R. 5545
is similar to that proposed by the Department, but we still
prefer the Department's proposed provisions. We are attaching
a copy of our April 17 letter to Senator Scott in which this
provision was proposed. This language will assure that devices
that need premarket approval will get it, but without requiring
approval of trivial products which pose no risk to the consumer.
Another way in which H.R. 5545 is an improvement over S. 510 is in the
breadth of the recordkeeping and reporting authority provided in
section 519. This authority will enable us to require submission of
data relevant to classification, adulteration, or misbranding for all
devices. It is similar to the authority in the Department's proposed
Food Drug and Cosmetic Amendments of 1975 (H.R. 12847) in the last
Congress. We do, however, believe that the records and reports
provision in H.R. 5545 could be improved, as I will discuss in a few
minutes.
We are also pleased that H.R. 5545 includes authority to temporarily
detain devices suspected of violating the law. This was proposed in
the Department bill (H.R. 12847) in the last Congress.
- 11 -
We believe that the Subcommittee has developed a clear and
workable proposal which reflects the Cooper Committee report
and synthesizes the views of medical practitioners, research
scientists, engineers, consumer groups, industry, and Federal
agencies.
We are confident that the Agency's efforts thus far to classify
devices and establish standards have been wholly consistent with
the bill, and we hope the legislative history reflects this. We
believe it should be clearly understood that the FDA can build
upon what has been done already and can develop and use flexible
procedures consistent with Congressional intent.
Several features of H.R. 5545 cause us concern or could be improved
or clarified.
1. The procedure for establishing a standard includes two initial
steps that FDA believes can be collapsed into one. The bill should
combine the notice for submission of comments concerning the
establishment of a standard (proposed section 514(b)) with the
notice inviting submission of offers concerning the proposed
standards (proposed section 514(c)).
- 12 -
2. H.R. 5545 provides for an opportunity for review of a device
standard by an independent advisory committee which shall not be
a panel established for purposes of recommendations on classification
and premarket approval. We believe this provision can be changed
in a way that will allow FDA to make efficient use of its advisory
committees while assuring that standards are not reviewed by
individuals who may have prejudged an issue. We believe it is
enough that the bill prohibit inclusion on an independent advisory
committee of those individuals who have served on a classification
panel which had considered the particular standard under review.
3. The FDA has experienced great delays in removing unsafe and
ineffective drugs from the market. One problem with the current
drug law is the requirement of opportunity for a formal, evidentiary
hearing, as prescribed in 5 U.S.C. 554. H.R. 5545 would require the
FDA to provide opportunity for this same type of formal hearing when
the agency approves, denies, or withdraws approval of a device
application or takes comparable action regarding a product development
protocol. We believe that an informal hearing, as defined in the
bill, will assure fairness to interested persons without hindering
Agency activities.
- 13 -
4. We have related concerns about the banned device provisions of
section 516. Based on our experience with drug removals, we would
urge that all banning orders take effect upon publication and pending
any further administrative proceedings, including any decision as to
whether a hearing is to be held.
5. It is important that device manufacturers, importers, and distributors
notify the Agency of all defects in medical devices. This has been a
particular problem in our experience with pacemakers, where companies
have not told the Agency that they have found defects in their products
or that they have undertaken recalls. Under S. 510, there would
be specific defect notification authority as a part of the "3-R"
remedies--repair, replacement, or refund. However, this notifi-
cation authority would be limited to product-related defects
presenting a substantial risk to the public safety. Under
H.R. 5545, there would be no specific defect reporting provision,
but the general reporting provision of section 519 authorizes
regulations requiring defect reporting in all appropriate cases.
We favor the provisions of section 519 of H.R. 5545 which would
authorize us to require defect notification in instances in which
industry may not regard a degree of risk as "substantial," or
where it is unclear whether the risk is due to the product itself
or the lack of skill of users. However, we believe the Committee
should make it clear that the deletion of the specific defect
reporting provision is not meant to imply that FDA lacks authority
to require device manufacturers, importers, and distributors to
report device defects.
- 14 -
6. The records and reports provisions could be improved by deletion
of the provision in proposed section 519(a)(1) barring "requirements
unduly burdensome to a device manufacturer, importer, or distributor
taking into account his cost of complying with such requirements and
the need for the protection of the public health and the implementation
of this Act." This language is unnecessary in view of current and
proposed requirements that Federal agencies take into account the
economic impact of their requirements. These provisions would merely
lead to unproductive argument and possible litigation between FDA
and industry as to what is burdensome but would not add any real
safeguards to assure that burdensome requirements are not imposed.
Also, the section 519(a)(5) restrictions upon reporting authority
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 need.
It should be noted that if FDA does not have adequate authority to obtain
information on class I (general controls) devices, there will be an
incentive to place these devices in class II (standards) or class III
(premarket approval).
- 15 -
7. Researchers and teachers who directly import devices for their
own use should be subject to recordkeeping and reporting requirements,
which would require a change in proposed section 519(b)(2).
8. There is a need to allow marketing of custom devices which
necessarily deviate from requirements which would otherwise be
applicable to the device under the standard-setting or premarket
approval provisions of the bill. However, it is essential that
the custom device provisions not serve as a loophole that will
allow the marketing of dangerous or deceptive products. The custom
device provision of H.R. 5545 (section 520(b)) would not, as we
read the bill, exempt any device from otherwise applicable regulations
for investigational devices or banned 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 as a course of conduct on a number of 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 that
many of the devices used by certain practitioners, for example, dentists,
involve a certain degree of custom design for each patient, as a
course of conduct, and this is not objectionable. Thus, a provision
limiting use of custom devices as a course of conduct must be
carefully drafted to prevent abuses, but not to prevent use of
custom products where justified by medical need.
- 16 -
9. We understand the prescription device provisions of new section 520(e),
and related provisions in sections 514 and 515, would authorize restrictions
to assure effectiveness as well as safety. However, this understanding is
based upon our knowledge of similar terms used in drug law and may be
easily misunderstood by those who are not familiar with the history of
those terms. To prevent misunderstanding, these provisions should be
clarified, but it should be made clear that the Committee
does not intend to imply any limitations on our authority concerning
restrictions on use or distribution of drugs.
10. We believe it is unnecessary to require establishment of a separate
advisory committee to advise FDA concerning good manufacturing practice
regulations. Our 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. We also regard as unnecessary
an explicit system for petitions for exemption or variance from good
manufacturing practice regulations.
CONCLUSION
In summary, Mr. Chairman, we recognize the need for medical
device legislation. Within the budget restrictions and current
resource limitations which I alluded to earlier, this Department has no
objections to the substance of H.R. 5545, with the changes outlined above.
Mr. Chairman and Members of the Subcommittee, this concludes by
statement. My colleagues and I will be pleased to answer any
questions you may have.
of HEALTH EDUCATION
THE SECRETARY OF HEALTH, EDUCATION. AND WELFARE
DEPARTMENT
WASHINGTON, D.C. 20201
DEPARTMENT
17 APR 1975
Honorable Hugh Scott
Minority Leader
United States Senate
Washington, D. C. 20510
Dear Hugh:
There is before the Senate, as reported by the Committee on Labor and
Public Welfare, S. 510, the "Medical Device Amendments of 1975."
The reported bill is identical with S. 2368, which was passed by the
Senate during the 93rd Congress, providing the Food and Drug Adminis-
tration (FDA) with a number of new authorities relating to medical
devices. S. 510 would enable the establishment of mandatory standards,
require premarket scientific review in certain cases, and control
investigational devices. It would also require manufacturers to
register, maintain records, make reports, notify FDA of defective
products, and comply with good manufacturing practice regulations.
