Medical Device Amendments of 1992
PL 102-300 (S.2783), enacted 06/16/1992

106 STAT. 238 
PUBUC LAW 102-300~-JUNE 16,1992 
Public Law 102-300 
102d Congress 
An Act 
June 16.1992 
[S. 2788] 
Medical Device 
Amendments 
of 1992. 
Safety. 
21 u s e 301 
note. 
Federal 
Register, 
publication. 
21USC360i 
note. 
To amend the Federal Food, Drug, and Cosmetic Act with respect to medical 
devices and for other purposes. 
Be it enacted by the Senate and House of Representatives of 
the United States cf 
America in Congress assembled, 
SECTION 1. SHORT TITLE AND REFERENCE. 
(a) SHORT TITLE.—^This Act may be cited as the 'Medical Device 
Amendments of 1992". 
(b) REFERENCE.—^Whenever in this Act 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. EFFECTIVE DATE AND REGULATIONS TO IBfPLEBIENT DEVICE 
TRACKING. 
(a) AMENDMENT.—Section 3 of the Safe Medical Devices Act of 
1990 (21 U.S.C. 360i note) is amended— 
(1) in subsection (bX3), by striking out "upon the effective 
date" and inserting in Ueu thereof "i^Mn tne expiration of 
9 months after the issuance"; 
(2) in subsection (cX2)— 
(A) by striking out "and 519(er the first place it occurs; 
and 
(B) by striking out "and 519(e) of sudi Act are" and 
inserting in Ueu uiereof 
"of such Act is"; and 
(3) by adding at the end of subsection (c) the following: 
"(3) Not later than November 28, 1992, the Secretaiy shall 
issue finsd regulations to implement section 519(e) of the Fed-
eral Food, Drue, and Cosmetic Act If the Secretaiy does not 
promulgate sucn final relations by November 28, 1992, the 
Congress finds that there is good cause for the proposed r^;ula-
tions to be considered as the final regulations without response 
to comment because the implementotion of section 519(e) of 
such Act is essential to protect the health of patients who 
use devices. In such event, the proposed regulations issued 
under paragraph (1) shall become the issued nnal regulations 
on NovemTOr 29, 1992. There shall be promptlv published 
in the Federal Register notice of the new status of the proposed 
ranilations.". 
(b) E
F
F
E
C
T
I
V
E DATE.—The amendments made by subsection (a) 
shall take effect as of May 27, 1992 and any rule to implement 
section 519(e) of the Federal Food, Drug, and Cosmetic Act proposed 
under section 3(cX2) of the Safe Medical Devices Act of 1990 shall 
revert to its proposed status as of such date. 
SBC. S. P08TMARKET SURVEILLANCE. 
(a) PROHIBITED ACT.— 
PUBLIC LAW 102-300—JUNE 16, 1992 
106 STAT. 239 
(1) IN GENERAL.—Section SOKqXD (21 U.S.C. 331(qXl)) is 
amended— 
(A) by striking out "
O
r (B)" and inserting in lieu thereof 
(B) by inserting before the period a comma and "or (C) 
comply with a requirement under section 522". 
(2) MiSBRANDED DEVICES.—Section 502(t) (21 U.S.C. 352(t)) 
is amended— 
(A) by striking out "or (2)" and inserting in lieu thereof 
"(2r; and 
(B) by inserting before the period a comma and "or (3) 
to comply with a requirement under section 522". 
(b) APPROVAL.—Section 5220)) (21 U.S.C. 3601(b)) is amended— 
(1) by striking out "(a)" and inserting in lieu thereof "(aXD*; 
(2) by inserting a comma after "commerce"; and 
(3) by adding after the first sentence the following: "Each 
manufacturer required to conduct a surveillance of a device 
under subsection (a)(2) shall, within 30 days after receiving 
notice that the manufacturer is required to conduct such sur-
veillance, submit, for the approval of the Secretary, a protocol 
for the required surveillance. . 
SEC. 
4
. 
REPAIR, 
BEPLACEMENT, 
OR 
SEFUND. 
Section 518(bXl)(AXii) (21 U.S.C. 360h(bXl)(AXii)) is amended 
by striking out "and" each place it occurs and inserting in lieu 
tnereof"oi^. 
SEC. S. REPORTING. 
