Safe Medical Devices Act of 1990
PL 101-629 (H.R.3095), enacted 11/28/1990

PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4511 
Public Law 101-629 
101st Congress 
An Act 
To amend the Federal Food, Drug, and C!osmetic Act to make improvements in the 
regulation of medical devices, and for other purposes. 
Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, 
SECTION 1. SHORT TITLE AND REFERENCE TO ACT. 
(a) SHORT TITLE.—This Act may be cited as the "Safe Medical 
Devices Act of 1990". 
0?) REFERENCE.—Whenever in this Act (other than in section 19) 
an amendment 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 provision of the Federal 
Food, Drug, and Cosmetic Act. 
SEC. 2. USER REPORTS. 
(a) REQUIREMENT.—Section 519 (21 U.S.C. 360i) is amended by 
redesignating subsection (b) as subsection (c) and by inserting after 
subsection (a) the following: 
"User Reports 
"(b)(1)(A) Whenever a device user facility receives or otherwise 
becomes aware of information that reasonably suggests that there is 
a probability that a device has caused or contributed to the death of 
a patient of the facility, the facility shall, as soon as practicable but 
not later than 10 working days after becoming aware of the informa-
tion, report the information to the Secretary and, if the identity of 
the manufacturer is known, to the manufacturer of the device. In 
the case of deaths, the Secretary may by regulation prescribe a 
shorter period for the reporting of such information. 
"(B) Whenever a device user facility receives or otherwise becomes 
aware of information that reasonably suggests that there is a prob-
ability that a device has caused or contributed to the serious illness 
of, or serious injury to, a patient of the facility, the facility shall, as 
soon as practicable but not later than 10 working days after becom-
ing aware of the information, report the information to the manu-
facturer of the device or to the Secretary if the identity of the 
manufacturer is not known. 
"(C) Each device user facility shall submit to the Secretary on a 
semi-annual basis a summary of the reports made under subpara-
graphs (A) and (B). Such summary shall be submitted on January 1 
and July 1 of each year. The summary shall be in such form and 
contain such information from such reports as the Secretary may 
require and shall include— 
"(i) sufficient information to identify the facility which made 
the reports for which the summary is submitted, 
"(ii) in the case of any product which was the subject of a 
report, the product name, serial number, and model number. 
Nov. 28, 1990 
[H.R. 3095] 
Safe Medical 
Devices Act of 
1990. 
Health care. 
21 u s e 301 note. 
104 STAT. 4512 
PUBLIC LAW 101-629—NOV. 28, 1990 
"(iii) the name and the address of the manufacturer of such 
device, and 
"(iv) a brief description of the event reported to the manufac-
turer. 
The Secretary may by regulation alter the frequency and timing of 
reports required by this subparagraph. 
"(D) For purposes of subparagraphs (A), (B), and (C), a device user 
facility shall be treated £is having received or otherwise become 
aware of information with respect to a device of that facility when 
medical personnel who are employed by or otherwise formally 
affiliated with the facility receive or otherwise become aware of 
information with respect to that device in the course of their duties. 
"(2) The Secretary may not disclose the identity of a device user 
facility which makes a report under paragraph (1) except in connec-
tion with— 
"(A) an action brought to enforce section 301(q), 
"(B) a communication to a manufacturer of a device which is 
the subject of a report under paragraph (1), or 
"(C) a disclosure required under subsection (a). 
This paragraph does not prohibit the Secretary from disclosing the 
identity of a device user facility making a report under paragraph 
(1) or any information in such a report to employees of the Depart-
ment of Health and Human Services, to the Department of Justice, 
or to the duly authorized committees and subcommittees of the 
Congress. 
"(3) No report made under paragraph (1) by— 
"(A) a device user facility, 
"(B) an individual who is employed by or otherwise formally 
affiliated with such a facility, or 
"(C) a physician who is not required to make such a report, 
shall be admissible into evidence or otherwise used in any civil 
action involving private parties unless the facility, individual, or 
physician who made the report had knowledge of the falsity of the 
information contained in the report. 
"(4) A report made under paragraph (1) does not affect any 
obligation of a manufacturer who receives the report to file a report 
as required under subsection (a). 
"(5) For purposes of this subsection: 
"(A) The term 'device user facility' means a hospital, ambula-
tory surgical facility, nursing home, or outpatient treatment 
facility which is not a physician's office. The Secretary may by 
regulation include an outpatient diagnostic facility which is not 
a physician's office in such term. 
"(B) The terms 'serious illness' and 'serious injury' mean 
illness or injury, respectively, that— 
"(i) is life threatening, 
"(ii) results in permanent impairment of a body function 
or permanent damage to a body structure, or 
"(iii) necessitates immediate medical or surgical interven-
tion to preclude permanent impairment of a body function 
or permanent damage to a body structure.". 
21 use 360i 
(b) REGULATIONS.—The Secretary of Health and Human Services 
shall promulgate regulations to implement section 519(b) of the 
Federal Food, Drug, and Cosmetic Act, as added by the amendment 
made by subsection (a) (including a definition of the summary 
required by paragraph (1)(C) of such section) not later than 12 
months after the date of enactment of this Act. In promulgating the 
note. 
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4513 
regulations, the Secretary shall minimize the administrative bur-
dens on device user facilities consistent with the need to assure 
adequate information. 
(c) EFFECTIVE DATE.—Section 519(b) of the Federal Food, Drug, and 21 use 360i 
Cosmetic Act, as added by the amendment made by subsection (a), ^°*^-
shall take effect— 
(1) upon the effective date of regulations promulgated under 
subsection (b), or 
(2) upon the expiration of 12 months from the date of the 
enactment of this Act, 
whichever occurs first. 
(d) EDUCATION AND INFORMATION.—During the 18-month period 21 use 360i 
beginning on the date of the enactment of this Act, the Secretary of ^°^' 
Health and Human Services shall inform device user facilities (as 
defined in section 519(bX5)(A) of the Federal Food, Drug, and Cos-
metic Act) and manufacturers and distributors of devices respecting 
the requirements of section 519(b) of such Act. Additionally, the 
Secretary, to the extent practicable, shall provide persons subject to 
the requirements of such section assistance in the form of publica-
tions regarding such requirements. 
(e) STUDY.—Not more than 36 months after the date of the enact- 21 USC 360i 
ment of this Act, the Comptroller General of the United States shall "°*®-
conduct a study o
f
— 
(1) the compliance by device user facilities (as defined in 
section 519(b)(5)(A) of the Federal Food, Drug, and Cosmetic Act) 
with the requirements of section 519(b) of such Act, 
(2) the actions taken by the manufacturers of devices in 
response to reports made to them under such section, 
(3) the cost effectiveness of such requirements and their 
implementation, and 
(4) any recommendations for improvements to such require-
ments. 
