I
104TH CONGRESS
2D SESSION
H. R. 3201
To amend the Federal Food, Drug, and Cosmetic Act to facilitate the develop-
ment, clearance, and use of devices to maintain and improve the public
health and quality of life of the citizens of the United States.
IN THE HOUSE OF REPRESENTATIVES
MARCH 29, 1996
Mr. BARTON of Texas (for himself, Mr. GREENWOOD, Mr. RICHARDSON, Mr.
BILIRAKIS, Mr. HALL of Texas, Mr. GORDON, Mr. BURR, Ms. ESHOO,
Mr. COBURN, Mr. BREWSTER, Mr. KLUG, Mr. DOOLEY of California, Mr.
GANSKE, Mr. MCHALE, Mr. BILBRAY, Mr. PAYNE of Virginia, Mr.
OXLEY, Mr. HOLDEN, Mr. FIELDS of Texas, Mr. PAXON, Mr. SCHAEFER,
Mr. TAUZIN, Mr. FOX of Pennsylvania, Mr. UPTON, Mr. CAMPBELL, Mr.
MCINTOSH, Mr. COX of California, Mr. DREIER, Mr. HEINEMAN, Mr.
FUNDERBURK, Mr. WELDON of Florida, Mr. HOSTETTLER, Mr. SHAYS,
Mr. HASTERT, Mr. NORWOOD, Mr. BURTON of Indiana, Mr. FRAZER,
Mr. STEARNS, Mr. FRISA, Mr. RAMSTAD, Mr. MARTINI, and Ms. DUNN
of Washington) introduced the following bill; which was referred to the
Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
facilitate the development, clearance, and use of devices
to maintain and improve the public health and quality
of life of the citizens of the United States.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CON-
TENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Medical Device Reform Act of 1996’’.
(b) REFERENCE.—Whenever in this Act an amend-
ment or repeal is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference
shall be considered to be made to a section or other provi-
sion of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
(c) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title; reference; table of contents.
Sec. 2. FDA mission and annual report.
Sec. 3. Dispute resolution.
Sec. 4. Investigational device exemptions.
Sec. 5. Special review for certain devices.
Sec. 6. Expanding humanitarian use of devices.
Sec. 7. Performance standards.
Sec. 8. Effectiveness determination.
Sec. 9. Premarket notification.
Sec. 10. Classification panels.
Sec. 11. Premarket approval.
Sec. 12. Accreditation of third parties.
Sec. 13. Reclassification of preamendment devices.
Sec. 14. Device tracking.
Sec. 15. Postmarket surveillance.
Sec. 16. Harmonization.
Sec. 17. Good manufacturing practice inspections.
Sec. 18. Use of scientific and medical information.
Sec. 19. Reports.
Sec. 20. G.M.P. and device reports.
Sec. 21. Civil penalties.
Sec. 22. Information system.
Sec. 23. Environmental impact review.
Sec. 24. Informal agency statements.
Sec. 25. Research and education; practice of medicine.
Sec. 26. Publication of notice of deviation.
SEC. 2. FDA MISSION AND ANNUAL REPORT.
(a) MISSION.—Section 903 (21 U.S.C. 393) is
amended by redesignating subsections (b) and (c) as sub-
sections (c) and (d), respectively, and by adding after sub-
section (a) the following:
‘‘(b) MISSION.—The Food and Drug Administration
shall protect the public health and safety and promptly
and efficiently review and approve clinical research and
marketing of products in a manner that does not unduly
impede innovation or product availability. The Food and
Drug Administration shall participate with other countries
to reduce the burden of regulation, harmonize regulatory
requirements, and achieve appropriate reciprocal arrange-
ments.’’