We have certain objections to the reported bill, as discussed below.
One of the principal issues of medical device legislation concerns
what types of devices should be subject to scientific review.
S. 510 provides that devices that are life-sustaining or life-supporting
must be classified as requiring premarket scientific review even if
standards or an exemption would be adequate. We believe this provision
is too broad and that the following alternative language would be
preferable to the first sentence of proposed section 514 (a) (1) of the
Act.
SEC. 514. (a) (1) The Secretary may declare that a device (or
type or class of device) for which scientific review has been
determined to be appropriate pursuant to section 511 (d) shall
be subject to scientific review under this section with respect
to any particular use or intended use thereof, if, after consul-
tation with the appropriate panel or panels specified in sub-
section (b), and finds that (A) insufficient information exists
(i) to assure effectiveness or (ii) to assure that exposure to
such devices will not cause unreasonable risk of illness or
injury and (B) scientific review may assure effectiveness or
may reduce or eliminate such unreasonable risk and (c) no more
practicable means to assure effectiveness or to reduce or eliminate
the unreasonable risk are appropriate and (D) the device purports
or is represented to be for a use which is of substantial
importance in supporting, sustaining, or preventing impairment
of human life or health. ***
Page Two - Honorable Hugh Scott
Conforming amendments would be needed in proposed section 511 of the Act
regarding criteria for classification of medical devices, including
deletion of the last sentence in proposed section 511 (c) (1) (B).
The Department also opposes the provision in the bill concerning pro-
tection of human subjects in device legislation. The excessive speci-
ficity of this language would freeze into law the current requirements
of Department policy, and thereby interfere with its further administra-
tive udpating to keep pace with developments in biomedical technology.
As you are aware, the Department supported legislation similar to
S. 510 in the 93rd Congress. If amended to meet the objections outlined
above, the Department would have no objections to the substance of S. 510.
If S. 510 were to become law, FDA's existing Bureau of Medical Devices
and Diagnostic Products would be charged with carrying out the responsi-
bilities created by the bill's enactment. The Senate should understand
that, because of budget restrictions, the Bureau would begin to implement
a strengthened medical devices regulation program within FDA's current
resources. No additional sums would be necessary in the current year.
In future years funds for this program will continue to be provided
by adjustments in existing programs rather than by any increase in the
FDA's budget.
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.
Sincerely,
Secretary
HEALTH.
FOR RELEASE ONLY UPON DELIVERY
0
DEPART BNY ARTMENT DEPARTMENT
DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE
file
U.S.A.
Coopa
statements
(medical
device
STATEMENT
BY
regul.)
THEODORE COOPER, M.D.
ASSISTANT SECRETARY FOR HEALTH
BEFORE THE
SUBCOMMITTEE ON PUBLIC HEALTH AND ENVIRONMENT
COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE
HOUSE OF REPRESENTATIVES
MONDAY, JULY 28, 1975
RAL GERALD ARRYBIT 1020
Mr. Chairman and Members of the Subcommittee:
We are pleased to appear before you this morning to discuss
the need to assure the safety and effectiveness of medical
devices and to present our views on H.R. 5545, the Medical
Device Amendments of 1975.
The Federal Food, Drug, and Cosmetic Act, enacted in 1938 and
subsequently amended, has provided this Department with authority
to regulate drugs by requiring manufacturers to establish safety
and effectiveness prior to marketing. The Department has lacked
comparable authority for regulating medical devices.
As you are aware, the Department supported legislation similar
to H.R. 5545 in the 93rd Congress. If amended to meet a number
of objections outlined below, the Department would have no
objection to the substance of H.R. 5545. If this legislation
were to become law, the existing Bureau of Medical Devices and
Diagnostic Products within the Food and Drug Administration
would be charged with carrying out the responsibilities created
by the bill's enactment. The Committee should understand that
the Bureau would carry out a strengthened medical devices
regulation program within FDA's resources during the current
year.
- 2 -
INADEQUACIES OF CURRENT REGULATORY AUTHORITY
The regulatory authority of the Food and Drug Administration (FDA)
over medical devices has not been changed since 1938 despite enormous
progress in the scientific and technological disciplines related to
modern sophisticated products. Since current Federal law imposes no
duty upon medical device manufacturers to establish the safety and
effectiveness of their products prior to marketing, FDA has experienced
considerable difficulty in taking appropriate remedial action against
dangerous or misleading devices.
Although FDA does have some authority to regulate medical devices,
the Agency does not have clear authority to prescribe performance
standards to which devices must conform to assure that they are safe and
work properly. For example, there presently exist a number of device
standards relating to performance, structural engineering, and materials
composition which have been established by various medical and technical
organizations. These standards may, if properly applied, help assure
device safety and efficacy. FDA has encouraged development of voluntary
standards and has also attempted to make full use of its present authority
to develop certain requirements, such as those relating to portable
oxygen units.
Where a product is found to be defective, and the manufacturer does not
recall it, or make labeling corrections or repairs, FDA must resort to
legal proceedings which are cumbersome, time consuming, and not always
effective in removing products from the market.
- 3 -
Risks from medical devices can, however, also be addressed by a
preventive approach including, wherever applicable, the
establishment of general controls, such as current good manufacturing
practices, and performance standards applicable to product classes
in lieu of case-by-case actions. Where general controls and standards
are not sufficient to assure safety and effectiveness, the manufacturer,
not FDA, should bear the burden of proof concerning safety and
effectiveness through applications for product approval prior to
marketing.
HAZARDS OF MEDICAL DEVICES
Accurate statistics as to the number of deaths and injuries related
to medical devices are not available. We believe, however, that
the public is now being exposed to an undesirable level of risk.
1. In 1969, as Director of the National Heart and Lung Institute,
I headed a study group established by the Department on the safety
and efficacy of medical devices. As part of the study, we searched
the scientific literature for accounts of injuries associated with
medical devices. This studv uncovered 10,000 injuries of which 731
had resulted in death.
2. An FDA death certificate search of ten States covering ten years
(1962 to 1972) disclosed 858 deaths directly related to medical
devices.
- 4 -
3. The Commission on Professional and Hospital Activities, an
independent health group, projected an estimated 36,000
complications from medical devices in the year 1970.
4. The laboratory of the Downstate Medical Center, in Brooklyn,
which established its own review laboratory for medical devices for
use in that hospital, reported that fully 40 percent of the devices
tested were defective after two years of testing.
5. Recent problems, ranging from tragic deaths to fraudulent
marketing, have occurred with a number of different types of devices.
All of the following kinds of devices, which represent
different levels of potential harm to the consumer, should
be subject to careful regulation:
-- Devices which are used in life-threatening situations and which
are ineffective or fail in use--for example, heart valves,
cardiac pacemakers, vascular implants. We are aware that
about 23,000 individual pacemakers have been involved in
recalls since 1972. FDA is now involved in the
"recalls" of about 256 pacemakers and 54 myocardial
leads for use with pacemakers. Two children had died from
problems associated with the leads.
-- Devices that are hazardous to patients and/or medical
personnel due to defects in design or manufacture. For
example, there have been cases of faulty monitoring devices
in intensive-care units that have caused fatal electric
- 5 -
shock, and cases of defective anesthesia machines that
caused explosions in operating rooms. Also in this
category are EKG machines that give faulty readings
and result in serious misdiagnosis.