The Comptroller General shall complete the study and submit a 
report on the study not later than 45 months from the date of the 
enactment of this Act. The report shall be submitted to the Commit-
tee on Energy and Commerce of the House of Representatives and 
the Committee on Labor and Human Resources of the Senate and to 
the Secretary of Health and Human Services, 
if) REPORT TO CONGRESS.—Not later than 36 months after the date 21 USe 360i 
of enactment of this Act, the Secretary of Health and Human "°^-
Services shall prepare and submit to the appropriate committees of 
Congress a report that contains an evaluation of the requirements of 
section 519(b) of the Federal Food, Drug, and Cosmetic Act. In 
preparing the report, the Secretary shall consult with individuals 
and organizations with an interest in health care and consumer 
issues. At a minimum, the report shall contain— 
(1) an evaluation of the safety benefits of the requirements, 
(2) an evaluation of the burdens placed on the Food and Drug 
Administration and on device user facilities by the require-
ments, 
(3) an evaluation of the cost-effectiveness of the requirements, 
and 
(4) recommendations for legislative reform. 
SEC. 3. REPORTS. 
(a) DISTRIBUTOR REPORTS.— 
104 STAT. 4514 
PUBLIC LAW 101-629—NOV. 28, 1990 
(1) Section 519(a) (21 U.S.C. 360i(a)) is amended by striking out 
"and" at the end of paragraph (4), by striking out the period at 
the end of paragraph (5) and inserting in lieu thereof "; and", 
and by adding after paragraph (5) the following: 
"(6) shall require distributors who submit such reports to 
submit copies of the reports to the manufacturer of the device 
for which the report was made.". 
Effective date. 
(2) Section 519(a)(6), as added by the amendment made by 
21 use 360i 
paragraph (1), shall take effect upon the effective date of final 
regulations under subsection (c). 
(b) CERTIFICATION, DEVICE TRACKING.— 
(1) Section 519 (21 U.S.C. 360i), as amended by section 2, is 
amended by adding at the end the following: 
"Certification 
"(d) Each manufacturer, importer, and distributor required to 
make reports under subsection (a) shall submit to the Secretary 
annually a statement certifying that— 
"(1) the manufacturer, importer, or distributor did file a 
certain number of such reports, or 
"(2) the manufacturer, importer, or distributor did not file 
any report under subsection (a). 
"Device Tracking 
"(e) Every person who registers under section 510 and is engaged 
in the manufacture o
f
— 
"(1) a device the failure of which would be reasonably likely to 
have serious adverse health consequences and which is (A) a 
permanently implantable device, or (B) a life sustaining or life 
supporting device used outside a device user facility, or 
"(2) any other device which the Secretary may designate, 
shall adopt a method of device tracking.". 
(2) Section 520(j) (21 U.S.C. 360j(j)) is amended by striking out 
"No" and inserting in lieu thereof "Except as provided in 
section 519(e), no". 
Effective 
(3) Section 519(e), as added by the amendment made by 
9?*fTGr- Qcn- 
paragraph (1), shall take effect upon the effective date of final 
note 
regulations under subsection (c). 
21 use 360i 
(c) REGULATIONS.— 
note. 
(1)(A) Not later than 9 months after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall 
issue proposed regulations— 
Records. 
(i) to require distributors of devices to establish and 
maintain records and to make reports (including reports 
required by part 803 of title 21 of the Code of Federal 
Regulations) under section 519(a)(6) of the Federal Food, 
Drug, and Cosmetic Act, and 
(ii) to implement section 519(e) of such Act. 
The Secretary may exempt from regulations described in clause 
(i) classes of distributors of class I and class II devices from 
whom reports are not necessary for the protection of the public 
health. 
(B) Regulations under subparagraph (A) shall— 
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4515 
(i) require appropriate methods for maintenance of 
records to ensure that patients who receive devices can be 
provided the notification required by such Act, 
(ii) require that manufacturers adopt effective methods of 
tracking devices, 
(iii) take into account the position of distributors in the 
device distribution process, and 
(iv) include such other requirements as the Secretary 
deems necessary for the adoption of an effective user track-
ing program under section 519(e) of such Act. 
(2) Not later than 18 months after the date of the enactment 
of this Act, the Secretary shall issue final regulations to imple-
ment sections 519(a)(6) and 519(e) of the Federal Food, Drug, and 
Cosmetic Act. If the Secretary does not promulgate such final 
regulations upon the expiration of such 18 months, the Congress 
finds that there is good cause for the proposed regulations to be 
considered as the final regulations without response to com-
ment because the implementation of sections 519(a)(6) and 
519(e) of such Act are essential to protect the health of patients 
who use such devices. Consequently, in such event, the proposed 
regulations issued under paragraph (1) shall become final regu-
lations as of the expiration of such 18 months. There shall be Federal 
promptly published in the Federal Register notice of the new pubiic|[-on 
status of the proposed regulations. 
SEC. 4. SUBSTANTIAL EQUIVALENCE; CLASSIFICATION REVISION. 
(a) SUBSTANTIAL EQUIVALENCE.—Section 513(f) (21 U.S.C. 360c(f)) is 
amended by adding at the end the following: 
"(3) If a manufacturer reports to the Secretary under section 
510(k) that a device is substantially equivalent to another device— 
"(i) which the Secretary has classified as a class III device 
under subsection (b), 
"(ii) which was introduced or delivered for introduction into 
interstate commerce for commercial distribution before Decem-
ber 1,1990, and 
"(iii) for which no final regulation requiring premarket ap-
proval has been promulgated under section 5150b), 
the manufacturer shall certify to the Secretary that the manufac-
turer has conducted a reasonable search of all information known or 
otherwise available to the manufacturer respecting such other 
device and has included in the report under section 510(k) a sum-
mary of and a citation to all adverse safety and effectiveness data 
respecting such other device and respecting the device for which the 
510(k) report is being made and which has not been submitted to the 
Secretary under section 519. The Secretary may require the manu-
facturer to submit the adverse safety and effectiveness data de-
scribed in the report.". 
(b) REVISION OF CLASSIFICATION.— 
(1) Section 515 (21 U.S.C. 360e) is amended by adding at the 
end the following: 
"Revision 
"(i)(l) Before December 1, 1995, the Secretary shall by order 
require manufacturers of devices, which were introduced or deliv-
ered for introduction into interstate commerce for commercial dis-
104 STAT. 4516 
PUBLIC LAW 101-629—NOV. 28, 1990 
Regulations. 
Federal 
Register, 
publication. 
Regulations. 
Regulations. 
Federal 
Register, 
publication. 
Regulations. 
tribution before May 28, 1976, and which are subject to revision of 
classification under paragraph (2), to submit to the Secretary a 
summary of and citation to any information known or otherwise 
available to the manufacturer respecting such devices, including 
adverse safety or effectiveness information which has not been 
submitted under section 519. The Secretary may require the manu-
facturer to submit the adverse safety or effectiveness data for which 
a summary and citation were submitted, if such data are available 
to the manufacturer. 
