I 
108TH CONGRESS 
1ST SESSION H. R. 3493
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. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 17, 2003
Mr. GREENWOOD (for himself and Ms. ESHOO) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
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, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Devices Tech-
nical Corrections Act of 2003’’.
SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC 
LAW 107–250. 
(a) TITLE I; FEES RELATING
TO MEDICAL DE-
VICES.—
(1) TYPES OF FEES.—Section 738 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
379j), as added by section 102 of Public Law 107–
250 (116 Stat. 1589), is amended by amending sub-
section (a) to read as follows: 
‘‘(a) TYPES OF FEES.—Beginning on the date of the 
enactment of the Medical Device User Fee and Moderniza-
tion Act of 2002, the Secretary shall assess and collect 
fees in accordance with this section as follows: 
‘‘(1) PREMARKET
APPLICATION, PREMARKET 
REPORT, SUPPLEMENT, AND SUBMISSION FEE.—Ex-
cept as provided in paragraph (2) and subsections 
(d) and (e), each person who submits any of the fol-
lowing, on or after October 1, 2002, shall be subject 
to a fee established under subsection (c)(5) for the 
fiscal year involved in accordance with the following: 
‘‘(A) A premarket application. 
‘‘(B) For a premarket report, a fee equal 
to the fee that applies under subparagraph (A). 
‘‘(C) For a panel track supplement, a fee 
equal to the fee that applies under subpara-
graph (A).
‘‘(D) For a 180-day supplement, a fee 
equal to 21.5 percent of the fee that applies 
under subparagraph (A). 
‘‘(E) For a real-time supplement, a fee 
equal to 7.2 percent of the fee that applies 
under subparagraph (A). 
‘‘(F) For an efficacy supplement, a fee 
equal to the fee that applies under subpara-
graph (A). 
‘‘(G) For a premarket notification submis-
sion, a fee equal to 1.42 percent of the fee that 
applies under subparagraph (A), subject to any 
adjustment under subsection (e)(2)(C)(ii). 
‘‘(2) EXCEPTIONS.—
‘‘(A) 
HUMANITARIAN
DEVICE
EXEMP-
TION.—An application under section 520(m) is 
not subject to any fee under paragraph (1). 
‘‘(B) FURTHER
MANUFACTURING
USE.—
No fee shall be required under paragraph (1) 
for the submission of a premarket application 
under section 351 of the Public Health Service 
Act for a product licensed for further manufac-
turing use only. 
‘‘(C) STATE
OR
FEDERAL
GOVERNMENT 
SPONSORS.—No fee shall be required under
paragraph (1) for a premarket application, pre-
market report, supplement, or premarket notifi-
cation submission submitted by a State or Fed-
eral Government entity unless the device in-
volved is to be distributed commercially. 
‘‘(D) 
PREMARKET
NOTIFICATIONS
BY 
THIRD
PARTIES.—No fee shall be required 
under paragraph (1) for a premarket notifica-
tion submission reviewed by an accredited per-
son pursuant to section 523. 
‘‘(E) PEDIATRIC CONDITIONS OF USE.—
‘‘(i) IN GENERAL.—No fee shall be re-
quired under paragraph (1) for a pre-
market application, premarket report, or 
premarket notification submission if the 
proposed conditions of use for the device 
involved are solely for a pediatric popu-
lation. No fee shall be required under such 
subparagraph for a supplement if the sole 
purpose of the supplement is to propose 
conditions of use for a pediatric popu-
lation. 
‘‘(ii) 
SUBSEQUENT
PROPOSAL
OF 
ADULT CONDITIONS OF USE.—In the case 
of a person who submits a premarket ap-
plication or premarket report for which, 
under clause (i), a fee under paragraph (1) 
is not required, any supplement to such 
application that proposes conditions of use 
for any adult population is subject to the 
fee that applies under such subparagraph 
for a premarket application. 
‘‘(3) PAYMENT.—The fee required by para-
graph (1) shall be due upon submission of the pre-
market application, premarket report, supplement, 
or premarket notification submission, except that in-
voices for applications submitted on or after October 
1, 2002, and before the date on which appropria-
tions under subsection (h)(3) for fiscal year 2003 
first become available shall be payable within 30 
days of the issuance of such invoices. Applicants 
submitting portions of applications pursuant to sec-
tion 515(c)(3) shall pay such fees upon submission 
of the first portion of such applications. The fees 
credited to fiscal year 2003 under this section shall
include all fees payable from October 1, 2002, 
through September 30, 2003. 
