Medical Devices Technical Corrections Act
PL 108-214 (S.1881), enacted 04/01/2004

118 STAT. 572
PUBLIC LAW 108–214—APR. 1, 2004
Public Law 108–214
108th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to make technical corrections
relating to the amendments made by the Medical Device User Fee and Moderniza-
tion Act of 2002, 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.
This Act may be cited as the ‘‘Medical Devices Technical Correc-
tions Act’’.
SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107–250.
(a) TITLE I; FEES RELATING
TO MEDICAL DEVICES.—Part 3
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i et seq.), as added by section 102
of Public Law 107–250 (116 Stat. 1589), is amended—
(1) in section 737—
(A) in paragraph (4)(B), by striking ‘‘and for which
clinical data are generally necessary to provide a reasonable
assurance of safety and effectiveness’’ and inserting ‘‘and
for which substantial clinical data are necessary to provide
a reasonable assurance of safety and effectiveness’’;
(B) in paragraph (4)(D), by striking ‘‘manufacturing,’’;
(C) in paragraph (5)(J), by striking ‘‘a premarket
application’’ and all that follows and inserting ‘‘a premarket
application or premarket report under section 515 or a
premarket application under section 351 of the Public
Health Service Act.’’; and
(D) in paragraph (8), by striking ‘‘The term ‘affiliate’
means a business entity that has a relationship with a
second business entity’’ and inserting ‘‘The term ‘affiliate’
means a business entity that has a relationship with a
second business entity (whether domestic or international)’’;
and
(2) in section 738—
(A) in subsection (a)(1)—
(i) in subparagraph (A)—
(I) in the matter preceding clause (i) by
striking ‘‘subsection (d),’’ and inserting ‘‘sub-
sections (d) and (e),’’;
(II) in clause (iv), by striking ‘‘clause (i),’’ and
all that follows and inserting ‘‘clause (i).’’; and
21 USC 379j.
21 USC 379i.
21 USC 301 note.
Medical Devices
Technical
Corrections Act.
Apr. 1, 2004
[S. 1881]
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118 STAT. 573
PUBLIC LAW 108–214—APR. 1, 2004
(III) in clause (vii), by striking ‘‘clause (i),’’
and all that follows and inserting ‘‘clause (i), sub-
ject 
to 
any 
adjustment 
under 
subsection
(e)(2)(C)(ii).’’; and
(ii) in subparagraph (D), in each of clauses (i)
and (ii), by striking ‘‘application’’ and inserting
‘‘application, report,’’;
(B) in subsection (d)(2)(B), beginning in the second
sentence, by striking ‘‘firms. which show’’ and inserting
‘‘firms, which show’’;
(C) in subsection (e)—
(i) in paragraph (1), by striking ‘‘Where’’ and
inserting ‘‘For fiscal year 2004 and each subsequent
fiscal year, where’’; and
(ii) in paragraph (2)—
(I) in subparagraph (B), beginning in the
second sentence, by striking ‘‘firms. which show’’
and inserting ‘‘firms, which show’’; and
(II) in subparagraph (C)(i), by striking ‘‘Where’’
and inserting ‘‘For fiscal year 2004 and each subse-
quent fiscal year, where’’;
(D) in subsection (f), by striking ‘‘for filing’’; and
(E) in subsection (h)(2)(B)—
(i) in clause (ii), by redesignating subclauses (I)
and (II) as items (aa) and (bb), respectively;
(ii) by redesignating clauses (i) and (ii) as sub-
clauses (I) and (II), respectively;
(iii) by striking ‘‘The Secretary’’ and inserting the
following:
‘‘(i) IN GENERAL.—The Secretary’’; and
(iv) by adding at the end the following:
‘‘(ii) MORE THAN 5 PERCENT.—To the extent such
costs are more than 5 percent below the specified level
in subparagraph (A)(ii), fees may not be collected under
this section for that fiscal year.’’.
(b) TITLE II; AMENDMENTS REGARDING REGULATION OF MEDICAL
DEVICES.—
(1) INSPECTIONS BY ACCREDITED PERSONS.—Section 704(g)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)),
as added by section 201 of Public Law 107–250 (116 Stat.