(b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393),
as amended by subsection (a), is amended by adding at
the end the following:
‘‘(e) ANNUAL REPORT.—The Secretary shall, simul-
taneously with the submission each year of the budget for
the Food and Drug Administration, submit to the Com-
mittee on Commerce of the House of Representatives and
the Committee on Labor and Human Resources of the
Senate an annual report which shall—
‘‘(1) review the performance of the Food and
Drug Administration in meeting its mission and the
development of Food and Drug Administration poli-
cies to implement such mission;
‘‘(2) review the performance of the Food and
Drug Administration in meeting its own perform-
ance standards, including its own outcome measure-
ments and statutory deadlines for the approval of
products or for other purposes contained in this Act;
‘‘(3) describe the staffing and resources of the
Food and Drug Administration and list those per-
sons and organizations accredited to conduct inves-
tigations under section 505(1), product approvals
under sections 505 and 506, and to perform good
manufacturing 
practice 
reviews 
under 
section
505(d)(3) and 520(f);
‘‘(4) describe the goals, activities, and accom-
plishments of the Food and Drug Administration in
bilateral and multinational meetings that addressed
methods and approaches to reduce the burden of
regulation, harmonize regulation, and to seek appro-
priate reciprocal arrangements, list each such meet-
ing, and list pending issues specifying those that are
not consistent with or are contrary to the provisions
of this Act; and
‘‘(5) compare the performance of the Food and
Drug Administration in approving innovative prod-
ucts with that of the most successful agencies per-
forming similar functions in other countries and
compare the resources used by such agencies.’’.
SEC. 3. DISPUTE RESOLUTION.
Chapter V is amended by adding after section 522
the following:
‘‘DISPUTE RESOLUTION
‘‘SEC. 523. (a) At any time before the issuance of
the notice under section 510(k) or an exemption for inves-
tigational use under section 520(g) for a device, the appli-
cant may, in writing, notify the Secretary that an impasse
exists in the review of the application for a device under
section 515 or the submission for such an exemption with
respect to a specifically identified issue.
‘‘(b) On receipt of the notification from the applicant,
the Secretary shall refer the disputed issue—
‘‘(1) to an existing (as of the date of the notifi-
cation) scientific advisory panel having expertise re-
lated to the issue;
‘‘(2) to a special Government employee, as de-
fined in section 202(a) of title 18, United States
Code, or to a non-governmental person qualified to
mediate or arbitrate the substance of such impasse
who is acceptable to the Secretary and the applicant.
‘‘(c) The applicant and representatives of the Sec-
retary may consult with the panel, special Government em-
ployee, or non-governmental person on the matter re-
ferred. The panel, special Governmental employee, or non-
governmental person shall submit to the Secretary and the
applicant a report containing recommendations (including
a statement of reasons for the recommendations) regard-
ing the matter not later than 60 days after the date of
the referral, or not later than 90 days after the date of
the referral if the panel, special Governmental employee,
or non-governmental person considers the additional 30
days to be necessary. Not later than 30 days after the
date of receiving the report, the Secretary shall, in writing,
confirm or modify the recommendations received, provid-
ing reasons and reference to data before the panel, special
Governmental employee, or non-governmental person for
any modification. If the Secretary fails to act on such a
recommendation within 30 days of its receipt, the rec-
ommendation of the panel, special Government employee,
or non-governmental person shall be deemed to be the rec-
ommendation of the Secretary.
‘‘(d) The Federal Advisory Committee Act shall not
apply to any scientific advisory panel acting under this
section.’’.
SEC. 4. INVESTIGATIONAL DEVICE EXEMPTIONS.