"(2) After the issuance of an order under paragraph (1) but before 
December 1, 1995, the Secretary shall publish a regulation in the 
Federal Register for each device— 
"(A) which the Secretary has classified as a class III device, 
and 
"(B) for which no final regulation has been promulgated 
under section 515(b), 
revising the classification of the device so that the device is classi-
fied into class I or class II, unless the regulation requires the device 
to remain in class III. In determining whether to revise the classi-
fication of a device or to require a device to remain in class III, the 
Secretary shall apply the criteria set forth in section 513(a). Before 
the publication of a regulation requiring a device to remain in class 
III or revising its classification, the Secretary shall publish a pro-
posed regulation respecting the classification of a device under this 
paragraph and provide reasonable opportunity for the submission of 
comments on any such regulation. No regulation requiring a device 
to remain in class III or revising its classification may take effect 
before the expiration of 90 days from the date of its publication in 
the Federal Register as a proposed regulation. 
"(3) The Secretary shall, as promptly as is reasonably achievable, 
but not later than 12 months after the effective date of the regula-
tion requiring a device to remain in class III, establish a schedule for 
the promulgation of a section 515(b) regulation for each device 
which is subject to the regulation requiring the device to remain in 
class III.". 
(2) Section 520(1) (21 U.S.C. 360j(l)) is amended by adding at 
the end the following: 
"(5)(A) Before December 1, 1991, the Secretary shall by order 
require manufacturers of devices described in paragraph (1), which 
are subject to revision of classification under subparagraph (B), to 
submit to the Secretary a summary of and citation to any informa-
tion known or otherwise available to the manufacturers respecting 
the devices, including adverse safety or effectiveness information 
which has not been submitted under section 519. The Secretary may 
require a manufacturer to submit the adverse safety or effectiveness 
data for which a summary and citation were submitted, if such data 
are available to the manufacturer. 
"(B) Except as provided in subparagraph (C), after the issuance of 
an order under subparagraph (A) but before December 1, 1992, the 
Secretary shall publish a regulation in the Federal Register for each 
device which is classified in class III under paragraph (1) revising 
the classification of the device so that the device is classified into 
class I or class II, unless the regulation requires the device to remain 
in class III. In determining whether to revise the classification of a 
device or to require a device to remain in class III, the Secretary 
shall apply the criteria set forth in section 513(a). Before the publica-
tion of a regulation requiring a device to remain in class III or 
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4517 
revising its classification, the Secretary shall publish a proposed 
regulation respecting the classification of a device under this 
subparagraph and provide an opportunity for the submission of 
comments on any such regulation. No regulation under this 
subparagraph requiring a device to remain in class III or revising its 
classification may take effect before the expiration of 90 days from 
the date of the publication in the Federal Register of the proposed 
regulation. 
"(C) The Secretary may by notice published in the Federal Reg-
ister extend the period prescribed by subparagraph (B) for a device 
for an additional period not to exceed 1 year.". 
(3)(A) Notwithstanding section 520(1)(5) of the Federal Food, 21 use 360c 
Drug, and Cosmetic Act, the Secretary of Health and Human "°**' 
Services shall not retain any daily wear soft or daily wear 
nonhydrophilic plastic contact lens in class III under such Act 
unless the Secretary finds that it meets the criteria set forth in 
section 513(a)(lXC) of such Act. The finding and the grounds for Federal 
the finding shall be published in the Federal Register. For any Re^^r, 
such lens, the Secretary shall make the determination respect- ^" 
ing reclassification required in section 520(1)(5)(B) of such Act 
within 24 months of the date of the enactment of this 
paragraph. 
(B) The Secretary of Health and Human Services may by 
notice published in the Federal Register extend the two-year 
period prescribed by subparagraph (A) for a lens for an addi-
tional period not to exceed one year. 
(C)(i) Before classifying a lens in class II pursuant to subpara-
graph (A), the Secretary of Health and Human Services shall 
pursuant to section 513(a)(1)(B) of such Act assure that appro-
priate regulatory safeguards are in effect which provide reason-
able assurance of the safety and effectiveness of such lens, 
including clinical and preclinical data if deemed necessary by 
the Secretary. 
(ii) Prior to classifying a lens in class I pursuant to subpara-
graph (A), the Secretary shall assure that appropriate regu-
latory safeguards are in effect which provide reasonable 
assurance of the safety and effectiveness of such lens, including 
clinical and preclinical data if deemed necessary by the 
Secretary. 
(D) Notwithstanding section 520(1X5) of such Act, if the Sec-
retary of Health and Human Services has not made the finding 
and published the finding required by subparagraph (A) within 
36 months of the date of the enactment of this subparagraph, 
the Secretary shall issue an order placing the lens in class II. 
(E) Any person adversely affected by a final regulation under 
this paragraph revising the classification of a lens may chal-
lenge the revision of the classification of such lens only by filing 
a petition under section 513(e) for a classification change. 
SEC. 5. CLASSIFICATION AND RECLASSIFICATION OF DEVICES. 
(a) STANDARDS.— 
(1) Section 513(aXlXAXii) (21 U.S.C. 360c(aXlXAXii)) is amend-
ed by striking out "or to establish a performance standard" and 
inserting in lieu thereof "or to establish special controls". 
(2) Section 513(aXlXB) (21 U.S.C. 360c(aXlXB)) is amended to 
read as follows: 
104 STAT. 4518 
PUBLIC LAW 101-629—NOV. 28, 1990 
"(B) CLASS II, SPECIAL CONTROLS.—A device which cannot be 
clEissified as a class I device because the general controls by 
themselves are insufficient to provide reasonable assurance of 
the safety and effectiveness of the device, and for which there is 
sufficient information to establish special controls to provide 
such assurance, including the promulgation of performance 
standards, postmarket surveillance, patient registries, develop-
ment and dissemination of guidelines (including guidelines for 
the submission of clinical data in premarket notification 
submissions in accordance with section 510(k)), recommenda-
tions, and other appropriate actions as the Secretary deems 
necessary to provide such assurance. For a device that is pur-
ported or represented to be for a use in supporting or sustaining 
human life, the Secretary shall examine and identify the special 
controls, if any, that are necessary to provide adequate assur-
ance of safety and effectiveness and describe how such controls 
provide such assurance.". 
(3) Clause (i) of section 513(a)(1)(C) (21 U.S.C. 360c(a)(l)(C)) is 
amended to read as follows: 
"(i) it (I) cannot be classified as a class I device because 
insufficient information exists to determine that the ap-
plication of general controls are sufficient to provide 
reasonable assurance of the safety and effectiveness of the 
device, and (II) cannot be classified as a class II device 
because insufficient information exists to determine that 
the special controls described in subparagraph (B) would 
provide reasonable assurance of its safety and effectiveness, 
and". 