‘‘(4) REFUNDS.—
‘‘(A) APPLICATION
REFUSED
FOR
FIL-
ING.—The Secretary shall refund 75 percent of
the fee paid under paragraph (1) for any appli-
cation, report, or supplement that is refused for 
filing. 
‘‘(B) APPLICATION
WITHDRAWN
BEFORE 
FILING.—The Secretary shall refund 75 percent 
of the fee paid under paragraph (1) for any ap-
plication, report, or supplement that is with-
drawn prior to the filing decision of the Sec-
retary. 
‘‘(C) APPLICATION
WITHDRAWN
BEFORE 
FIRST ACTION.—After receipt of a request for a 
refund of the fee paid under paragraph (1) for 
a premarket application, premarket report, or 
supplement that is withdrawn after filing but 
before a first action, the Secretary may return 
some or all of the fee. The amount of refund, 
if any, shall be based on the level of effort al-
ready expended on the review of such applica-
tion, report, or supplement. The Secretary shall 
have sole discretion to refund a fee or portion 
of the fee under this subparagraph. A deter-
mination by the Secretary concerning a refund 
under this paragraph shall not be reviewable.’’. 
(2) 
OTHER
CORRECTIONS
RELATING
TO 
FEES.—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—
(A) in section 737—
(i) in paragraph (4)—
(I) in subparagraph (B), by 
striking ‘‘and for which’’ and all that 
follows and inserting the following: 
‘‘and for which substantial clinical 
data are necessary to provide a rea-
sonable assurance of safety and effec-
tiveness.’’; and 
(II) in subparagraph (D), by 
striking ‘‘manufacturing,’’; 
(ii) in paragraph (5)(J), by striking 
‘‘a premarket application’’ and all that fol-
lows and inserting the following: ‘‘a pre-
market application or premarket report 
under section 515 or a premarket applica-
tion under section 351 of the Public 
Health Service Act.’’; and 
(iii) in paragraph (8), in the matter 
preceding subparagraph (A), by inserting 
‘‘(whether domestic or international)’’ after 
‘‘second business entity’’; and
(B) in section 738—
(i) in subsection (d)(2)(B), beginning 
in the second sentence, by striking ‘‘firms. 
which show’’ and inserting ‘‘firms, which 
show’’; 
(ii) 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)—
(aa) in subparagraph (B), 
beginning in the second sentence, 
by striking ‘‘firms. which show’’ 
and 
inserting 
‘‘firms, 
which 
show’’; and 
(bb) in subparagraph (C)(i), 
by striking ‘‘Where’’ and insert-
ing ‘‘For fiscal year 2004 and 
each 
subsequent 
fiscal 
year, 
where’’; 
(iii) in subsection (f), by striking ‘‘for 
filing’’ and inserting ‘‘for review’’; and 
(iv) in subsection (h)(2)—
(I) in subparagraph (A), by strik-
ing clause (ii) and inserting the fol-
lowing: 
‘‘(ii) shall only be collected and avail-
able to defray increases in the costs of the 
resources allocated for the purposes for the 
review of device applications (including in-
creases in such costs for an additional 
number of full-time equivalent positions in 
the Department of Health and Human 
Services to be engaged in such process) 
over such costs for fiscal year 2002 when 
multiplied by the adjustment factor. 