Section 520(g) (21 U.S.C. 360j(g)) is amended by
adding at the end the following:
‘‘(6) The Secretary shall, by regulation and within
120 days of the date of the enactment of this paragraph,
update the procedures and conditions under which devices
intended for human use may upon application be granted
an exemption from certain requirements of this Act. Such
regulation shall—
‘‘(A) permit the use of investigational devices,
outside of an investigational protocol, in the diag-
nosis or treatment of diseases or conditions that are
life-threatening or could be irreversibly debilitating
when the risk of not using the investigational device
exceeds the probable risk of using such device as de-
termined by the treating physician;
‘‘(B) ensure that prior to submitting an appli-
cation to the Secretary or to an institutional review
board, any person intending to investigate the safety
or effectiveness of a class III device or an implant
device will have the opportunity to submit an inves-
tigational plan, including a clinical protocol, to the
Secretary for review;
‘‘(C) within 30 days of receipt of an investiga-
tional plan under subparagraph (B), require the Sec-
retary to respond in writing to the submitter identi-
fying each deficiency with the plan and such other
information that will facilitate the review and ap-
proval of an application;
‘‘(D) provide a submitter who disputes the Sec-
retary’s response under subparagraph (C) a right to
appear before a classification panel constituted
under section 513(b), at the next scheduled panel
meeting, and obtain the review by the panel of the
investigational plan and the Secretary’s evaluation of
such plan;
‘‘(E) permit developmental changes in devices
in response to information gathered during the
course of an investigation without requiring an addi-
tional approval of an application for an investiga-
tional device exemption, or the approval of a supple-
ment to such an application, if such changes do not
constitute a significant change in design or a signifi-
cant change in basic principles of operation; and
‘‘(F) without additional approval of an applica-
tion for an investigational device exemption, or the
approval of a supplement to such an application,
permit changes or modifications to clinical protocols
that do not affect the validity of data or information
resulting from the completion of an approved proto-
col and do not alter the relationship of likely patient
risk to benefit relied upon to approve a protocol.’’.
SEC. 5. SPECIAL REVIEW FOR CERTAIN DEVICES.
Section 515(d) is amended by adding at the end the
following:
‘‘(4) In order to better treat or diagnose life-threaten-
ing or irreversibly debilitating diseases or conditions of
man, the Secretary shall promulgate a regulation to create
review priority for devices—
‘‘(A) representing breakthrough technologies,
‘‘(B) for which no approved alternatives exist,
‘‘(C) which offer significant advantages over ex-
isting approved alternatives, or
‘‘(D) the availability of which is in the best in-
terest of the public health.
Such regulation shall include, among other things, criteria
identifying devices which merit preferential review, speci-
fying procedures for implementing such reviews, and iden-
tifying substantive review criteria appropriate to making
prompt and efficient review of such devices. The Secretary
shall publish in the Federal Register a proposed regulation
to create such review priority no later than 6 month after
the date of the enactment of this paragraph, allowing 60
days for comment. The Secretary will publish a final regu-
lation no later than 60 days after the last day of the com-
ment period.’’.
SEC. 6. EXPANDING HUMANITARIAN USE OF DEVICES.
Section 520(m) (21 U.S.C. 360j(m)) is amended—
(1) in paragraph (2), by inserting after and
below subparagraph (C) the following: ‘‘The request
shall be in the form of an application to the Sec-
retary. Within 30 days of the date of the receipt of
an application, the Secretary shall issue an order ap-
proving or denying the application.’’; and
(2) by striking paragraphs (5) and (6).
SEC. 7. PERFORMANCE STANDARDS.
Section 514 (21 U.S.C. 360d) is amended to read as
follows:
‘‘STANDARDS
‘‘SEC. 514. (a) The Secretary shall, through publica-
tion in the Federal Register, issue notices recognizing ap-
plicable nationally or internationally recognized consensus
standards in any determination as to whether there is a
reasonable assurance that a device is safe or effective or
to determine compliance with any requirement of this Act.
Any person may elect to utilize data other than that re-
quired by such standards to demonstrate a reasonable as-
surance of device safety or effectiveness or compliance
with the requirements of this Act.
‘‘(b) The Secretary shall accept certifications that de-
vices conform with each type of standard referenced in
subsection (a) and identified in each such certification.’’.
SEC. 8. EFFECTIVENESS DETERMINATION.
Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amend-
ed—
(1) in subparagraph (A), by inserting ‘‘one or
more’’ after ‘‘on the basis of’’ and by striking ‘‘clini-
cal investigations’’ and inserting ‘‘a clinical inves-
tigation’’; and
(2) by adding at the end of subparagraph (A)
the following: ‘‘A well-controlled clinical investiga-
tion—
‘‘(i) shall not be considered appropriate unless
the Secretary determines, after consultation with a
classification panel established under subsection (b),
that such investigation is necessary to demonstrate
that the device will have the effect it purports or is
represented to have under the conditions of use pre-
scribed, recommended, or suggested in the labeling
of the device; and
‘‘(ii) shall only include methods of control that
are appropriate to the disease or condition for which
a device is intended as prescribed, recommended, or
suggested in the labeling of the device.