-- Devices in which the traditional risk-benefit assessment
cannot now be made prior to marketing--and in which the risks
outweigh the benefits--for example, certain IUD's. FDA
has learned of 43 deaths and 315 septic abortions
associated with IUD's. While these devices have been
shown to be a relatively safe and reliable form of
contraception, comparing favorably with oral contraceptives,
the injury data clearly indicates the need to evaluate
the potential hazards of all IUD's.
-- Devices that are useless and can cause delay in diagnosis,
and treatment of serious conditions, such as the old "quack"
colored lights devices.
-- Devices that are probably harmless but are useless and
therefore economic frauds, such as "hot pants" for weight
reduction.
STATUS OF PRESENT PROGRAM
As I mentioned, in 1969 this Department convened a study group to
devise the most appropriate means of assuring the safety and reliability
of medical devices. The Cooper Committee, as it became known, reported
its findings in 1970 and its recommendations were the basis for the
Department's bill to regulate medical devices and also for later versions
developed by Congress. The report called for the classification of
devices into three regulatory categories: (1) those devices subject
- 6 -
only to general regulatory controls; (2) those for which standards should
be set and enforced to assure safety and effectiveness; and (3) those
requiring premarket review.
The Committee also recommended ancillary provisions to fill existing gaps
in the law. These provisions included:
-- mandatory registration for establishments manufacturing
devices;
-- specific Federal authority to assure the use of good
manufacturing practices;
-- increased Federal inspection authority;
-- a requirement that device manufacturers maintain records
and make reports on clinical experience with devices; and
-- procedures to require manufacturers or distributors of
devices violative of Federal standards to repair or
replace the devices or refund their purchase price.
These features are all part of H.R. 5545.
In response to the Committee Report, the Secretary asked the FDA to develop
a system for the classification of medical devices into regulatory categories
consistent with the proposed legislative plan and to undertake an inventory
of these devices. This was to enable a smooth and orderly transition from
regulatory controls appropriate to the 1930's to those consistent with the
demands of the 1970's.
- 7 -
CLASSIFICATION OF DEVICES
Since the recommendations of the Cooper Committee, the FDA has completed
an inventory of devices. The classification process was begun with the
division of the inventory of devices into 14 separate categories generally
based on medical specialties in the following areas: orthopedics;
cardiovascular; dental; anesthesiology; obstetrical and gynecological;
gastroenterology and urology; radiology; neurology; ear, nose, and throat;
opthalmic; general and plastic surgery; physical medicine; diagnostic
products; and general hospital and personal use. Considerable progress
has been made in reviewing the devices in each of these 14 categories
and, through the use of panels of experts, classifying them into one or
more of the three regulatory control classes previously mentioned. It
should be noted that in addition to its expert members, each classification
panel has nonvoting representatives for both consumer interests and
industry interests. These procedures were formalized by notice in the
Federal Register of May 19, 1975 (40 FR 21848).
The first four panels to review and classify devices within their
respective medical specialty areas have already completed a large measure
of their work and are providing FDA with additonal scientific support and
direction. To date, over 3,000 devices have been classified by panels
into the three basic regulatory control categories identified by the
Cooper Committee.
- 8 -
OUTLINE OF PANELS' OPERATING PROCEDURES
It may be useful to describe the operations of the medical device review
panels. These panels have three basic functions:
1. Most importantly, to classify the devices into proposed
regulatory categories;
2. To identify the need for specific devices standards; and
3. To identify problems with specific devices.
Under the pending legislation, these panels would also assume the
important task of reviewing applications for premarket approval.
Once a panel has classified all the devices in its specialty area, it
considers specific device hazards and the requisite performance and
safety standards which some devices require. For specific complex
technical areas, the panels have sought advice from standard-setting
professional, medical, and scientific organizations such as the
Association for the Advancement of Medical Instrumentation (AAMI), in
the development of pacemaker performance and electromagnetic
compatibility standards and the American Society for Testing and
Materials (ASTM) in the development of standards for surgeons' gloves
and orthopedic implants. The International Organization for Standardization
(IOS) and the International Electrotechnical Commission (IEC) have also
been consulted.
- 9 -
VIEWS ON MEDICAL DEVICE LEGISLATION
As I have indicated, the Department has no objection to the
substance of H.R.5545, to provide a comprehensive new system
to help protect the public from unsafe or ineffective medical
devices. H.R. 5545 would provide for premarket approval of
certain devices, and promulgation of such standards as are
necessary to assure safe and effective performance.
The bill would also improve our authority concerning good manufacturing
practice regulations, records inspection, registration of device
manufacturers, maintenance of records and submission of reports, and
remedial action concerning hazardously defective devices.
The fundamental principles of H.R. 5545 are similar to S. 510,
a bill which was passed by the Senate earlier this year and
which the Department did not object to in substance. We
opposed the overly specific provision of S. 510 relating to
clinical investigational phase of medical device development
since that language would freeze into statutory form present
Department policy. This may prevent necessary administrative
updating to keep pace with biomedical technology, which may
soon need to be done after the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral
Research presents its findings. H.R. 5545, contains preferable
language which would give the FDA broad authority to issue
regulations to assure adequate protection of human subjects
of device testing without restricting the requirements to
what may today be considered necessary and appropriate.
- 10 -
We also opposed the premarket approval provisions of S. 510 as overly
broad and ambiguous. We proposed alternative language which tightened
up this category both by assigning to this category devices whose uses
are of substantial importance and by explaining that general controls
or standards are preferred to premarket approval. H.R. 5545
is similar to that proposed by the Department, but we still
prefer the Department's proposed provisions. We are attaching
a copy of our April 17 letter to Senator Scott in which this
provision was proposed. This language will assure that devices
that need premarket approval will get it, but without requiring
approval of trivial products which pose no risk to the consumer.
Another way in which H.R. 5545 is an improvement over S. 510 is in the
breadth of the recordkeeping and reporting authority provided in
section 519. This authority will enable us to require submission of
data relevant to classification, adulteration, or misbranding for all
devices. It is similar to the authority in the Department's proposed
Food Drug and Cosmetic Amendments of 1975 (H.R. 12847) in the last
Congress. We do, however, believe that the records and reports
provision in H.R. 5545 could be improved, as I will discuss in a few
minutes.
We are also pleased that H.R. 5545 includes authority to temporarily
detain devices suspected of violating the law. This was proposed in
the Department bill (H.R. 12847) in the last Congress.
- 11 -
We believe that the Subcommittee has developed a clear and
workable proposal which reflects the Cooper Committee report
and synthesizes the views of medical practitioners, research
scientists, engineers, consumer groups, industry, and Federal
agencies.
We are confident that the Agency's efforts thus far to classify
devices and establish standards have been wholly consistent with
the bill, and we hope the legislative history reflects this. We
believe it should be clearly understood that the FDA can build
upon what has been done already and can develop and use flexible
procedures consistent with Congressional intent.
Several features of H.R. 5545 cause us concern or could be improved
or clarified.
1. The procedure for establishing a standard includes two initial
steps that FDA believes can be collapsed into one. The bill should
combine the notice for submission of comments concerning the
establishment of a standard (proposed section 514(b)) with the
notice inviting submission of offers concerning the proposed
standards (proposed section 514(c)).
- 12 -
2. H.R. 5545 provides for an opportunity for review of a device
standard by an independent advisory committee which shall not be
a panel established for purposes of recommendations on classification
and premarket approval. We believe this provision can be changed
in a way that will allow FDA to make efficient use of its advisory
committees while assuring that standards are not reviewed by
individuals who may have prejudged an issue. We believe it is
enough that the bill prohibit inclusion on an independent advisory
committee of those individuals who have served on a classification
panel which had considered the particular standard under review.