For purposes of this subparagraph, the deter-
mination of the costs of the resources allocated 
for the process for the review of device applica-
tions for fiscal year 2003 through 2007 shall 
not include costs paid from fees collected under 
this section.’’; and 
(II) in subparagraph (B), by in-
serting after and below clause (ii)((II) 
the following: 
‘‘To the extent such costs are more than 5 per-
cent below the level specified in subparagraph
(A)(ii), fees may not be collected under this sec-
tion 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 the following: ‘‘con-
ducting inspections of establishments that man-
ufacture, prepare, propagate, compound, or 
process class II or class III devices, which in-
spections are required in section 510(h) or are 
inspections of such establishments required to 
register under section 510(i).’’; 
(B) in paragraph (6)(A)—
(i) in the matter preceding clause (i), 
by inserting ‘‘during a two-year period’’ 
after ‘‘paragraph (2)’’; 
(ii) in clause (i), by striking ‘‘most re-
cent inspection’’ and all that follows 
through ‘‘section 510 as’’ and inserting
‘‘most recent inspection described in para-
graph (1) as’’; 
(iii) in clause (ii)—
(I) in the matter preceding sub-
clause (I), by striking ‘‘With respect 
to’’ and all that follows and inserting 
the following: ‘‘With respect to the in-
spections to be conducted by an ac-
credited person during such two-year 
period—’’; 
(II) in subclause (I), by striking 
‘‘such a person to conduct the inspec-
tion,’’ and inserting ‘‘an accredited 
person to conduct the inspections,’’; 
and 
(III) in subclause (II), by strik-
ing ‘‘the inspection,’’ and inserting 
‘‘the inspections,’’; 
(iv) in clause (iii)—
(I) in the matter preceding sub-
clause 
(I), 
by 
striking 
‘‘United 
States,’’ and all that follows and in-
serting ‘‘United States, and—’’; 
(II) in subclause (I)—
(aa) by striking ‘‘At least 
one’’ and inserting ‘‘at least 
one’’; and 
(bb) by striking ‘‘identified 
under subclause (II) of this 
clause.’’ and inserting ‘‘identified 
under clause (ii)(II); or’’; and 
(III) in subclause (II), by strik-
ing ‘‘The owner’’ and inserting ‘‘the 
owner’’; and 
(v) in clause (iv)—
(I) in subclause (I), in the first 
sentence, by striking ‘‘In the case of’’ 
and all that follows through ‘‘except 
that’’ and inserting the following: ‘‘In 
the case of inspections to be con-
ducted pursuant to section 510(h), 
persons accredited under paragraph 
(2) did not conduct any inspection of 
the establishment during the two pre-
ceding two-year periods referred to in 
such section with respect to the estab-
lishment, except that’’; 
(II) in subclause (II), by striking ‘‘In 
the case of’’ and all that follows through
‘‘the Secretary’’ and inserting the fol-
lowing: ‘‘In the case of inspections to be 
conducted of a device establishment re-
quired to register under section 510(i), the 
Secretary’’; 
(C) in paragraph (6)(B)—
(i) in clause (iii)—
(I) by striking ‘‘and data other-
wise’’ in the first sentence and all that 
follows through ‘‘reports of inspec-
tions regarding’’ in the second sen-
tence and inserting the following: 
‘‘and data describing compliance with 
other applicable provisions of this Act. 
Such data shall include reports of 
inspectional findings regarding’’; and 
(II) in the second sentence, by 
striking 
‘‘establishment, 
together 
with’’ and all that follows and insert-
ing ‘‘establishment.’’; and 
(ii) in clause (v), by adding at the end 
the following subclause: 
‘‘(III) The agreement (or deemed agreement) of 
the Secretary under this subparagraph to the selec-
tion of an accredited person is effective for the two-
year period referred to in the matter preceding 
clause (i) of subparagraph (A), subject to paragraph 
(5)(B).’’; 
(D) in paragraph (6)(C)(ii), in the last 
sentence, by inserting before the period the fol-
lowing: ‘‘and may submit a notice under sub-
paragraph (A)’’; 
(E) in paragraph (10)(B)(iii), by striking 
‘‘a reporting’’ and inserting ‘‘a report’’; and 
(F) in paragraph (12)—
(i) in subparagraph (A), by striking 
‘‘the number of’’ the first place such term 
appears and all that follows and inserting 
the following: ‘‘the number of inspections 
conducted by accredited persons pursuant 
to this subsection and the number of in-
spections 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 Sec-
retary pursuant to inspections conducted 
by Federal employees;’’.
(2) OTHER CORRECTIONS.—Chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.), as amended by sections 204 and 206 
of Public Law 107–250 (116 Stat. 1611, 1613), is 
amended—
(A) in section 502(f), in the last sen-
tence—
(i) by striking ‘‘requirements of law 
and, that’’ and inserting ‘‘requirements of 
law, that’’; and 
(ii) by striking ‘‘and after such re-
quest, promptly provides’’ and inserting 
‘‘and that, after receiving such request, the 
manufacturer promptly provides’’; and 
(B) in section 503(g)(4)(A), in the second 
sentence, by striking ‘‘shall, in determining 
whether’’ and all that follows through ‘‘consult’’ 
and inserting the following: ‘‘shall, in deter-
mining whether the product to be assigned is
appropriately classified as a combination prod-
uct, consult’’. 
(c) TITLE III; ADDITIONAL AMENDMENTS.—
(1) IN
GENERAL.—The Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 301 et seq.), as
amended by sections 301 and 302 of Public Law 
107–250 (116 Stat. 1616), is amended—
(A) in section 502 (21 U.S.C. 352)—
(i) by striking paragraph (u); and 
(ii) by redesignating paragraph (v) as 
paragraph (u); and 
(B) in section 510(o) (21 U.S.C. 360(o))—
(i) in paragraph (1)(B), in the third 
sentence, by striking ‘‘misbranded under 
section 502(o), adulterated under’’ and in-
serting ‘‘misbranded under section 502(o) 
or adulterated under’’; and 
(ii) in paragraph (2)—
(I) in subparagraph (B), in the 
third sentence, by striking ‘‘mis-
branded under section 502(o), adul-
terated under’’ and inserting ‘‘mis-
branded under section 502(o) or adul-
terated under’’; and 
(II) in subparagraph (E), by 
striking ‘‘semicritical’’ and inserting 
‘‘semi-critical’’. 