(b) CLASSIFICATION CHANGE.—Section 513(e) (21 U.S.C. 360c(e)) is 
amended by redesignating clauses (1) and (2) as clauses (A) and (B), 
respectively, and by inserting "(1)" after "(e)" and by adding at the 
end the following: 
"(2) By regulation promulgated under paragraph (1), the Secretary 
may change the classification of a device from class III— 
"(A) to class II if the Secretary determines that special con-
trols would provide reasonable assurance of the safety and 
effectiveness of the device and that general controls would not 
provide reasonable assurance of the safety and effectiveness of 
the device, or 
"(B) to class I if the Secretary determines that general con-
trols would provide reasonable assurance of the safety and 
effectiveness of the device.". 
(c) F.D.A. AUTHORITY TO INITIATE RECLASSIFICATION.— 
(1) Section 513(f)(2)(A) (21 U.S.C 360c(f)(2)(A)) is amended by 
striking out "The manufacturer" and inserting in lieu thereof 
"The Secretary may initiate the reclassification of a device 
classified into class III under paragraph (1) of this subsection or 
^ll6 IH£Lll.llf£LC^U.]T61* 
(2) Section 520(1)(2) (21 U.S.C. 360j(l)(2)) is amended by striking 
out "The manufacturer" and inserting in lieu thereof "The 
Secretary may initiate the reclassification of a device classified 
into class III under paragraph (1) of this subsection or the 
manufacturer''. 
(3) The heading for section 513(f) (21 U.S.C. 360c(f)) is amended 
by inserting "and Reclassification" before "of. 
publication. 
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4519 
SEC. 6. ESTABLISHMENT OF PERFORMANCE STANDARDS. 
(a) PROCEDURE.—Section 514 (21 U.S.C. 360d) is amended— 
(1) in subsection (a), by amending the first sentence to read as 
follows: "The special controls required by section 513(a)(lXB) 
shall include performance standards for a class II device if the 
Secretary determines that a performance standard is necessary 
to provide reasonable assurance of the safety and effectiveness 
of the device.", 
(2) by striking out subsections (b) through (f), 
(3) by redesignating subsection (g) as subsection (b), 
(4) in subsection (b) (as redesignated), by amending para-
graphs (1) and (2) to read as follows: 
"(IXA) The Secretary shall publish in the Federal Register a ^^™^ 
notice of proposed rulemaking for the establishment, amendment, or ^^^Jj„ 
revocation of any performance standard for a device. 
"(B) A notice of proposed rulemaking for the establishment or 
amendment of a performance standard for a device shall— 
"(i) set forth a finding with supporting justification that the 
performance standard is appropriate and necessary to provide 
reasonable assurance of the safety and effectiveness of the 
device, 
"(ii) set forth proposed findings with respect to the risk of 
illness or injury that the performance standard is intended to 
reduce or eliminate, 
"(iii) invite interested persons to submit to the Secretary, 
within 30 days of the publication of the notice, requests for 
changes in the classification of the device pursuant to section 
513(e) based on new information relevant to the classification, 
and 
"(iv) invite interested persons to submit an existing perform-
ance standard for the device, including a draft or proposed 
performance standard, for consideration by the Secretary. 
"(C) A notice of proposed rulemaking for the revocation of a 
performance standard shall set forth a finding with supporting 
justification that the performance standard is no longer necessary to 
provide reasonable assurance of the safety and effectiveness of a 
device. 
"(D) The Secretary shall provide for a comment period of not less 
than 60 days. 
"(2) If, after publication of a notice in accordance with paragraph 
(1), the Secretary receives a request for a change in the classification 
of the device, the Secretary shall, within 60 days of the publication 
of the notice, after consultation with the appropriate panel under 
section 513, either deny the request or give notice of an intent to 
initiate such change under section 513(e).". 
(b) CONFORMING AMENDMENTS.— 
(1) Section 514(b) (as redesignated by subsection (aX3)) is 
amended— 
(A) in paragraph (3XA), by striking out "paragraph (2)" 
and inserting in lieu thereof "paragraph (1)", and 
(B) in paragraph (4XA), by striking out "paragraphs (2) 
and (3XB)" and inserting in lieu thereof "paragraphs (1), (2), 
and (3XB)". 
(2) Section 520(i) (21 U.S.C. 360j(i)) is amended by striking out 
"514(gX5XB)" and inserting in lieu thereof "514(bX5XB)". 
39-194 O - 91 - 5 : QL 3 Part 6 
104 STAT. 4520 
PUBLIC LAW 101-629—NOV. 28, 1990 
SEC. 7. REPORTS OF REMOVALS AND CORRECTIONS. 
Section 519 (21 U.S.C. 360i), as amended by sections 2 and 3, is 
amended by adding at the end the following: 
"Reports of Removals and Corrections 
"(fKD Except as provided in paragraph (2), the Secretary shall by 
regulation require a manufacturer, importer, or distributor of a 
device to report promptly to the Secretary any correction or removal 
of a device undertaken by such manufacturer, importer, or distribu-
tor if the removal or correction was undertaken— 
"(A) to reduce a risk to health posed by the device, or 
"(B) to remedy a violation of this Act caused by the device 
which may present a risk to health. 
A manufacturer, importer, or distributor of a device who undertakes 
a correction or removal of a device which is not required to be 
reported under this paragraph shall keep a record of such correction 
or removal. 
"(2) No report of the corrective action or removal of a device may 
be required under paragraph (1) if a report of the corrective action 
or removal is required and has been submitted under subsection (a). 
"(3) For purposes of paragraphs (1) and (2), the terms 'correction' 
and 'removal' do not include routine servicing.". 
SEC. 8. RECALL AUTHORITY. 
Section 518 (21 U.S.C. 360h).is amended by adding at the end the 
following new subsection: 
"Recall Authority 
"(eXD If the Secretary finds that there is a reasonable probability 
that a device intended for human use would cause serious, adverse 
health consequences or death, the Secretary shall issue an order 
requiring the appropriate person (including the manufacturers, 
importers, distributors, or retailers of the device)— 
"(A) to immediately cease distribution of such device, and 
"(B) to immediately notify health professionals and device 
user facilities of the order and to instruct such professionals and 
facilities to cease use of such device. 
The order shall provide the person subject to the order with an 
opportunity for an informal hearing, to be held not later than 10 
days after the date of the issuance of the order, on the actions 
required by the order and on whether the order should be amended 
to require a recall of such device. If, after providing an opportunity 
for such a hearing, the Secretary determines that inadequate 
grounds exist to support the actions required by the order, the 
Secretary shall vacate the order. 
"(2)(A) If, after providing an opportunity for an informal hearing 
under paragraph (1), the Secretary determines that the order should 
be amended to include a recall of the device with respect to which 
the order was issued, the Secretary shall, except as provided in 
Reports. 
subparagraphs (B) and (C), amend the order to require a recall. The 
Secretary shall specify a timetable in which the device recall will 
occur and shall require periodic reports to the Secretary describing 
the progress of the recall. 
"(B) An amended order under subparagraph (A)— 
"(i) shall— 
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4521 
"(I) not include recall of a device from individuals, and 
"(II) not include recall of a device from device user facili-
ties if the Secretary determines that the risk of recalling 
such device from the facilities presents a greater health 
risk than the health risk of not recalling the device from 
use, and 
"(ii) shall provide for notice to individuals subject to the risks 
associated with the use of such device. 
In providing the notice required by clause (ii), the Secretary may use 
the assistance of health professionals who prescribed or used such a 
device for individuals. If a significant number of such individuals 
cannot be identified, the Secretary shall notify such individuals 
pursuant to section 705(b). 
"(3) The remedy provided by this subsection shall be in addition to 
remedies provided by subsections (a), (b), and (c).". 
SEC. 9. TEMPORARY SUSPENSION OF APPROVAL OF APPLICATION. 
(a) SUSPENSION.—Section 515(e) (21 U.S.C. 360e(e)) is amended— 
(1) by adding at the end the following: 
"(3) If, after providing an opportunity for an informal hearing, the 
Secretary determines there is reasonable probability that the 
continuation of distribution of a device under an approved applica-
tion would cause serious, adverse health consequences or death, the 
Secretary shall by order temporarily suspend the approval of the 
application approved under this section. If the Secretary issues such 
an order, the Secretary shall proceed expeditiously under paragraph 
(1) to withdraw such application.", and 
(2) in the subsection heading, by inserting "and Temporary 
Suspension" after "Withdrawal". 
(b) CONFORMING AMENDMENT.—Section 501(f) (21 U.S.C. 351(f) is 
amended— 
(1) in subpar^aph (A)(iiXII), bv striking out "or withdrawn" 
and inserting in lieu thereof 
, suspended, or withdrawn", 
(2) in subparagraph (BXii), by striking out "which does not 
have such an application in effect" and inserting in lieu thereof 
"which has an application which has been suspended or is 
otherwise not in effect", and 
(3) in subparagraph (C), by striking out "which does not have 
such an application in effect" and inserting in lieu thereof 
"which has an application which has been suspended or is 
otherwise not in effect". 
SEC. 10. POSTMARKET SURVEILLANCE. 
Subchapter A of chapter 5 is amended by inserting after section 
521 (21 U.S.C. 360k) the following new section: 
"POSTMARKET SURVEILLANCE 
"SEC. 522. (a) IN GENERAL.— 
21 use 360/. 
"(1) REQUIRED SURVEILLANCE.—The Secretary shall require a 
manufacturer to conduct postmarket surveillance for any device 
of the manufacturer first introduced or delivered for introduc-
tion into interstate commerce after January 1, 1991, that— 
"(A) is a permanent implant the failure of which may 
cause serious, adverse health consequences or death, 
"(B) is intended for a use in supporting or sustaining 
human life, or 
104 STAT. 4522 
PUBLIC LAW 101-629—NOV. 28, 1990 
"(C) potentially presents a serious risk to human health. 
"(2) DISCRETIONARY SURVEILLANCE.—The Secretary may 
re-
quire a manufacturer to conduct postmarket surveillance for a 
device of the manufacturer if the Secretary determines that 
postmarket surveillance of the device is necessary to protect the 
public health or to provide safety or effectiveness data for the 
device. 
"(b) SURVEILLANCE APPROVAL.—Each manufacturer required to 
conduct a surveillance of a device under subsection (a) shall, within 
30 dajrs of the first introduction or delivery for introduction of such 
device into interstate commerce submit, for the approval of the 
Secretary, a protocol for the required surveillance. Tlie Secretary, 
within 60 days of the receipt of such protocol, shall determine if the 
principal investigator proposed to be used in the surveillance has 
sufQcient qualifications and experience to conduct such surveillance 
and if such protocol will result in collection of useful data or other 
information necessary to protect the public health and to provide 
safety and effectiveness information for the device. The Secretary 
may not approve such a protocol until it has been reviewed by an 
appropriately qualified scientific and technical review committee 
established by the Secretary.". 
SEC. 11. USE OF PREMARKET APPROVAL DATA. 
Section 520 (21 U.S.C. 360j) is amended— 
(1) in subsection (c)— 
(A) by striking out "under section 513 from class III to 
class II and inserting in lieu thereof "from class III to class 
II or class I", and 
(B) by inserting "(1) in accordance with subsection (h), 
and (2)'' after "except", and 
(2) in subsection (h)— 
(A) in paragraph (3), by striking out "Any" and inserting 
in lieu thereof "Except as provided in paragraph (4), any', 
and 
(B) by adding at the end the following new paragraph: 
"(4XA) Any information contained in an application for premarket 
approval filed with the Secretary pursuant to section 515(c), includ-
ing clinical and preclinical tests or studies, but excluding descrip-
tions of methods of manufacture and product composition, that 
demonstrates the safety and effectiveness of a device shall be avail-
able 1 year sifter the original application for the fourth device of a 
kind has been approved by the Secretary, for use by the Secretary in 
approving devices, or determining whether a product development 
protocol has been completed, under section 515, establishing a 
performance standard under section 514, and reclassifying devices 
under subsections (e) and (f) of section 513, and subsection (1X2). The 
Secretary shall deem devices that incorporate the same tech-
nologies, have the same principles of operation, and are intended for 
the same use or uses to be within a kind of device. 
^^•"^ 
"(B) The Secretary, contemporaneously with the approval of the 
w^^tion 
fourth device of a kind, shall publish an order in the Federal 
Register identif3ring the four devices of a kind that have been 
approved under section 515 and the date on which the data con-
tained in premarket approval applications for the devices will be 
available to the Secretary for use, as described in subparagraph (A). 
"(C) The publicly available detailed summaries of information 
respecting the safety and effectiveness of devices required by para-
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4523 
Effective date. 
Federal 
Register, 
publication. 
graph (IXA) shall be available for use by the Secretary as the 
evidentiary basis for the regulatory action described in subpara-
graph (A). 
"(DXi) This paragraph shall become effective— 
"(I) on November 15, 1990, for devices for which four devices 
of a kind were approved on or before December 31, 1987, and 
"(11) on November 15, 1991, for devices not described in 
subclause (I). 
"(ii) For each device described in clause (iXD, the Secretary shall 
publish a notice in the Federal Register setting forth the date, which 
shall be not earlier than 1 year after the date of the notice, that data 
identified in subparagraph (A) shall be available for the use of the 
Secretary. 
"(EXi) Except £is provided in clause (ii), the approval date of a 
device, for purposes of this paragraph, shall be the date of the letter 
of the Secretary to the applicant approving a device under section 
515 and permitting the applicant to commercially distribute the 
device. 
"(ii) For each device described in subparsigraph (DXDdD for which 
the original application for a fourth device of a kind is approved by 
the Secretary before November 1, 1991, the approval date of the 
fourth device of a kind shall be deemed to be November 15, 1991. 
"(F) Any challenge to an order under subparagraph (B) shall be 
made not later than 30 days after the date of the Federal Register 
notice referred to in such subparagraph.". 
SEC. 
12. 
SUBSTANTIAL EQUIVALENCE. 
(a) SUBSTANTIAL EQUIVALENCE.—Section 513 (21 U.S.C. 360j) is 21 use 360c. 
amended by adding at the end the following new subsection: 
"Substantial Equivalence 
"(iXlXA) For purposes of determinations of substantial equiva-
lence under subsection (f) and section 520(1), the term 'substantially 
equivalent' or 'substantial equivalence' means, with respect to a 
device being compared to a predicate device, that the device has the 
same intended use as the predicate device and that the Secretary by 
order has found that the device— 
"(i) has the same technological characteristics as the predi-
cate device, or 
"(iiXD has different technological characteristics and the 
information submitted that the device is substantially equiva-
lent to the predicate device contains information, including 
clinical data if deemed necessary by the Secretory, that dem-
onstrates that the device is as safe and effective as a legally 
marketed device, and (II) does not raise different questions of 
safety and efficacy than the predicate device. 
"(B) For purposes of subparagraph (A), the term 'different techno-
logical characteristics' means, with respect to a device being com-
pared to a predicate device, that there is a significant change in the 
materials, design, energy source, or other features of the device from 
those of the predicate device. 
"(2) A device may not be found to be substantially equivalent to a -
predicate device that has been removed from the market at the 
initiative of the Secretary or that has been determined to be mis-
branded or adulterated by a judicial order. 
104 STAT. 4524 
PUBLIC LAW 101-629—NOV. 28, 1990 
"(3)(A) As part of a submission under section 510(k) respecting a 
device, the person required to file a premarket notification under 
such section shall provide an adequate summary of any information 
respecting safety and effectiveness or state that such information 
will be made available upon request by any person. 
Public 
"(B) Any summary under subparagraph (A) respecting a device 
information. 
shall Contain detailed information regarding data concerning ad-
verse health effects and shall be made available to the public by the 
Secretary within 30 days of the issuance of a determination that 
such device is substantially equivalent to another device.". 
21 use 360c 
0>) REGULATIONS.—Within 12 months of the date of the enactment 
note. 
of this Act, the Secretary of Health and Human Services shall issue 
regulations establishing the requirements of the summaries under 
section 513(iX3) of the Federal Food, Drug, and Cosmetic Act, as 
added by the amendment made by subsection (a). 
SEC. 13. JUDICIAL REVIEW. 
Section 517(a) (21 U.S.C. 360g(a)) is amended— 
(1) by striking out "or" at the end of paragraph (6), and 
(2) by inserting after paragraph (7) the following new para-
graphs: 
"(8) an order pursuant to section 513(i), 
"(9) a regulation under section 515(iX2) or 520(1X5XB), or 
"(10) an order under section 520(cX4XB),". 
SEC. 14. HUMANITARIAN DEVICE EXEMPTION. 
(a) EXEMPTION.—Section 520 (21 U.S.C. 360j) is amended by adding 
at the end the following: 
"Humanitarian Device Exemption 
"(mXl) To the extent consistent with the protection of the public 
health and safety and with ethical standards, it is the purpose of 
this subsection to encourage the discovery and use of devices in-
tended to benefit patients in the treatment and diagnosis of diseases 
or conditions that affect fewer than 4,000 individuals in the United 
States. 
"(2) The Secretary may grant a request for an exemption from the 
effectiveness requirements of sections 514 and 515 for a device for 
which the Secretary finds that— 
"(A) the device is designed to treat or diagnose a disease or 
condition that affects fewer than 4,000 individuals in the United 
States, 
"(B) the device would not be available to a person with a 
disease or condition referred to in subparagraph (A) unless the 
Secretary grants such an exemption and there is no comparable 
device, other than under this exemption, available to treat or 
diagnose such disease or condition, and 
"(C) the device will not expose patients to an unreasonable or 
signihcant risk of illness or injury and the probable benefit to 
health from the use of the device outweighs the risk of injury or 
illness from its use, taking into account the probable risks and 
benefits of currently available devices or alternative forms of 
treatment. 
"(3) No person granted an exemption under paragraph (2) with 
respect to a device may sell the device for an amount that exceeds 
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4525 
the costs of research and development, fabrication, and distribution 
of the device. 
"(4) Devices granted an exemption under paragraph (2) may only 
be used— 
"(A) in facilities that have established, in accordance with 
regulations of the Secretary, a local institutional review 
committee to supervise clinical testing of devices in the facili-
ties, and 
"(B) if, before the use of a device, an institutional review 
committee approves the use in the treatment or disignosis of a 
disease or condition referred to in paragraph (2)(A). 
"(5) An exemption under paraigraph (2) shall be for a term of 18 
months and may only be initially granted in the 5-year period 
beginning on the date regulations under paragraph (6) take effect. 
The Secretary may extend such an exemption for a period of 18 
months if the Secretary is able to make the findings set forth in 
paragraph (2) and if the applicant supplies information demonstrat-
ing compliance with paragraph (3). An exemption may be extended 
more than once and may be extended after the expiration of such 5-
year period. 
"(6) Within one year of the date of the enactment of this subsec- Regulations, 
tion, the Secretary shall issue regulations to implement this sub-
section.". 
(b) EFFECTIVE DATE.—Subsection (m) of section 520 of the Federal 
21 use 360j 
Food, Drug, and Cosmetic Act, as added by the amendment made by 
^°^-
subsection (a), shall take effect on the effective date of the regula-
tions issued by the Secretary under paragraph (6) of such subsection. 
(c) REPORT.—Within 4 years after the issuance of regulations 
21 use 360j 
under section 520(mX6) of the Federal Food, Drug, and Cosmetic Act, note. 
as added by the amendment made by subsection (a), the Secretary of 
Health and Human Services shall report to the Congress (1) on the 
types of devices exempted under such section, (2) an evaluation of 
the effects of such section, and (3) a recommendation on extension of 
the section. 
SEC. 15. ESTABLISHMENT 
OF 
THE 
OFFICE 
OF 
INTERNATIONAL 
RELATIONS. 
(a) OFFICE.—Title VIII is amended by adding at the end the 
following: 
"OFFICE OF INTERNATIONAL RELATIONS 
"SEC. 803. (a) There is established in the Department of Health 
21 USe 383. 
and Human Services an Office of International Relations. 
"(h) In carrjdng out the functions of the office under subsection (a), 
the Secretary may enter into agreements with foreign countries to 
facilitate commerce in devices between the United States and such 
countries consistent with the requirements of this Act. In such 
agreements, the Secretary shall encourage the mutual recognition 
of— 
"(1) good manufacturing practice regulations promulgated 
under section 520(f), gind 
"(2) other regulations and testing protocols as the Secretary 
determines to be appropriate." 
(b) REPORT.—Not later than 2 years after the date of the enact- 
21 USe 383 note, 
ment of this Act, the Secretary of Health and Human Services shall 
prepare and submit to the appropriate committees of Congress a 
104 STAT. 4526 
PUBLIC LAW 101-629—NOV. 28, 1990 
report on the activities of the Office of International Relations 
under section 803 of the Federal Food, Drug, and Cosmetic Act, 
added by subsection (a). 