Any person may submit a well-controlled clinical investiga-
tion to the Secretary to demonstrate that a device will
have the effect it purports or is represented to have under
the conditions of use prescribed, recommended, or sug-
SEC. 9. PREMARKET NOTIFICATION.
(a) SECTION 510.—Section 510 (21 U.S.C. 360) is
amended—
(1) in subsection (k), by inserting after ‘‘a de-
vice intended for human use’’ the following: ‘‘(other
than any device classified into class I under section
513 or 520 or any device classified into class II
under section 513 or 520 if such class II device has
been exempted from the requirements of this sub-
section under subsection (l))’’;
(2) in subsection (k), by striking ‘‘report to the
Secretary’’ and inserting ‘‘have the option of report-
ing to the Secretary or any person who is not an em-
ployee of the United States and who is accredited
under section 712(a)’’; and
(3) by adding the following after subsection (k):
‘‘(l) Within 30 days after the date of the enactment
of this subsection, the Secretary shall publish in the Fed-
eral Register a list of each type of class II device that
does not require a report under subsection (k) to provide
reasonable assurance of safety and effectiveness. Each
type of class II device listed by the Secretary shall be ex-
empt from the requirement to file a report under sub-
section (k) as of the date of the publication of the list
in the Federal Register. Beginning on the date that is 1
day after the date of the publication of the list, any person
may petition the Secretary to exempt a type of class II
device from the reporting requirement of subsection (k).
If the Secretary fails to respond to a petition within 120
days of receiving it, the petition shall be deemed to be
granted.’’.
(b) INITIAL CLASSIFICATION.—Section 513(f) (21
U.S.C. 360c(f)) is amended—
(1) in the second sentence of paragraph (1) by
striking the period at the end and inserting the fol-
lowing: ‘‘unless within 30 days of receiving an order
classifying the device into class III the individual
who submits a report under section 510(k) for such
device requests review and recommendation with re-
spect to the classification of the device by a classi-
fication panel established under subsection (b) and
a final order of classification from the Secretary.
After the request, a device classified into class III
under this paragraph shall not be deemed to be fi-
nally classified until a classification panel established
under subsection (b) reviews the request with re-
spect to the classification of the device and, within
60 days of the date of receiving the request, rec-
ommends to the Secretary a classification for the de-
vice based on the classification criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1).
Thereafter, the Secretary shall have 10 days to de-
termine by order the final classification of the device
by applying such criteria. If the Secretary fails to
issue such an order within such 10 days, the rec-
ommendation of the classification panel shall be
deemed to be the order of final classification of the
device issued by the Secretary.’’.
(2) by adding at the end the following:
‘‘(4)(A) Within 90 days of receiving a report required
under section 510(k) for devices identified as being sub-
stantially equivalent to a class II device, a person accred-
ited under section 712 to conduct reviews of such report
shall determine the initial classification under paragraph
(1)(A) of any such device which was not introduced or de-
livered for introduction into interstate commerce for com-
mercial distribution before the date of the enactment of
this subparagraph and shall submit such determination to
the Secretary. The accredited person shall immediately, by
registered mail, provide to the submitter of such report
a copy of the recommendation to the Secretary for an
order classifying the device. Such determination shall be
considered to be an order of the Secretary initially
classifying the device. If the accredited person determines
that the device should be classified into class III, such per-
son shall, immediately upon making such determination,
refer the report to the Secretary.