1602), is amended—
(A) in paragraph (1), in the first sentence, by striking
‘‘conducting inspections’’ and all that follows and inserting
‘‘conducting inspections of establishments that manufac-
ture, prepare, propagate, compound, or process class II
or class III devices, which inspections are required under
section 510(h) or are inspections of such establishments
required to register under section 510(i).’’;
(B) in paragraph (5)(B), in the first sentence, by
striking ‘‘or poses’’ and all that follows through the period
and inserting ‘‘poses a threat to public health, fails to
act in a manner that is consistent with the purposes of
this subsection, or where the Secretary determines that
there is a financial conflict of interest in the relationship
between the accredited person and the owner or operator
of a device establishment that the accredited person has
inspected under this subsection.’’;
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118 STAT. 574
PUBLIC LAW 108–214—APR. 1, 2004
(C) in paragraph (6)(A)—
(i) in clause (i), by striking ‘‘of the establishment
pursuant to subsection (h) or (i) of section 510’’ and
inserting ‘‘described in paragraph (1)’’;
(ii) in clause (ii)—
(I) in the matter preceding subclause (I)—
(aa) by striking ‘‘each inspection’’ and
inserting ‘‘inspections’’; and
(bb) by inserting ‘‘during a 2-year period’’
after ‘‘person’’; and
(II) in subclause (I), by striking ‘‘such a per-
son’’ and inserting ‘‘an accredited person’’;
(iii) in clause (iii)—
(I) in the matter preceding subclause (I), by
striking ‘‘and the following additional conditions
are met:’’ and inserting ‘‘and 1 or both of the
following additional conditions are met:’’;
(II) in subclause (I), by striking ‘‘accredited’’
and all that follows through the period and
inserting ‘‘(accredited under paragraph (2) and
identified under clause (ii)(II)) as a person author-
ized to conduct such inspections of device establish-
ments.’’; and
(III) in subclause (II), by inserting ‘‘or by a
person accredited under paragraph (2)’’ after ‘‘by
the Secretary’’;
(iv) in clause (iv)(I)—
(I) in the first sentence—
(aa) by striking ‘‘the two immediately pre-
ceding inspections of the establishment’’ and
inserting ‘‘inspections of the establishment
during the previous 4 years’’; and
(bb) by inserting ‘‘section’’ after ‘‘pursuant
to’’;
(II) in the third sentence—
(aa) by striking ‘‘the petition states a
commercial reason for the waiver;’’; and
(bb) by inserting ‘‘not’’ after ‘‘the Secretary
has not determined that the public health
would’’; and
(III) in the fourth sentence, by striking
‘‘granted until’’ and inserting ‘‘granted or deemed
to be granted until’’; and
(v) in clause (iv)(II)—
(I) by inserting ‘‘of a device establishment
required to register’’ after ‘‘to be conducted’’; and
(II) by inserting ‘‘section’’ after ‘‘pursuant to’’;
(D) in paragraph (6)(B)(iii)—
(i) in the first sentence, by striking ‘‘, and data
otherwise describing whether the establishment has
consistently been in compliance with sections 501 and
502 and other’’ and inserting ‘‘and with other’’; and
(ii) in the second sentence—
(I) by striking ‘‘inspections’’ and inserting
‘‘inspectional findings’’; and
(II) by inserting ‘‘relevant’’ after ‘‘together with
all other’’;
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PUBLIC LAW 108–214—APR. 1, 2004
(E) in paragraph (6)(B)(iv)—
(i) by inserting ‘‘(I)’’ after ‘‘(iv)’’; and
(ii) by adding at the end the following:
‘‘(II) If, during the two-year period following clearance under
subparagraph (A), the Secretary determines that the device
establishment is substantially not in compliance with this Act,
the Secretary may, after notice and a written response, notify
the establishment that the eligibility of the establishment for the
inspections by accredited persons has been suspended.’’;
(F) in paragraph (6)(C)(ii), by striking ‘‘in accordance
with section 510(h), or has not during such period been
inspected pursuant to section 510(i), as applicable’’;
(G) in paragraph (10)(B)(iii), by striking ‘‘a reporting’’
and inserting ‘‘a report’’; and
(H) in paragraph (12)—
(i) by striking subparagraph (A) and inserting the
following:
‘‘(A) the number of inspections conducted by accredited
persons pursuant to this subsection and the number of inspec-
tions conducted by Federal employees pursuant to section
510(h) and of device establishments required to register under
section 510(i);’’; and
(ii) in subparagraph (E), by striking ‘‘obtained by
the Secretary’’ and all that follows and inserting
‘‘obtained by the Secretary pursuant to inspections con-
ducted by Federal employees;’’.
(2) OTHER CORRECTIONS.—
(A) PROHIBITED ACTS.—Section 301(gg) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as
amended by section 201(d) of Public Law 107–250 (116
Stat. 1609), is amended to read as follows:
‘‘(gg) The knowing failure to comply with paragraph (7)(E)
of section 704(g); the knowing inclusion by a person accredited
under paragraph (2) of such section of false information in an
inspection report under paragraph (7)(A) of such section; or the
knowing failure of such a person to include material facts in such
a report.’’.
(B) ELECTRONIC LABELING.—Section 502(f) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)), as
amended by section 206 of Public Law 107–250 (116 Stat.
1613), is amended, in the last sentence—
(i) by inserting ‘‘or by a health care professional
and required labeling for in vitro diagnostic devices
intended for use by health care professionals or in
blood establishments’’ after ‘‘in health care facilities’’;
(ii) by inserting a comma after ‘‘means’’;
(iii) by striking ‘‘requirements of law and, that’’
and inserting ‘‘requirements of law, and that’’;
(iv) by striking ‘‘the manufacturer affords health
care facilities the opportunity’’ and inserting ‘‘the
manufacturer affords such users the opportunity’’; and
(v) by striking ‘‘the health care facility’’.
(c) TITLE III; ADDITIONAL AMENDMENTS.—
(1) EFFECTIVE DATE.—Section 301(b) of Public Law 107–
250 (116 Stat. 1616), is amended by striking ‘‘18 months’’
and inserting ‘‘36 months’’.
21 USC 352 note.
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118 STAT. 576
PUBLIC LAW 108–214—APR. 1, 2004
(2) PREMARKET NOTIFICATION.—Section 510(o) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added
by section 302(b) of Public Law 107–250 (116 Stat. 1616),
is amended—
(A) in paragraph (1)(B), by striking ‘‘, adulterated’’
and inserting ‘‘or adulterated’’; and
(B) in paragraph (2)—
(i) in subparagraph (B), by striking ‘‘, adulterated’’
and inserting ‘‘or adulterated’’; and
(ii) in subparagraph (E), by striking ‘‘semicritical’’
and inserting ‘‘semi-critical’’.
(d) MISCELLANEOUS CORRECTIONS.—
(1) CERTAIN AMENDMENTS TO SECTION 515.—
(A) IN GENERAL.—
(i) TECHNICAL CORRECTION.—Section 515(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360e(c)), as amended by sections 209 and 302(c)(2)(A)
of Public Law 107–250 (116 Stat. 1613, 1618), is
amended by redesignating paragraph (3) (as added
by section 209 of such Public Law) as paragraph (4).
(ii) MODULAR REVIEW.—Section 515(c)(4)(B) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360e(c)(4)(B)) is amended by striking ‘‘unless an issue
of safety’’ and inserting ‘‘unless a significant issue of
safety’’.
(B) CONFORMING AMENDMENT.—Section 210 of Public
Law 107–250 (116 Stat. 1614) is amended by striking
‘‘, as amended’’ and all that follows through ‘‘by adding’’
and inserting ‘‘is amended in paragraph (3), as redesignated
by section 302(c)(2)(A) of this Act, by adding’’.
(2) CERTAIN AMENDMENTS TO SECTION 738.—
(A) IN GENERAL.—Section 738(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j(a)), as amended
by subsection (a), is amended—
(i) in the matter preceding paragraph (1)—
(I) by striking ‘‘(a) TYPES OF FEES.—Beginning
on’’ and inserting the following:
‘‘(a) TYPES OF FEES.—
‘‘(1) IN GENERAL.—Beginning on’’; and
(II) by striking ‘‘this section as follows:’’ and
inserting ‘‘this section.’’; and
(ii) by striking ‘‘(1) PREMARKET APPLICATION,’’ and
inserting the following: ‘‘(2) PREMARKET APPLICATION,’’.
(B) CONFORMING
AMENDMENTS.—Section 738 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j),
as amended by subparagraph (A), is amended—
(i) in subsection (d)(1), in the last sentence, by
striking ‘‘subsection (a)(1)(A)’’ and inserting ‘‘subsection
(a)(2)(A)’’;
(ii) in subsection (e)(1), by striking ‘‘subsection
(a)(1)(A)(vii)’’ and inserting ‘‘subsection (a)(2)(A)(vii)’’;
(iii) in subsection (e)(2)(C)—
(I) in each of clauses (i) and (ii), by striking
‘‘subsection (a)(1)(A)(vii)’’ and inserting ‘‘subsection
(a)(2)(A)(vii)’’; and
21 USC 360e.
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118 STAT. 577
PUBLIC LAW 108–214—APR. 1, 2004
(II) in clause (ii), by striking ‘‘subsection
(a)(1)(A)(i)’’ and inserting ‘‘subsection (a)(2)(A)(i)’’;
and
(iv) in subsection (j), by striking ‘‘subsection
(a)(1)(D),’’ and inserting ‘‘subsection (a)(2)(D),’’.
(C) ADDITIONAL
CONFORMING
AMENDMENT.—Section
102(b)(1) of Public Law 107–250 (116 Stat. 1600) is
amended, in the matter preceding subparagraph (A), by
striking ‘‘section 738(a)(1)(A)(ii)’’ and inserting ‘‘section
738(a)(2)(A)(ii)’’.
(3) PUBLIC LAW 107–250.—Public Law 107–250 is amended—
(A) in section 102(a) (116 Stat. 1589), by striking ‘‘(21
U.S.C. 379F et seq.)’’ and inserting ‘‘(21 U.S.C. 379f et
seq.)’’;
(B) in section 102(b) (116 Stat. 1600)—
(i) by striking paragraph (2);
(ii) in paragraph (1), by redesignating subpara-
graphs (A) and (B) as paragraphs (1) and (2), respec-
tively; and
(iii) by striking:
‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PRE-
MARKET REPORTS.—
‘‘(1) IN GENERAL.—A person submitting a premarket report’’
and inserting:
‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PRE-
MARKET REPORTS.—A person submitting a premarket report’’; and
(C) in section 212(b)(2) (116 Stat. 1614), by striking
‘‘, such as phase IV trials,’’.
SEC. 3. REPORT 
ON 
BARRIERS 
TO 
AVAILABILITY 
OF 
DEVICES
INTENDED FOR CHILDREN.
Not later than 180 days after the date of enactment of this
Act, the Secretary of Health and Human Services shall submit
to the Committee on Health, Education, Labor, and Pensions of
the Senate and the Committee on Energy and Commerce of the
House of Representatives a report on the barriers to the availability
of devices intended for the treatment or diagnosis of diseases and
conditions that affect children. The report shall include any rec-
ommendations of the Secretary of Health and Human Services
for changes to existing statutory authority, regulations, or agency
Deadline.
21 USC 360l
note.
21 USC 379i,
379j.
21 USC 379j
note.
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118 STAT. 578
PUBLIC LAW 108–214—APR. 1, 2004
LEGISLATIVE HISTORY—S. 1881 (H.R. 3493):
HOUSE REPORTS: No. 108–433 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD:
Vol. 149 (2003): Nov. 25, considered and passed Senate.
Vol. 150 (2004): Mar. 9, 10, considered and passed House, amended.
Mar. 12, Senate concurred in House amendment.
policy or practice to encourage the invention and development of
such devices.
Approved April 1, 2004.
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