SEC. 16. REVIEW OF MARKET APPLICATIONS FOR ARTICLES COMPRISING 
COMBINATIONS OF DRUGS, DEVICES, AND BIOLOGICS. 
(a) REVIEW.—Section 503 (21 U.S.C. 353) is amended— 
(1) by striking out the section heading and inserting in lieu 
thereof the following: 
"EXEMPTIONS AND CONSIDERATION FOR CERTAIN DRUGS, DEVICES, AND 
BIOLOGICAL PRODUCTS", 
and 
(2) by adding at the end the following: 
"(fKD The Secretary shall designate a component of the Food and 
Drug Administration to regulate products that constitute a combina-
tion of a drug, device, or biological product. The Secretary shall 
determine the primary mode of action of the combination product. If 
the Secretary determines that the primary mode of action is that 
of— 
"(A) a drug (other than a biological product), the persons 
charged with premarket review of drugs shall have primary 
jurisdiction, 
"(B) a device, the persons charged with premarket review of 
devices shall have primary jurisdiction, or 
"(C) a biological product, the persons charged with premarket 
review of biological products shall have primary jurisdiction. 
"(2) Nothing in this subsection shall prevent the Secretary from 
using any agency resources of the Food and Drug Administration 
necessary to ensure adequate review of the safety, effectiveness, or 
substantial equivalence of an article. 
Regulations. 
"(3) The Secretary shall promulgate regulations to implement 
market approval procedures in accordance with paragraphs (1) and 
(2) not later than 1 year after the date of enactment of this sub-
section. 
"(4) As used in this subsection: 
"(A) The term 'biological product' has the meaning given the 
term in section 351(a) of the Public Health Service Act (42 
U.S.C. 262(a)). 
"(B) The term 'market clearance' includes— 
"(i) approval of an application under section 505, 507, 515, 
or 520(g), 
"(ii) a finding of substantial equivalence under this sub-
chapter, and 
"(iii) approval of a product or establishment license under 
subsection (a) or (d) of section 351 of the Public Health 
Service Act (42 U.S.C. 262).". 
flj) DEFINITIONS.—Section 201 (21 U.S.C. 321) is amended— 
(1) in paragraph (g)(1), by striking out "; but does not include 
devices or their componente, parts, or accessories", and 
(2) in paragraph (h)(3), by striking out "any of its principal" 
and inserting in lieu thereof "its primary". 
SEC. 17. CIVIL PENALTIES. 
(a) AMENDMENT.—Section 303 (21 U.S.C. 333) is amended by 
adding at the end the following: 
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4527 
"(fKlXA) Except as provided in subparagraph (B), any person who 
violates a requirement of this Act which relates to devices shall be 
liable to the United States for a civil penalty in an amount not to 
exceed $15,000 for each such violation, and not to exceed $1,000,000 
for all such violations adjudicated in a single proceeding. 
"(B) SubparEigraph (A) shall not apply— 
"(i) to any person who violates the requirements of section 
519(a) or 520(f) unless such violation constitutes (I) a significant 
or knowing departure from such requirements, or (II) a risk to 
public health, 
"(ii) to any person who commits minor violations of section 
519(e) or 519(f) (only with respect to correction reports) if such 
person demonstrates substantial compliance with such section, 
or 
"(iii) to violations of section 501(aX2)(A) which involve one or 
more devices which are not defective. 
"(2)(A) A civil penalty under paragraph (1) shall be assessed by the 
Secretary by an order made on the record after opportunity for a 
hearing provided in accordance with this subparagraph and section 
554 of title 5, United States Code. Before issuing such an order, the 
Secretary shall give written notice to the person to be assessed a 
civil penalty under such order of the Secretary's proposal to issue 
such order and provide such person an opportunity for a hearing on 
the order. In the course of any investigation, the Secretary may 
issue subpoenas requiring the attendance and testimony of wit-
nesses and the production of evidence that relates to the matter 
under investigation. 
"(B) In determining the amount of a civil penalty, the Secretary 
shall take into account the nature, circumstances, extent, and grav-
ity of the violation or violations and, with respect to the violator, 
ability to pay, effect on ability to continue to do business, any 
history of prior such violations, the degree of culpability, and such 
other matters as justice may require. 
"(C) The Secretary may compromise, modify, or remit, with or 
without conditions, any civil penalty which may be assessed under 
paragraph (1). The amount of such penalty, when finally deter-
mined, or the amount agreed upon in compromise, may be deducted 
from any sums owing by the United States to the person charged. 
"(3) Any person who requested, in accordance with paragraph 
(2)(A), a hearing respecting the assessment of a civil penalty and 
who is aggrieved by an order assessing a civil penalty may file a 
petition for judicial review of such order with the United States 
CJourt of Appeals for the District of Columbia Circuit or for any 
other circuit in which such person resides or transacts business. 
Such a petition may only be filed within the 60-day period beginning 
on the date the order making such assessment was issued. 
"(4) If any person fails to pay an assessment of a civil penalty— 
"(A) after the order making the assessment becomes final, 
and if such person does not file a petition for judicial review of 
the order in accordance with paragraph (3), or 
"(B) after a court in an action brought under paragraph (3) 
has entered a final judgment in favor of the Secretary, 
the Attorney General shall recover the amount assessed (plus in-
terest at currently prevailing rates from the date of the expiration 
of the 60-day period referred to in paragraph (3) or the date of such 
final judgment, as the case may be) in an action brought in any 
appropriate district court of the United States. In such an action, 
104 STAT. 4528 
PUBLIC LAW 101-629—NOV. 28, 1990 
the v£ilidity, amount, and appropriateness of such penalty shall not 
be subject to review.". 
Reports. 
(b) EFFECTIVE D A T E OF APPUCATION TO DEVICE USER FACILITIES.— 
21 use 333 note. 
(1) The Secretary of Health and Human Services shall con-
duct a study to determine whether there has been substantial 
compliance with the requirements of section 519(b) of the Fed-
eral Food, Drug, and (Emetic Act by device user facilities (as 
defined in section 519(bX5XA) of such Act). The Secretary shall 
report the results of the study to the Congress after the expira-
tion of 45 months after the date of the enactment of this Act. 
(2XA) If upon the expiration of 48 months after the date of the 
enactment of this Act the Secretary has not made the report 
required by paragraph (1), section 303(f) of the Federal Food, 
Drug, and Cosmetic Act, as added by the amendment made by 
subsection (a), shall take effect with respect to device user 
facilities (as defined in section 519(b)(5XA) of such Act). 
(B) If in the report under paragraph (1) the Secretary reports 
that there has been substantial compliance with the require-
ments of such section 519(b) by a type of device user facility and 
if the Secretary does not make a determination under subpara-
graph (C) with respect to such type of facility, such section 303(f) 
shall not take effect with respect to such type of facility. 