(a) AMENDMENTS.—Section 519 (21 U.S.C. 360i) is amended— 
(1) by redesignating paragraphs (1) through (6) of subsection 
(a) as paragraphs (4) through (9), respective^, tmd by inserting 
before paragraph (4) (as so redesignated) the following: 
"(1) shall require a device manufacturer or importer to report 
to the Secretary whenever the manufacturer or importer 
receives or otherwise becomes aware of information that reason-
ably suggests that one of its marketed devices— 
"(A) may have caused or contributed to a death or serious 
injuiy, or 
"(B) has malftmctioned and that such device or a similar 
device marketed by the manufacturer or importer would 
be likely to cause or contribute to a death or serious injury 
if the malfunction were to recur; 
"(2) shall define the term 'serious injury* to mean an injury 
that^ 
"(A) is life threatening, 
"(B) results in permanent impairment of a body function 
or permanent damage to a body structure, or 
(C) necessitates medical or surgical intervention to pre-
clude permanent impairment of a Dody function or perma-
nent damage to a body structure; 
"(3) shall require reporting of other significant adverse device 
experiences as determined by the Secretary to be necessary 
to be reported;"; and 
(2) in subsection (b)— 
(A) in paragraph (1), by striking out "there is a prob-
ability that a device has" each place it occurs and inserting 
in lieu thereof "a device has or may have"; 
(B) in paragraph (1KB)— 
106 STAT. 240 
PUBLIC LAW 102-300-JUNE 16,1992 
(i) by striking out "aware of information" and insert-
ing in lieu thereof''aware of— 
ns 
, . 
"(i) information"; and 
(ii) by striking out Tadlity, the facility and inserting 
in lieu thereof: nTacility, or 
"(ii) other significant adverse device experiences as deter-
mined l^ the Secretary by regulation to be necessary to be 
reported, 
the facility"; 
and 
^
(
C
) in paragraph (5XBXiii), by striking out 'immediate". 
2iusc360i 
(b) EFFECTIVE DATE.—The amendments made by subsection (a) 
"°*« 
shall take eflFect^ 
(1) 1 year after the date of the enactment of this Act; or 
(2) on the effective date of regulations of the Secretary to 
implement such amendments, 
whichever occurs first. 
SEC. 6. TECHNICALS. 
(a) SECTION 201.—Section 201 (21 U.S.C. 321) is amended— 
(1) in subsection (h), by striking out "any of its principal" 
and inserting in Ueu thereof "its primary"; and 
(2) by addmg at the end the followinjg: 
"(fif) The term 'Commissioner' means the Commissioner of Food 
and Drugs.". 
0>) REFERENCE.— 
(1) Subsections (c) and (d) of sections 201, subsections (a), 
(d), (h), (i), (1), (m), and (o) of section 408, subsections (a) 
and (Jb) of section 536, section 701(b), and subsections (a) and 
(b) of section 801 (21 U.S.C. 321 (c) and (d), 346a (a), (d), 
(h), (i), G), (m), and (o), 360mm (a) and (b), 371(b), and 381 
(a) and (b)) and section 351(c) of the Pi:Jt>lic Healui Service 
Act (42 U.S.C. 262(c)) are each amended by striking out 
"Health, Education, and Welfare" each place it appears and 
inserting in Ueu thereof "Health and Human Services". 
(2) Section 201(y), section 506(a), section 507(a), section 
702(c), section 702A, and section 706(b)(5XCXi) (21 U.S.C. 
321(y), 356(a), 357(a), 372(c), 372a, and 376(bX5XCXi)) are each 
amended by striking out "of Health, Education, and Welfare" 
each place it appears. 
(c) SECTION 304.—Section 304(dXl) (21 U.S.C. 334(dXl)) is 
amended— 
(1) by striking out "801(d)" each place it occurs and inserting 
in Ueu thereof "801(e)"; and 
(2) by striking out "clauses" and inserting in lieu thereof 
"paragraphs". 
(d) SECTION 503.—Section 503(eX3) (21 U.S.C. 353(gX3)) is 
amended by striking out "approval and inserting in Ueu thereof 
"clearance" 
(e) SECTION 513.—Section 513(fX3) (21 U.S.C. 360c(fX3)) is 
amended by redesignating clauses (i), (ii), and (iii) as subparagraphs 
(A), (B), and (C), respectivelv, and by striking out "the 510(k)" 
and inserting in lieu thereof "the section 510(k)". 
(f) SECTION 517.—Section 517(aX10) (21 U.S.C. 360g(aX10)) is 
amended by striking out "520(cX4XB)" and inserting in lieu thereof 
"520(hX4XB)". 
PUBLIC LAW 102-300—JUNE 16,1992 
106 STAT. 241 
(g) SAFE MEDICAL DEVICES ACT OF 1990.—Section 18(b) of the 
Safe Medical Devices Act of 1990 is amended— 
2lUSC360d. 
(1) by striking out '•OoX4XBr and inserting in lieu thereof 
"(br; 
(2) in paragraph (1), by striking out "O)" and inserting in 
lieu thereof'X4r; and 
(3) in paragraph (2), by striking out "(4)* and inserting in 
lieu thereof "(Br. 
Approved June 16,1992. 
LEGISLATIVE HISTORY—S. 2783: 
CONGRESSIONAL RECORD, Vol. 138 (1992): 
May 21, considered and passed Senate. 
May 28, considered and passed House.