(2) CONFORMING
AMENDMENT.—Section 301 
of Public Law 107–250 (116 Stat. 1616) is amend-
ed by striking subsection (b).
(d) MISCELLANEOUS CORRECTIONS.—
(1) CERTAIN
AMENDMENTS
REGARDING
SEC-
TION 515(c).—
(A) IN GENERAL.—Section 515(c) of the 
Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e), as amended by sections 209 and 
302(c)(2)(A) of Public Law 107–250 (116 Stat. 
1613, 1618), is amended—
(i) by redesignating the second para-
graph (3) (added by section 209 of such 
Public Law) as paragraph (4); and 
(ii) in paragraph (4) (as so redesig-
nated), in subparagraph (B), by striking 
‘‘an issue’’ and inserting ‘‘a new issue’’. 
(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 
the following: ‘‘is amended in paragraph (3), as 
redesignated by section 302(c)(2)(A) of this 
Act, by adding’’. 
(2) CONFORMING
AMENDMENTS
REGARDING 
REFERENCES TO SECTION 738(a).—
(A) IN GENERAL.—Section 738 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
379j), as amended by subparagraph (A) of this 
paragraph, is amended—
(i) in subsection (d)(1), in the last 
sentence, by striking ‘‘clauses (i) through 
(vi) of subsection (a)(1)(A)’’ and inserting 
‘‘subparagraphs (A) through (F) of sub-
section (a)(1)’’; 
(ii) in subsection (e)(1), by striking 
‘‘subsection (a)(1)(A)(vii)’’ and inserting 
‘‘subsection (a)(1)(G)’’; 
(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)(1)(G)’’; 
and 
(II) in clause (ii), by striking 
‘‘subsection (a)(1)(A)(i)’’ and insert-
ing ‘‘subsection (a)(1)(A)’’; and 
(iv) in subsection (j), by striking 
‘‘subsection 
(a)(1)(D),’’ 
and 
inserting 
‘‘subsection (a)(4),’’. 
(B) 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-
tion 738(a)(1)(A)(ii)’’ and inserting ‘‘section 
738(a)(1)(B)’’. 
(3) PUBLIC
LAW
107–250.—Public Law 107–
250 is amended—
(A) in section 102—
(i) in subsection (a) (116 Stat. 1589), 
by striking ‘‘(21 U.S.C. 379F et seq.)’’ 
and inserting ‘‘(21 U.S.C. 379f et seq.)’’; 
and 
(ii) in subsection (b) (116 Stat. 
1600), by striking paragraph (2); 
(B) in section 212(b)(2) (116 Stat. 1614), 
by striking ‘‘medical devices, such as phase IV 
trials, and’’ and inserting ‘‘medical devices 
and’’; and 
(C) in section 214(a)(3) (116 Stat. 1615), 
by striking ‘‘discussion’’ and inserting ‘‘presen-
tation’’. 
(4) PUBLIC
HEALTH
SERVICE
ACT.—Section 
498C of the Public Health Service Act (42 U.S.C. 
289g–3), as added by section 215(b) of Public Law 
107–250 (116 Stat. 1615), is amended in subsection 
(a) by striking ‘‘Director of NIH may’’ and inserting 
‘‘Director of NIH shall’’.
(e) HUMANITARIAN DEVICE EXEMPTION; PEDIATRIC 
PATIENTS.—Section 520(m)(3) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(m)(3)) is amend-
ed—
(1) by striking ‘‘(3) No person’’ and inserting 
‘‘(3)(A) Except as provided in subparagraph (B), no 
person’’; and 
(2) by adding at the end the following: 
‘‘(B)(i) Subparagraph (A) does not apply with re-
spect to any device intended for the treatment or diagnosis 
of a pediatric condition. 
‘‘(ii) For purposes of this subsection: 
‘‘(I) The term ‘pediatric condition’ means a dis-
ease, disorder, or other condition unique to, more se-
rious, or more prevalent in pediatric patients. 
‘‘(II) The term ‘pediatric patient’ means a pa-
tient who is under 15 years of age at the time of 
diagnosis or treatment.’’.
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