(C) If the Secretary determines in the report under paragraph 
(1) that there is not substantial compliance with the require-
ments of such section 519(b) by a type of device user facility or if 
the Secretary makes such a determination after making the 
report under paragraph (1), such section 303(f) shall take effect 
with respect to such type of facility upon the effective date of 
the report. 
SEC. 18. MISCELLANEOUS. 
(a) SECTION 513(f).—Section 513(fK2) (21 U.S.C. 360c(f)(2)) is 
amended in subparagraph (B)(i), by striking out "the Secretary 
shall" and inserting in lieu thereof "the Secretary may for good 
cause shown". 
(b) SECTION 514.—Section 514(b) (21 U.S.C. 360d(bX4XB)) (as so 
redesignated) is amended— 
(1) in paragraph (3XB) (as so redesignated), by striking out ", 
after affording all interested persons an opportunity for an 
informal hearing,", and 
(2) in clause (ii) of paragraph (4)(A) (as so redesignated), by 
striking out "unless" and all that follows in that clause and 
inserting in lieu thereof the following: "which demonstrates 
good cause for referral and which is made before the expiration 
of the period for submission of comments on such proposed 
regulation refer such proposed regulation,". 
(c) SECTION 515.—Section 515(cX2) (21 U.S.C. 360e(cX2)) is amended 
by striking out "paragraph (1), the Secretary shall refer such 
application' and inserting in lieu thereof "paragraph (1), the 
Secretary— 
"(A) may on the Secretary's own initiative refer such applica-
tion, or 
"(B) shall, upon the request of an applicant unless the Sec-
retary finds that the information in the application which 
would be reviewed by a panel substantially duplicates informa-
tion which has previously been reviewed by a panel appointed 
under section 513. 
refer such application . 
PUBLIC LAW 101-629—NOV. 28, 1990 
104 STAT. 4529 
(d) SECTION 516.—Section 516(a) (21 U.S.C. 360f(a)) is amended (1) 
by striking out "and after consultation with the appropriate panel 
or panels under section 513", and (2) by striking out the last 
' 
sentence 
(e) SECTION 520(f).—Section 520(f)(lXA) (21 U.S.C. 360j(f)(l)(A)) is 
amended by inserting "pre-production design validation (including a 
process to assess the performance of a device but not including an 
evaluation of the safety or effectiveness of a device)," after 
"manufacture,". 
(f) 
SECTION 520(1).—Section 520(1X2) (21 U.S.C. 360j(lX2)) is 
amended by striking out "and after affording the petitioner an 
opportunity for an informal hearing". 
SEC. 19. ELECTRONIC PRODUCTS. 
(a) IN GENERAL.— 
(1) Subpart 3 of part F of title III of the Public Health Service 
Act is amended as follows: 
42 USC prec. 
(A) The heading for the subpart is amended to read as ^^^''• 
follows: 
"SUBCHAPTER C—ELECTRONIC PRODUCT RADIATION CONTROL". 
(B) The subpart is amended by striking out "subpart" ^L^J^q 
each place it occurs and inserting in lieu thereof "sub- 263b-263n, 
chapter". 
(2XA) Section 356 of such Act is amended— 
42 use 263d. 
(i) by striking out "358" each place it occurs and inserting 
in lieu thereof "534", and 
(ii) by striking out "sections 3648 and 3709 of the Revised 
Statutes of the United States (31 U.S.C. 529, 41 U.S.C. 5)" 
and inserting in lieu thereof "section 3324 of title 31, 
United States Code, and section 3709 of the Revised Stat-
utes of the United States (41 U.S.C. 5)". 
(B) Section 358(aXlXE) of such Act is amended by striking out 
42 USC 263f. 
"355" and inserting in lieu thereof "531". 
(C) Section 359 of such Act is amended— 
42 USC 263g. 
(i) by striking out "358" each place it occurs and inserting 
in lieu thereof "534", and 
(ii) by striking out "360A" each place it occurs and insert-
ing in lieu thereof "537". 
(D) Section 360 of such Act is amended by striking out "358" 42 USC 263h. 
each place it occurs and inserting in lieu thereof "534". 
(E) Section 360A of such Act is amended— 
42 USC 263i. 
(i) by striking out "358" and inserting in lieu thereof 
"534", and 
(ii) by striking out "359" each place it occurs and insert-
ing in lieu thereof "535". 
(F) Section 360B of such Act is amended— 
42 USC 263j. 
(i) by striking out "358" each place it occurs and inserting 
in lieu thereof "534", 
(ii) by striking out "359" each place it occurs and insert-
ing in lieu thereof "535", and 
(iii) by striking out "360A" each place it occurs and 
inserting in lieu thereof "537". 
(G) Section 360C of such Act is amended— 
42 USC 263k. 
104 STAT. 4530 
PUBLIC LAW 101-629—NOV. 28, 1990 
42 u s e 263n. 
Repeal. 
42 u s e 263b. 
42 u s e 263c-
263n. 
42 use 
263b-263n. 
21 use 
360gg-3608s. 
42 u s e prec. 
262. 
21 u s e 360hh. 
(i) by striking out "358" and inserting in lieu thereof 
"534", 
(ii) by striking out "360B" each place it occurs and insert-
ing in lieu thereof "538", and 
(iii) by striking out "360F" and inserting in lieu thereof 
"542". 
(H) Section 360F of such Act is amended by striking out "358" 
and inserting in lieu thereof "534". 
(3) Section 354 of such Act is repealed and sections 355 
through 360F of such Act are redesignated as sections 531 
through 542, respectively. 
(4) Subpart 3 of part F of title III of the Public Health Service 
Act, as amended by paragraphs (1) and (2) of this subsection, is 
transferred to chapter V of the Federal Food, Drug, and Cos-
metic Act and is placed after section 528 and sections 354 
through 360F of such subpart are redesignated as sections 530 
through 542 of the Federal Food, Drug, and Cosmetic Act, 
respectively. 
(b) CONFORMING AMENDMENT.—The heading for part F of title III 
of the Public Health Service Act is amended by striking out "AND 
CONTROL OF RADIATION". 
(c) CONSTRUCTION.—The transfer of subpart 3 of part F of title III 
of the Public Health Service Act to the Federal Food, Drug, and 
Cosmetic Act does not change the application of the requirements of 
such subpart and such Act to electronic products which were in 
effect on the date of the enactment of this Act. 
Approved November 28, 1990. 
LEGISLATIVE HISTORY—H.R. 3095 (S. 3006): 
HOUSE REPORTS: No. 101-808 (eomm. on Energy and eommerce) and No. 101-959 
(eomm. of eonference). 
SENATE REPORTS: No. 101-513 accompanying S. 3006 (Coram, on Labor and Huraan 
Resources). 
C O N G R E S S I O N A L RECORD, Vol. 136 (1990): 
Oct. 10, considered and passed House. 
Oct. 12, H.R. 3095 considered and passed Senate, amended, in lieu of S. 3006. 
Oct. 26, House agreed to conference report. 
Oct. 27, Senate agreed to conference report.