3. The FDA has experienced great delays in removing unsafe and
ineffective drugs from the market. One problem with the current
drug law is the requirement of opportunity for a formal, evidentiary
hearing, as prescribed in 5 U.S.C. 554. H.R. 5545 would require the
FDA to provide opportunity for this same type of formal hearing when
the agency approves, denies, or withdraws approval of a device
application or takes comparable action regarding a product development
protocol. We believe that an informal hearing, as defined in the
bill, will assure fairness to interested persons without hindering
Agency activities.
- 13 -
4. We have related concerns about the banned device provisions of
section 516. Based on our experience with drug removals, we would
urge that all banning orders take effect upon publication and pending
any further administrative proceedings, including any decision as to
whether a hearing is to be held.
5. It is important that device manufacturers, importers, and distributors
notify the Agency of all defects in medical devices. This has been a
particular problem in our experience with pacemakers, where companies
have not told the Agency that they have found defects in their products
or that they have undertaken recalls. Under S. 510, there would
be specific defect notification authority as a part of the "3-R"
remedies--repair, replacement, or refund. However, this notifi-
cation authority would be limited to product-related defects
presenting a substantial risk to the public safety. Under
H.R. 5545, there would be no specific defect reporting provision,
but the general reporting provision of section 519 authorizes
regulations requiring defect reporting in all appropriate cases.
We favor the provisions of section 519 of H.R. 5545 which would
authorize us to require defect notification in instances in which
industry may not regard a degree of risk as "substantial," or
where it is unclear whether the risk is due to the product itself
or the lack of skill of users. However, we believe the Committee
should make it clear that the deletion of the specific defect
reporting provision is not meant to imply that FDA lacks authority
to require device manufacturers, importers, and distributors to
report device defects.
- 14 -
6. The records and reports provisions could be improved by deletion
of the provision in proposed section 519(a) (1) barring "requirements
unduly burdensome to a device manufacturer, importer, or distributor
taking into account his cost of complying with such requirements and
the need for the protection of the public health and the implementation
of this Act." This language is unnecessary in view of current and
proposed requirements that Federal agencies take into account the
economic impact of their requirements. These provisions would merely
lead to unproductive argument and possible litigation between FDA
and industry as to what is burdensome but would not add any real
safeguards to assure that burdensome requirements are not imposed.
Also, the section 519(a)(5) restrictions upon reporting authority
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 need.
It should be noted that if FDA does not have adequate authority to obtain
information on class I (general controls) devices, there will be an
incentive to place these devices in class II (standards) or class III
(premarket approval).
- 15 -
7. Researchers and teachers who directly import devices for their
own use should be subject to recordkeeping and reporting requirements,
which would require a change in proposed section 519(b)(2).
8. There is a need to allow marketing of custom devices which
necessarily deviate from requirements which would otherwise be
applicable to the device under the standard-setting or premarket
approval provisions of the bill. However, it is essential that
the custom device provisions not serve as a loophole that will
allow the marketing of dangerous or deceptive products. The custom
device provision of H.R. 5545 (section 520(b)) would not, as we
read the bill, exempt any device from otherwise applicable regulations
for investigational devices or banned 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 as a course of conduct on a number of 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 that
many of the devices used by certain practitioners, for example, dentists,
involve a certain degree of custom design for each patient, as a
course of conduct, and this is not objectionable. Thus, a provision
limiting use of custom devices as a course of conduct must be
carefully drafted to prevent abuses, but not to prevent use of
custom products where justified by medical need.
- 16 -
9. We understand the prescription device provisions of new section 520(e),
and related provisions in sections 514 and 515, would authorize restrictions
to assure effectiveness as well as safety. However, this understanding is
based upon our knowledge of similar terms used in drug law and may be
easily misunderstood by those who are not familiar with the history of
those terms. To prevent misunderstanding, these provisions should be
clarified, but it should be made clear that the Committee
does not intend to imply any limitations on our authority concerning
restrictions on use or distribution of drugs.
10. We believe it is unnecessary to require establishment of a separate
advisorv committee to advise FDA concerning good manufacturing practice
regulations. Our 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. We also regard as unnecessary
an explicit system for petitions for exemption or variance from good
manufacturing practice regulations.
CONCLUSION
In summary, Mr. Chairman, we recognize the need for medical
device legislation. Within the budget restrictions and current
resource limitations which I alluded to earlier, this Department has no
objections to the substance of H.R. 5545, with the changes outlined above.
Mr. Chairman and Members of the Subcommittee, this concludes by
statement. My colleagues and I will be pleased to answer any
questions you may have.
HEALTH EDUCATION
THE SECRETARY OF HEALTH. EDUCATION, AND WELFARE
DEPARTMENT
WASHINGTON. D.C. 20201
DEPARTMENT
17 APR 1075
Honorable Hugh Scott
Minority Leader
United States Senate
Washington, D. C. 20510
Dear Hugh:
There is before the Senate, as reported by the Committee on Labor and
Public Welfare, S. 510, the "Medical Device Amendments of 1975."
The reported bill is identical with S. 2368, which was passed by the
Senate during the 93rd Congress, providing the Food and Drug Adminis-
tration (FDA) with a number of new authorities relating to medical
devices. S. 510 would enable the establishment of mandatory standards,
require premarket scientific review in certain cases, and control
investigational devices. It would also require manufacturers to
register, maintain records, make reports, notify FDA of defective
products, and comply with good manufacturing practice regulations.
We have certain objections to the reported bill, as discussed below.
One of the principal issues of medical device legislation concerns
what types of devices should be subject to scientific review.
S. 510 provides that devices that are life-sustaining or life-supporting
must be classified as requiring premarket scientific review even if
standards or an exemption would be adequate. We believe this provision
is too broad and that the following alternative language would be
preferable to the first sentence of proposed section 514 (a) (1) of the
Act.
SEC. 514. (a) (1) The Secretary may declare that a device (or
type or class of device) for which scientific review has been
determined to be appropriate pursuant to section 511 (d) shall
be subject to scientific review under this section with respect
to any particular use or intended use thereof, if, after consul-
tation with the appropriate panel or panels specified in sub-
section (b), and finds that (A) insufficient information exists
(i) to assure effectiveness or (ii) to assure that exposure to
such devices will not cause unreasonable risk of illness or
injury and (B) scientific review may assure effectiveness or
may reduce or eliminate such unreasonable risk and (C) no more
practicable means to assure effectiveness or to reduce or eliminate
the unreasonable risk are appropriate and (D) the device purports
or is represented to be for a use which is of substantial
importance in supporting, sustaining, or preventing impairment
of human life or health. ***
Page Two - Honorable Hugh Scott
Conforming amendments would be needed in proposed section 511 of the Act
regarding criteria for classification of medical devices, including
deletion of the last sentence in proposed section 511 (c) (1) (B).
The Department also opposes the provision in the bill concerning pro-
tection of human subjects in device legislation. The excessive speci-
ficity of this language would freeze into law the current requirements
of Department policy, and thereby interfere with its further administra-
tive udpating to keep pace with developments in biomedical technology.
As you are aware, the Department supported legislation similar to
S. 510 in the 93rd Congress. If amended to meet the objections outlined
above, the Department would have no objections to the substance of S. 510.