‘‘(B) Within 60 days of receiving a report required
under section 510(k) for a device identified as being sub-
stantially equivalent to a class III device, a person accred-
ited under section 712 to conduct reviews of such report
shall make a determination of the initial classification
under paragraph (1)(A) of any such device which was not
introduced or delivered for introduction into interstate
commerce for commercial distribution before the date of
the enactment of this subparagraph, and within such time
period submit a recommendation to the Secretary and to
the submitter of the report which contains such deter-
mination. The recommendation by such person of initial
classification of a device shall be considered to be an order
of the Secretary unless the Secretary, within 30 calendar
days of receipt of the recommendation, finds that the de-
vice is not substantially equivalent to a predicate device
and issues an order under this subsection initially
classifying the device. Such order shall be based on the
criteria in this subsection and subsection (i) and provide
a detailed explanation and justification for the basis of the
Secretary’s disagreement, if any, with the accredited per-
son’s recommendation. If, within 90 days from the date
of receipt of the report, the Secretary does not issue an
order that differs from the recommendation of the accred-
ited person, the Secretary shall promptly send by reg-
istered mail to the submitter of the report such rec-
ommendation as the Secretary’s order of initial classifica-
tion. If the Secretary does not provide the submitter such
recommendation by registered mail as specified, the rec-
ommendation of classification provided to the submitter
of the report shall become the Secretary’s order of initial
classification of the device. Such classification may only
be changed pursuant to the procedures specified in para-
graph (2) of this subsection.
‘‘(5) the Secretary may not withhold a determination
of the initial classification of a device under paragraph (1)
because of a failure to comply with any provision of this
Act unrelated to a substantial equivalence decision, includ-
ing a finding that the facility in which the device is manu-
factured is not in compliance with good manufacturing re-
quirements as set forth in regulations of the Secretary
under section 520(f).’’.
(c) SECTION 513(i).—Section 513(i) (21 U.S.C.
360c(i)) is amended—
(1) in paragraph (1)(A)(ii)(I), by striking ‘‘clin-
ical data’’ and inserting ‘‘either appropriate clinical
or scientific data’’ and by inserting ‘‘or a person ac-
credited under section 712’’ after ‘‘Secretary’’;
(2) in paragraph (1)(A)(ii)(II), by striking ‘‘ef-
ficacy’’ and inserting ‘‘effectiveness’’; and
(3) by adding at the end of paragraph (1) the
following:
‘‘(C) For purposes of subparagraph (A), the term ‘le-
gally marketed device’ includes any device introduced into
interstate commerce for commercial distribution before
May 28, 1976, and any device found substantially equiva-
lent to such device, which has not been removed from the
market by an order of the Secretary or a judicial order
because it is unsafe or ineffective.
‘‘(D) Any change or modification to a device, other
than a major change (including any major modification)
in the intended use, shall not require an additional submis-
sion under section 510(k) if such change or modification
is supported by appropriate data or information and the
change or modification can be shown to not adversely af-
fect the safety or effectiveness of the device which was in-
troduced in interstate commerce before May 28, 1976 or
initially classified under subsection (f). All data or infor-
mation relied upon to document that a change to (includ-
ing any modification of) such a device does not require
an additional report under section 510(k) shall be made
available to the Secretary upon request and maintained
for a period of time equal to at least the commercial life
of the device.
‘‘(E) For the purpose of determining the intended use
of a predicate device under subparagraph (A), each use
reasonably included within a general use for the predicate
device shall be deemed a legally marketed use of the predi-
cate device and shall be available for use in premarket re-
ports required under section 510(k).
‘‘(F) For the purpose of determining substantial
equivalence, the Secretary shall not consider any uses or
indications for use of a device that are not specifically
identified in a premarket market notification under section
510(k).
‘‘(G) For the purpose of determining substantial
equivalence the Secretary shall accept certification of com-
pliance with nationally or internationally recognized con-
sensus standards to resolve any substantial equivalence
issue which such standards address. To the extent that
a substantial equivalence issue is resolved by such stand-
ards, additional information shall not be required to fur-
ther address such an issue.’’.
SEC. 10. CLASSIFICATION PANELS.
Section 513(b) (21 U.S.C. 360c(b)) is amended by
adding at the end the following: