IIB 
108TH CONGRESS 
2D SESSION 
H. R. 3493
IN THE SENATE OF THE UNITED STATES 
JANUARY 28, 2004
Received; read twice and referred to the Committee on Health, Education, 
Labor, and Pensions 
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 Modernization 
Act of 2002, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Devices Tech-
nical Corrections Act’’. 
SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC 
LAW 107–250. 
(a) TITLE I; FEES RELATING
TO MEDICAL DE-
VICES.—Part 3 of subchapter C of chapter VII of the Fed-
eral 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 sub-
stantial clinical data are necessary to provide a 
reasonable assurance of safety and effective-
ness’’; 
(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 pre-
market report under section 515 or a pre-
market application under section 351 of the 
Public Health Service Act.’’; and
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(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 ‘‘subsections (d) and (e),’’; 
(II) in clause (iv), by striking 
‘‘clause (i),’’ and all that follows and 
inserting ‘‘clause (i).’’; and 
(III) in clause (vii), by striking 
‘‘clause (i),’’ and all that follows and 
inserting ‘‘clause (i), subject to any 
adjustment 
under 
subsection 
(e)(2)(C)(ii).’’; and 
(ii) in subparagraph (D), in each of 
clauses (i) and (ii), by striking ‘‘applica-
tion’’ and inserting ‘‘application, report,’’;
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(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), begin-
ning in the second sentence, by strik-
ing ‘‘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 subsequent 
fiscal year, where’’; 
(D) in subsection (f), by striking ‘‘for fil-
ing’’; and 
(E) in subsection (h)(2)(B)—
(i) in clause (ii), by redesignating sub-
clauses (I) and (II) as items (aa) and (bb), 
respectively; 
(ii) by redesignating clauses (i) and 
(ii) as subclauses (I) and (II), respectively;
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(iii) by striking ‘‘The Secretary’’ and 
inserting the following: 
‘‘(i) IN
GENERAL.—The Secretary’’; 
and 
(iv) by adding at the end the fol-
lowing: 
‘‘(ii) MORE
THAN
PERCENT.—To 
the extent such costs are more than 5 per-
cent below the specified level in subpara-
graph (A)(ii), fees may not be collected 
under this section for that fiscal year.’’. 
(b) TITLE II; AMENDMENTS REGARDING REGULA-
TION OF MEDICAL DEVICES.—
(1) INSPECTIONS BY ACCREDITED PERSONS.—
Section 704(g) of the Federal Food, Drug, and Cos-
metic 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 inspec-
tions of establishments that manufacture, pre-
pare, propagate, compound, or process class II 
or class III devices, which inspections are re-
quired under section 510(h) or are inspections
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of such establishments required to register 
under section 510(i).’’; 
(B) in paragraph (5)(B), in the first sen-
tence, by inserting after ‘‘standards of accredi-
tation,’’ the following: ‘‘or where the Secretary 
has information indicating that the relationship 
between the establishment and the accredited 
person may create a conflict of interest,’’; 
(C) in paragraph (6)(A)—
(i) in clause (i), by striking ‘‘of the es-
tablishment pursuant to subsection (h) or 
(i) of section 510’’ and inserting ‘‘de-
scribed in paragraph (1)’’; 
(ii) in clause (ii)—
(I) in the matter preceding sub-
clause (I)—
(aa) by striking ‘‘each in-
spection’’ and inserting ‘‘inspec-
tions’’; and 
(bb) by inserting ‘‘during a 
2-year period’’ after ‘‘person’’; 
and 
(II) in subclause (I), by striking 
‘‘such a person’’ and inserting ‘‘an ac-
credited person’’;
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(iii) in clause (iii)—
(I) in the matter preceding sub-
clause (I), by striking ‘‘and the fol-
lowing additional conditions are met:’’ 
and inserting ‘‘and 1 or both of the 
following additional conditions are 
met:’’; 
(II) in subclause (I), by striking 
‘‘identified under subclause (II) of 
this clause’’ and inserting ‘‘identified 
under clause (ii)(II) as a person au-
thorized to conduct inspections of de-
vice establishments’’; and 
(III) in subclause (II), by insert-
ing ‘‘or by a person accredited under 
paragraph (2)’’ after ‘‘by the Sec-
retary’’; 
(iv) in clause (iv)(I)—
(I) in the first sentence—
(aa) by striking ‘‘the two 
immediately 
preceding 
inspec-
tions of the establishment’’ and 
inserting ‘‘inspections of the es-
tablishment during the previous 
4 years’’; and
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(bb) by inserting ‘‘section’’ 
after ‘‘pursuant to’’; 
(II) in the third sentence—
(aa) by striking ‘‘the peti-
tion states a commercial reason 
for the waiver;’’; and 
(bb) by inserting ‘‘not’’ after 
‘‘the Secretary has not deter-
mined that the public health 
would’’; and 
(III) in the fourth sentence, by 
striking ‘‘granted until’’ and inserting 
‘‘granted or deemed to be granted 
until’’; 
(v) in clause (iv)(II)—
(I) by inserting ‘‘of a device es-
tablishment required to register’’ after 
‘‘to be conducted’’; and 
(II) by inserting ‘‘section’’ after 
‘‘pursuant to’’; and 
(vi) by adding at the end the following 
clause: 
‘‘(v) The eligibility of the establishment for in-
spections by accredited persons has not been sus-
pended under subparagraph (B)(iv)(II).’’;
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(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’’; 
(ii) in the second sentence—
(I) by striking ‘‘inspections’’ and 
inserting ‘‘inspectional findings’’; and 
(II) by inserting ‘‘relevant’’ after 
‘‘together with all other’’; and 
(iii)(I) by inserting ‘‘(I)’’ after ‘‘(iii)’’; 
(II) by adding at the end the fol-
lowing subclause: 
‘‘(II) In making a decision under this paragraph, the 
Secretary may consider any information relevant to the 
establishment’s compliance with any provision of this Act. 
Nothing in the preceding sentence shall be construed to 
expand the Secretary’s inspectional authority under sub-
section (a).’’; 
(E) in paragraph (6)(B)(iv)—
(i) by inserting ‘‘(I)’’ after ‘‘(iv)’’; and 
(ii) by adding at the end the following 
subclause: 
‘‘(II) If, during the two-year period following clear-
ance under subparagraph (A) with respect to a device es-
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tablishment, the Secretary obtains information indicating 
significant deviations from compliance with this Act or im-
plementing regulations, the Secretary may, after notice 
and an opportunity for a written response, notify the es-
tablishment that the eligibility of the establishment for in-
spections by accredited person has been suspended.’’; 
(F) in paragraph (6)(C)(ii), by striking ‘‘in 
accordance with section 510(h), or has not dur-
ing such period been inspected pursuant to sec-
tion 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 sub-
section and the number of inspections con-
ducted by Federal employees pursuant to sec-
tion 510(h) and of device establishments re-
quired 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 Sec-
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retary pursuant to inspections conducted 
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 per-
son 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 Federal Food, Drug, and Cos-
metic 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 estab-
lishments’’ after ‘‘in health care facilities’’;
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(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 af-
fords health care facilities the opportunity’’ 
and inserting ‘‘the manufacturer affords 
such users the opportunity’’; and 
(v) by striking ‘‘the health care facil-
ity’’. 
(c) TITLE III; ADDITIONAL AMENDMENTS.—
(1) EFFECTIVE DATE.—Section 301(b) of Pub-
lic Law 107–250 (116 Stat. 1616), is amended by 
striking ‘‘18 months’’ and inserting ‘‘36 months’’. 
(2) 
PREMARKET
NOTIFICATION.—Section 
510(o) of the Federal 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 amend-
ed—
(A) in paragraph (1)(B), by striking ‘‘, 
adulterated’’ and inserting ‘‘or adulterated’’; 
and 
(B) in paragraph (2)—
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(i) in subparagraph (B), by striking ‘‘, 
adulterated’’ and inserting ‘‘or adulter-
ated’’; and 
(ii) in subparagraph (E), by striking 
‘‘semicritical’’ and inserting ‘‘semi-crit-
ical’’. 
(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 para-
graph (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)
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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 AP-
PLICATION,’’ and inserting the following: 
‘‘(2) PREMARKET APPLICATION,’’. 
(B) CONFORMING AMENDMENTS.—Section 
738 of the Federal Food, Drug, and Cosmetic
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Act (21 U.S.C. 379j), as amended by subpara-
graph (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 
(II) in clause (ii), by striking 
‘‘subsection (a)(1)(A)(i)’’ and insert-
ing ‘‘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
AMEND-
MENT.—Section 102(b)(1) of Public Law 107–
250 (116 Stat. 1600) is amended, in the matter 
preceding subparagraph (A), by striking ‘‘sec-
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tion 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 insert-
ing ‘‘(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 
subparagraphs (A) and (B) as paragraphs 
(1) and (2), respectively; and 
(iii) by striking: 
‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB-
MITTING PREMARKET REPORTS.—
‘‘(1) IN GENERAL.—A person submitting a pre-
market report’’ and inserting: 
‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB-
MITTING PREMARKET REPORTS.—A person submitting a 
premarket report’’; and 
(C) in section 212(b)(2) (116 Stat. 1614), 
by striking ‘‘, such as phase IV trials,’’.
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SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DE-
VICES 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 in-
tended for the treatment or diagnosis of diseases and con-
ditions that affect children. The report shall include any 
recommendations of the Secretary of Health and Human 
Services for changes to existing statutory authority, regu-
lations, or agency policy or practice to encourage the in-
vention and development of such devices.
Passed the House of Representatives January 27, 
2004. 
Attest: 
JEFF TRANDAHL, 
Clerk.