If S. 510 were to become law, FDA's existing Bureau of Medical Devices
and Diagnostic Products would be charged with carrying out the responsi-
bilities created by the bill's enactment. The Senate should understand
that, because of budget restrictions, the Bureau would begin to implement
a strengthened medical devices regulation program within FDA's current
resources. No additional sums would be necessary in the current year.
In future years funds for this program will continue to be provided
by adjustments in existing programs rather than by any increase in the
FDA's budget.
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.
Sincerely,
Secretary
fee
THE WHITE HOUSE
WASHINGTON
April 4, 1975
MEMO TO :
Way
FROM :
SUBJECT : *Medical Device
Legislation
The attached is forwarded
for
X Your handling
FYI
Other
Attachment *Memo from Secretary
Weinberger
THE WHITE HOUSE
WASHINGTON
4.4.75
TO: Waven Hendriks
For Your Information
For Appropriate Handling
por
Robert D. Linder
EDUCA
THE SECRETARY OF HEALTH. EDUCATION, AND WELFARE
DEPARTMENT
WASHINGTON, D. C. 20201
MASSACHUSETTS
MEMORANDUM FOR THE PRESIDENT
April 3, 1975
FROM
:
CASPAR W. WEINBERGER
SUBJECT: Medical Device Legislation
OMB has advised us of your decision not to re-propose to the Congress
legislation which the Administration previously sponsored if such
legislation would cost additional resources not specifically included
in your 1976 budget, even though it may be mentioned in the budget.
One legislative proposal which is in this category and which I wish
to bring to your attention involves authority to regulate medical
devices. The circumstances surrounding this piece of legislation
are such that you may wish us to support it even though it may be
viewed by some as an exception to your general rule. Actually, I
do not believe it requires an exception to that rule; it can and
should be a no-cost proposal this year, and therefore need not be
"caught in the net" of that rule.
The legislation would provide the Food and Drug Administration with
needed authority to establish mandatory standards for medical devices,
require premarket scientific review in certain cases, and control
investigational devices. We have sought sensible legislation in this
field in order to preclude such problems as defective pacemakers,
implanted heart valves, kidney dialysis machines, and potentially
dangerous intrauterine devices. Because of the critical nature of
these devices even a very small error rate results in significant
human tragedy, and SO this new legislation is clearly in the
"humanitarian" category.
The problem in not supporting medical device legislation this year is
greater than just the fact that the Administration has supported this
legislation in the past two Congresses. Prior to your decision the
Food and Drug Commissioner, in testimony this year before the Congress,
has used our medical device legislation and its prospective trans-
mission to the Congress as a basis for heading off other undesirable
legislation. He offered such testimony in good faith, believing that
legislation would soon be transmitted based on our past support. It
is reasonably clear that the Congress will pass some legislation on
medical devices this session no matter what we say. But failure of
the Administration to take a positive position on this legislation
would place the Department in an awkward position at best.
2
Because I both understand and agree with your strong position to
hold down Federal expenditures, I think we cannot proceed with
this proposal in a "business as usual" fashion. We could, however,
take the position that we favor enactment of this legislation this
year with the understanding that implementation in FY 1976 would
be conducted within resources already budgeted for the Food and
Drug Administration. Given the circumstances in this case, I would
prefer to proceed in this fashion if you agree.
I have attached at Tab A a copy of my draft letter to Senator Scott
on the pending medical devices bill. The letter favors enactment
this year but indicates an intention to implement within available
resources in 1976. The letter to Senator Scott does state, correctly,
that additional resources will be required in Fiscal 1977.
Recommendation
I recommend that you endorse our support of a medical devices bill
but at no additional FY 1976 cost.
Decision
Support medical devices bill but
at no additional FY 1976 cost
Do not support medical devices bill
Attachment
Tab A
Honorable Hugh Scott
Minority Leader
Uinited States Senate
Washington, D. C. 20510
Dear Hugh:
There is before the Senate, as reported by the Committee on Labor and
Public Welfare, S. 510, the "Medical Device Amendments of 1975."
The reported bill is identical with S. 2368, which was passed by the
Senate during the 93rd Congress, providing the Food and Drug Adminis-
tration (FDA) with a number of new authorities relating to medical
devices. S. 510 would enable the establishment of mandatory standards,
require premarket scientific review in certain cases, and control
investigational devices. It would also require manufacturers to
register, maintain records, make reports, notify FDA of defective
products, and comply with good manufacturing practice regulations.
We have certain objections to the reported bill, as discussed below.
One of the principal issues of medical device legislation concerns
what types of devices should be subject to scientific review.
Page 2 - Honorable Hugh Scott
S. 510 provides that devices that are life-sustaining or life-supporting
must be classified as requiring premarket scientific review even if
standards or an exemption would be adequate. We believe this provision
is too broad and that the following alternative language would be
preferable to the first sentence of proposed section 514 (a) (1) of the
Act.
SEC. 514. (a) (1) The Secretary may declare that a device (or
type or class of device) for which scientific review has been
determined to be appropriate pursuant to section 511 (d) shall
be subject to scientific review under this section with respect
to any particular use or intended use thereof, if, after consul-
tation with the appropriate panel or. panels specified in sub-
section (b), he finds that (A) insufficient information exists
(i) to assure effectiveness or (ii) to assure that exposure to
such devices will not cause unreasonable risk of illness or
injury and (B) scientific review may assure effectiveness or
may reduce or eliminate such unreasonable risk and (C) no more
practicable means to assure effectiveness or to reduce or eliminate
the unreasonable risk are appropriate and (D) the device purports
or is represented to be for a use which is of substantial
importance in supporting, sustaining, or preventing impairment
of human life or health. ***
Conforming amendments would be needed in proposed section 511 of the Act
regarding criteria for classification of medical devices, including
Page 3 - Honorable Hugh Scott
deletion of the last sentence in proposed section 511 (c) (1) (B).
The Department also opposes the provision in the bill concerning pro-
tection of human subjects in device investigations. The excessive
specificity of this language would freeze into law the current
requirements of Department policy, and thereby interfere with its
further administrative updating to keep pace with developments in
biomedical technology.
As you are aware, the Department supported legislation similar to
S. 510 in the 93rd Congress. If amended to meet the objections
outlined above, the Department also supports enactment of S. 510.
FDA's existing Bureau of Medical Devices and Diagnostic Products would
be charged with carrying out the responsibilities created by the
bill's enactment. Because of the President's decision not to initiate
new spending programs this year, the Bureau would begin to implement
a strengthened medical devices regulation program within FDA's
current resources. Additional resources necessary to implement
enacted legislation would be requested in the President's Budget
for FY 1977.
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.
Sincerely,
Secretary
red. 4/16/75
Honorable Hugh Scott
Minority Leader
Uinited States Senate
Washington, D. C. 20510
Dear llugh:
There is before the Senate, as reported by the Committee on Labor and
Public Welfare, S. 510, the "Medical Device Amendments of 1975. "
The reported bill is identical with S. 2368, which was passed by the
Senate during the 93rd Congress, providing the Food and Drug Adminis-
tration (FDA) with a number of new authorities relating to medical
devices. S. 510 would enable the establishment of mandatory standards,
require premarket scientific review in certain cases, and control
investigational devices. It would also require manufacturers to
register, maintain records, make reports, notify FDA of defective
products, and comply with good manufacturing practice regulations.
We have certain objections to the reported bill, as discussed below.
One of the principal issues of medical device legislation concerns
what types of devices should be subject to scientific review.
recial daily Misch A.M.
Page 2 - Honorable llugh Scott
S. 510 provides that devices that are life-sustaining or life-supporting
must be classified as requiring premarket scientific review even if
standards or an exemption would be adequate. We believe this provision
is too broad and that the following alternative language would be
preferable to the first sentence of proposed section 514 (a) (1) of the
Act.
SEC. 514. (a) (1) The Secretary may declare that a device (or
type or class of device) for which scientific review has been
determined to be appropriate pursuant to section 511 (d) shall
be subject to scientific review under this section with respect
to any particular use or intended use thereof, if, after consul-
tation with the appropriate panel or. panels specified in sub-
section (b), he finds that (A) insufficient information exists
(i) to assure effectiveness or (ii) to assure that exposure to
such devices will not cause unreasonable risk of illness or
injury and (B) scientific review may assure effectiveness or
may reduce or eliminate such unreasonable risk and (c) no more
practicable means to assure effectiveness or to reduce or eliminate
the unreasonable risk are appropriate and (D) the device purports
or is represented to be for a use which is of substantial
importance in supporting, sustaining, or preventing impairment
of human life or health. ***
Conforming amendments would be needed in proposed section 511 of the A
regarding criteria for classification of medical devices, including
Page 3 Nonorable Hugh Scott
deletion of the last sentence in proposed section 511 (c) (1) (B).
The Department also opposes the provision in the bill concerning pro-
tection of human subjects in device investigations. The excessive
specificity of this language would freeze into law the current
requirements of Department policy, and thereby interfere with its
further administrative updating to keep pace with developments in
biomedical technology.
inx
A
As you are aware, the Department supported legislation similar to
S. 510 in the 93rd Congress. If amended to meet the objections,
would
have
no
did
to
MC
É
outlined above, the Department also supports enactment of S. 510,
Amount Amusicall atter tion to te Presidents
existing Bureau of Medical Devices and Diagnostic Products would
policy be charged urgin with that carrying no new out the money responsibilities the grasted created by the this
year bill's robickus enactment. Because of the increased President's decision Inc. not to SRe initiate
over new the spending ann programs Ts this refer year, cries the Bureau would - his begin budget. to implement Specifically
the Presion 1 pai 1/m his State the Un admiss
1/
a strengthened medical devices regulation program within FDA
B no new spending programs can va
current resources Additional resources necessary to implement
initiated this gean, except bas Energy."
enacted legislation would be requested in the President's Budget
I have [abso] concluded that
for FY 1977.
A
those
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.
Sincerely,
Secretary
Don Hirsch
HEW
Rm. 5109
245-7760
INSERT
A
As you are aware, the Department supported legislation
similar to S. 510 in the 93rd Congress. If amended to
meet the objections outlined above, the Department would
have no objection to the substance of S. 510. However,
I must call your attention to the President's policy
urging that no new programs be enacted this year which
would require increased Federal spending over the amounts
recommended in his budget. Specifically, the President
said in his State of the Union address:
"I have [also] concluded that no new spending
programs can be initiated this year, except
those for energy. "
INCALITY
EDUC
THE SECRETARY OF HEALTH. EDUCATION, AND WELFARE
AND
DEPARTMENT
WASHINGTON, D. C. 20201
MEMORANDUM FOR THE PRESIDENT
April 3, 1975
FROM
:
CASPAR W. WEINBERGER
SUBJECT: Medical Device Legislation
OMB has advised us of your decision not to re-propose to the Congress
legislation which the Administration previously sponsored if such
legislation would cost additional resources not specifically included
in your 1976 budget, even though it may be mentioned in the budget.
One legislative proposal which is in this category and which I wish
to bring to your attention involves authority to regulate medical
devices. The circumstances surrounding this piece of legislation
are such that you may wish us to support it even though it may be
viewed by some as an exception to your general rule. Actually, I
do not believe it requires an exception to that rule; it can and
should be a no-cost proposal this year, and therefore need not be
"caught in the net" of that rule.
The legislation would provide the Food and Drug Administration with
needed authority to establish mandatory standards for medical devices,
require premarket scientific review in certain cases, and control
investigational devices. We have sought sensible legislation in this
field in order to preclude such problems as defective pacemakers,
implanted heart valves, kidney dialysis machines, and potentially
dangerous intrauterine devices. Because of the critical nature of
these devices even a very small error rate results in significant
human tragedy, and SO this new legislation is clearly in the
"humanitarian" category.
The problem in not supporting medical device legislation this year is
greater than just the fact that the Administration has supported this
legislation in the past two Congresses. Prior to your decision the
Food and Drug Commissioner, in testimony this year before the Congress,
has used our medical device legislation and its prospective trans-
mission to the Congress as a basis for heading off other undesirable
legislation. He offered such testimony in good faith, believing that
legislation would soon be transmitted based on our past support. It
is reasonably clear that the Congress will pass some legislation on
medical devices this session no matter what we say. But failure of
the Administration to take a positive position on this legislation
would place the Department in an awkward position at best.
2
Because I both understand and agree with your strong position to
hold down Federal expenditures, I think we cannot proceed with
this proposal in a "business as usual" fashion. We could, however,
take the position that we favor enactment of this legislation this
year with the understanding that implementation in FY 1976 would
be conducted within resources already budgeted for the Food and
Drug Administration. Given the circumstances in this case, I would
prefer to proceed in this fashion if you agree.
I have attached at Tab A a copy of my draft letter to Senator Scott
on the pending medical devices bill. The letter favors enactment
this year but indicates an intention to implement within available
resources in 1976. The letter to Senator Scott does state, correctly,
that additional resources will be required in Fiscal 1977.
Recommendation
I recommend that you endorse our support of a medical devices bill
but at no additional FY 1976 cost.
Decision
Support medical devices bill but
at no additional FY 1976 cost
Do not support medical devices bill
Attachment
TabA
Honorable Hugh Scott
Minority Leader
Uinited States Senate
Washington, D. C. 20510
Dear Hugh:
There is before the Senate, as reported by the Committee on Labor and
Public Welfare, S. 510, the "Medical Device Amendments of 1975."
The reported bill is identical with S. 2368, which was passed by the
Senate during the 93rd Congress, providing the Food and Drug Adminis-
tration (FDA) with a number of new authorities relating to medical
devices. S. 510 would enable the establishment of mandatory standards,
require premarket scientific review in certain cases, and control
investigational devices. It would also require manufacturers to
register, maintain records, make reports, notify FDA of defective
products, and comply with good manufacturing practice regulations.
We have certain objections to the reported bill, as discussed below.
One of the principal issues of medical device legislation concerns
what types of devices should be subject to scientific review.
Page 2 - Honorable Hugh Scott
S. 510 provides that devices that are life-sustaining or life-supporting
must be classified as requiring premarket scientific review even if
standards or an exemption would be adequate. We believe this provision
is too broad and that the following alternative language would be
preferable to the first sentence of proposed section 514 (a) (1) of the
Act.
SEC. 514. (a) (1) The Secretary may declare that a device (or
type or class of device) for which scientific review has been
determined to be appropriate pursuant to section 511 (d) shall
be subject to scientific review under this section with- respect
to any particular use or intended use thereof, if, after consul-
tation with the appropriate panel or. panels specified in sub-
section (b), he finds that (A) insufficient information exists
(i) to assure effectiveness or (ii) to assure that exposure to
such devices will not cause unreasonable risk of illness or
injury and (B) scientific review may assure effectiveness or
may reduce or eliminate such unreasonable risk and (c) no more
practicable means to assure effectiveness or to reduce or eliminate
the unreasonable risk are appropriate and (D) the device purports
or is represented to be for a use which is of substantial
importance in supporting, sustaining, or preventing impairment
of human life or health. ***
Conforming amendments would be needed in proposed section 511 of the Act
regarding criteria for classification of medical devices, including
Page 3 - Honorable Hugh Scott
deletion of the last sentence in proposed section 511 (c) (1) (B).
The Department also opposes the provision in the bill concerning pro-
tection of human subjects in device investigations. The excessive
specificity of this language would freeze into law the current
requirements of Department policy, and thereby interfere with its
further administrative updating to keep pace with developments in
biomedical technology.
As you are aware, the Department supported legislation similar to
S. 510 in the 93rd Congress. If amended to meet the objections
outlined above, the Department also supports enactment of S. 510.
FDA's existing Bureau of Medical Devices and Diagnostic Products would
be charged with carrying out the responsibilities created by the
bill's enactment. Because of the President's decision not to initiate
new spending programs this year, the Bureau would begin to implement
a strengthened medical devices regulation program within FDA's
current resources. Additional resources necessary to implement
enacted legislation would be requested in the President's Budget
for FY 1977.
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.
Sincerely,
Secretary
HEALTH.
DEPARTMENT
OF
THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE
AND WELFARE
WASHINGTON, D. C. 20201
APR 10 1975
MEMORANDUM
FOR
THE
PRESIDENT
SUBJECT: FROM : Medical Caspar W. Device Weinberger Legislation
RL
You may have noted in the newspapers of April 8, 1975 (attachment),
the articles referring to those heart pacemaker deficiencies
which resulted in the death of 8 patients. It is possible
that another 18 deaths will be attributed to deficiencies in
these devices.
Heart pacemakers are devices which electrically stimulate the
heart and cause it to beat at prescribed rates and regularity.
Certain forms of heart disease result in failure of the normal
mechanism which causes the heart to beat. The implantation of
a pacemaker may make the difference between life and death.
When properly functioning, the pacemaker application can result
in restoration of the patient to a productive life.
In order to prevent the implantation of faulty pacemakers, we
need the authority to review the devices before they are sold
to physicians. It is this type of problem which has been the
basis of my interest in the new medical device legislation. I
have called your attention to the legislation in my memorandum
to you dated April 3, 1975 (attachment). It occurred to me
that this specific example may help clarify my reason for asking
you to endorse our support of a medical devices bill at no
additional FY 1976 cost.
U.S. Department of Health, Education, and Welfare.
Office of Public Affairs
News Items
Vol. 21 - No. 69
April 8, 1975
Balt. Sun
Wall Street Jour,
April 8, 1975, P. 7
April 8, 1975, P. 16
26 deaths associated with
Defective Pacemakers
Involved in 26 Deaths,
defective pacemakers, U.S. says
HEW Secretary Says
Cordis recall of 11,050
manufacturing-practice regula
Washington
Ph-Defective
deaths associated with acceler-
WASHINGTON (AP)-Defective cardiac
cardiac pacemakers have been
ated pulse rate and three oth-
asynchronous pacemakers in
tions this year to govern the pacemakers have been associated with at
associated with at least 26
ers of questionable cause.
July 1973, one death associated
quality of materials. parts and least 26 deaths of heart patients in the past
deaths of heart patients over
GE recall of 1.241 units
with high pacing. The FDA
processing of pacemakers, to three years. the Secretary of Health, Educa-
the last three years, the secre-
between June 1974 and Febru-
said it is still investigating 12
reduce defects. In addition, he
tion and Welfare sald.
tary of Health, Education and
ary 1975. two deaths associated
deaths "associated with high-
said the National Bureau of
Eight of the deaths were directly attrib-
with accelerated pacing.
pacing-rate pacemakers as de-
Standards has developed new
uted to implanted pacemaker failures. See-
Welfare said yesterday.
Eight of the deaths were
Biotronik recail of 255
termined from an examination
test and evaluation methods.
retary Caspar Weinberger said. and 18 other
attributed to the failure of im-
pacemakers in February and
deaths are under investigation.
of records obtained from the
Responding to Senator Ribi-
planted pacemakers. Secretary
October 1974. one death and 27
firm."
Mr. Weinberger's 11-page letter
coff's suggestion that the Navy
was
injuries associated with inflam-
hand delivered to Sen. Abraham Ribicoff
Caspar W. Weinberger said,
Vitatron recall of 506
standard should have been
and 16 other deaths gleaned
mation and dead tissue alleg-
(D., Conn.): chairman of the Senate Govern-
pacemakers in June and Octo-
adopted, the secretary said
ment Operations Committee, who asked for
from company files are under
edly caused by leaking batter-
ber 1974 and March 1975. four
manufacturers have been her-
administration comment on a recent Gen-
investigation.
ies.
injuries involving high pacing
metically sealing semi-conduc-
eral Accounting Office report.
Secretary Weinberger's 11-
Cordis recall of 4.900 de-
and loss of output.
tor devices since the early
Congressional auditors were critical of
page letter was hand-delivered
mand-type pacemakers in Oc-
Secretary Weinberger said
1960's. The entire unit cannot the Food and Drug Administration's han-
to Senator Abrabam Ribicolf
tober 1973 and February 1975.
the FDA will propose good
be sealed. however, because diing of the recall of about 23,000 pacemak-
ID., Conn.), chairman of the
still under investigation with
mercury batteries produce hy- ers by General Electric Co., Cordis Corp.,
Senate Government Operations
no report on deaths or injuries.
drogen
gas
which
must
be
re-
Miami, Fla.: Biotronik Corp., West Ger-
Committee. who had asked for
leased, he said.
many. and Vitatronics Medical Inc., the
administration comment on a
Netherlands.
recent General Accounting Oi-
Until now, the FDA. which regulates
fice report.
medical devices. including pacemakers, has
Congressiona! auditors were
placed the toll at fewer than 10 deaths. An.
critical of the Food and Drug
estimated 125.000 Americans have surgi-
Administration's handling of
cally implanted pacemakers to regulate
the recall of about 23.000 pace-
their heart beat.
makers by General Electric,
Mr. Weinberger said all the device fail-
Biotronik, Cordis and Vitatron
ures were due to "improper" design. mate-
since 1972.
rial or part selection, or processing" rather.
Until now, the FDA, which
than, as Sen. Ribico!! has charged. to the
agency's rejection of a 1969 Navy standard.
regulates medical devices, in-
for hermetically sealing electronic parts.
cluding pacemakers, has
placed the toll at fewer than 10
"FDA at this time doesn't believe impo-
deaths. An estimated 125.000
sition of & standard simply to require the
Americans have surgically-im-
hermetic sealing of all implanted pacemak-
ers is necessary or wise," Mr. Weinberger's
planted pacemakers to regu-
letter said. "Moreover. it could introduce
late their heart beat.
Secretary Weinberger said
other problems which would adversely 25-
fect the present utility of pacemakers."
all the device failures were
Mr. Weinberger said It often is difficult
due to "improper design. ma-
terial or component selection,
to determine whether a pacemaker failure
or processing" and not, as Sen-
resulted in death or injury. He said pace-
maker patients range from infants with con-
ator Ribicoff charged, to the
agency's rejection of a 1969
genital defects to elderly persons suffering
from arterioscierosis, "all whose hearts are
Navy standard for heremeti-
defective and whose deaths often aren't un-
cally sealing electronic compo-
expected."
nents.
Mr. Weinberger said the FDA will pro-
"FDA at this time does not
believe imposition of a stand-
pose good-manufacturing-practice regula.
tions this year to govern the quality of ma-
ard simply to require the her-
terials, parts and processing of pacemakers.
metic sealing of all implanted
In addition, he said that the National Bu-
pacemakers is necessary or
reau of Standards has developed new test
wise," his letter said. "Moreo-
and evaluation methods.
ver, it could introduce other
Responding to Sen. Ribicoff's suggestión
problems which would ad-
that the Navy standard should have been
vesely affect the present util-
adopted, the Secretary said manufacturers
ity of pacemakers.'
have been hermetically sealing semiconduc-
Secretary Weinberger said it
tor devices since the early 19603. The entire
often is difficult to determine
unit can't be sealed. however, because mer-
whether a pacemaker failure
cury batteries produce hydrogen gas that
resulted in death or injury. He
must be released, be said.
said pacemaker patients range
from infants with congenital
defects to elderly persons suf-
fering from arteriosclerosis,
Wall Street Jour.
"all whose hearts are defecuve
April 8, 1975, P. 1
and whose deaths often are not
Defective cardise paremakers have et
unexpected."
rectly contributed to eight deaths of treast
He provided Senator Ribicoff
patients in the past three years and 13 others
with the following list of pace-
deaths are under investigation, Health, Eac-
maker deaths and injuries:
cation and Welfare Secretary Weinberger
General Electric recall of
told c congressional committee looking into
the matter.
574 units in early 1972. four
THE SECRETARY OF HEALTH. EDUCATION, AND WELFARE
DEPARTMENT
WASHINGTON. D.C. 20201
Cipil 975
MEMORANDUM FOR THE PRESIDENT
FROM
: CASPAR W. WEINBERGER CNW
SUBJECT: Medical Device Legislation
OMB has advised us of your decision not to re-propose to the Congress
legislation which the Administration previously sponsored if such
legislation would cost additional resources not specifically included
in your 1976 budget, even though it may be mentioned in the budget.
One legislative proposal which is in this category and which I wish
to bring to your attention involves authority to regulate medical
devices. The circumstances surrounding this piece of legislation
are such that you may wish us to support it even though it may be
viewed by some as an exception to your general rule. Actually, I
do not believe it requires an exception to that rule; it can and
should be a no-cost proposal this year, and therefore need not be
"caught in the net" of that rule.
The legislation would provide the Food and Drug Administration with
needed authority to establish mandatory standards for medical devices,
require premarket scientific review in certain cases, and control
investigational devices. We have sought sensible legislation in this
field in order to preclude such problems as defertive pacemakers,
implanted heart valves, kidney dialysis machines, and potentially
dangerous intrauterine devices. Because of the critical nature of
these devices even a very small error rate results in significant
human tragedy, and so this new legislation is clearly in the
"humanitarian" category.
The problem in not supporting medical device legislation this year is
greater than just the fact that the Administration has supported this
legislation in the past two Congresses. Prior to your decision the
Food and Drug Commissioner, in testimony this year before the Congress,
has used our medical device legislation and its prospective trans-
mission to the Congress as a basis for heading off other undesirable
legislation. He offered such testimony in good faith, believing that
legislation would soon be transmitted based on oir past support. It
is reasonably clear that the Congress will pass some legislation on
medical devices this session no matter what we say. But failure of
the Administration to take a positive position or this legislation
would place the Department in an awkward position at best.
DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE
2
Because I both understand and agree with your strong position to
hold down Federal expenditures, I think we cannot proceed with
this proposal in a "business as usual" fashion. We could, however,
take the position that we favor enactment of this legislation this
year with the understanding that implementation in FY 1976 would
be conducted within resources already budgeted for the Food and
Drug Administration. Given the circumstances in this case, I would
prefer to proceed in this fashion if you agree.
I have attached at Tab A a copy of my draft letter to Senator Scott
on the pending medical devices bill. The letter favors enactment
this year but indicates an intention to implement within available
resources in 1976. The letter to Senator Scott does state, correctly,
that additional resources will be required in Fiscal 1977.
Recommendation
I recommend that you endorse our support of a medical devices bill
but at no additional FY 1976 cost.
Decision
Support medical devices bill but
at no additional FY 1976 cost
DO not support medical devices bill
Attachment
CC: Dr. Cooper - H
Samuel/Sopper - L
Dr. Altman - P
P:WAMorrill/mrj
4-2-75
REVISED:CWWeinberger/mrj
4-3-75
FILE
OFFICE
SURNAME
DATE
OFFICE
SURNAME
DATE
OFFICE
SURNAME
D.
COPY
Honorable Hugh Scott
Minority Leader
Uinited States Senate
Washington, D. C. 20510
Dear llugh:
There is before the Senate, as reported by the Committee on Labor and
Public Welfare, S. 510, the "Medical Device Amendments of 1975. "
The reported bill is identical with S. 2368, which was passed by the
Senate during the 93rd Congress, providing the Food and Drug Adminis-
tration (FDA) with a number of new authorities relating to medical
devices. S. 510 would enable the establishment of mandatory standards,
require premarket scientific review in certain cases, and control
investigational devices. It would also require manufacturers to
register, maintain records, make reports, notify FDA of defective
products, and comply with good manufacturing practice regulations.
We have certain objections to the reported bill, as discussed below.
One of the principal issues of medical device legislation concerns
what types of devices should be subject to scientific review.
Page 2 - Honorable Hugh Scott
S. 510 provides that devices that are life-sustaining or life-supporting
must be classified as requiring premarket scientific review even if
standards or an exemption would be adequate. We believe this provision
is too broad and that the following alternative language would be
preferable to the first sentence of proposed section 514 (a) (1) of the
Act.
SEC. 514. (a) (1) The Secretary may declare that a device (or
type or class of device) for which scientific review has been
determined to be appropriate pursuant to section 511 (d) shall
be subject to scientific review under this section with respect
to any particular use or intended use thereof, if, after consul-
tation with the appropriate panel or panels specified in sub-
section (b), he finds that (A) insufficient information exists
(i) to assure effectiveness or (ii) to assure that exposure to
such devices will not cause unreasonable risk of illness or
injury and (B) scientific review may assure effectiveness or
may reduce or eliminate such unreasonable risk and (c) no more
practicable means to assure effectiveness or to reduce or eliminate
the unreasonable risk are appropriate and (D) the device purports
or is represented to be for a use which is of substantial
importance in supporting, sustaining, or preventing impairment
of human life or health
Conforming amendments would be needed in proposed section 511 of the Act
regarding criteria for classification of medical devices, including
Page 3 - Honorable Hugh Scott
deletion of the last sentence in proposed section 511 (c) (1) (B)
The Department also opposes the provision in the bill concerning pro-
tection of human subjects in device investigations. The excessive
specificity of this language would freeze into law the current
requirements of Department policy, and thereby interfere with its
further administrative updating to keep pace with developments in
biomedical technology.
As you are aware, the Department supported legislation similar to
S. 510 in the 93rd Congress. If amended to meet the objections
outlined above, the Department also supports enactment of S. 510.
FDA's existing Bureau of Medical Devices and Diagnostic Products would
be charged with carrying out the responsibilities created by the
bill's enactment. Because of the President's decision not to initiate
new spending programs this year, the Bureau would begin to implement
a strengthened medical devices regulation program within FDA's
current resources. Additional resources necessary to implement
enacted legislation would be requested in the President's Budget
for FY 1977.
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.
Sincerely,
Secretary