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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Devices Tech5 nical Corrections Act of 2003’’. 
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1 SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC 

2 LAW 107–250. 

3 (a) TITLE I; FEES RELATING TO MEDICAL DE4 VICES.—

5 (1) TYPES OF FEES.—Section 738 of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

7 379j), as added by section 102 of Public Law 107–

8 250 (116 Stat. 1589), is amended by amending sub9 section (a) to read as follows: 

10 ‘‘(a) TYPES OF FEES.—Beginning on the date of the 

11 enactment of the Medical Device User Fee and Moderniza12 tion Act of 2002, the Secretary shall assess and collect 

13 fees in accordance with this section as follows: 

14 ‘‘(1) PREMARKET APPLICATION, PREMARKET

15 REPORT, SUPPLEMENT, AND SUBMISSION FEE.—Ex16 cept as provided in paragraph (2) and subsections 

17 (d) and (e), each person who submits any of the fol18 lowing, on or after October 1, 2002, shall be subject 

19 to a fee established under subsection (c)(5) for the 

20 fiscal year involved in accordance with the following: 

21 ‘‘(A) A premarket application. 

22 ‘‘(B) For a premarket report, a fee equal 

23 to the fee that applies under subparagraph (A). 

24 ‘‘(C) For a panel track supplement, a fee 

25 equal to the fee that applies under subpara26 graph (A). 
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1 ‘‘(D) For a 180-day supplement, a fee 

2 equal to 21.5 percent of the fee that applies 

3 under subparagraph (A). 

4 ‘‘(E) For a real-time supplement, a fee 

5 equal to 7.2 percent of the fee that applies 

6 under subparagraph (A). 

7 ‘‘(F) For an efficacy supplement, a fee 

8 equal to the fee that applies under subpara9 graph (A). 

10 ‘‘(G) For a premarket notification submis11 sion, a fee equal to 1.42 percent of the fee that 

12 applies under subparagraph (A), subject to any 

13 adjustment under subsection (e)(2)(C)(ii). 

14 ‘‘(2) EXCEPTIONS.—

15 ‘‘(A) HUMANITARIAN DEVICE EXEMP16 TION.—An application under section 520(m) is 

17 not subject to any fee under paragraph (1). 

18 ‘‘(B) FURTHER MANUFACTURING USE.—

19 No fee shall be required under paragraph (1) 

20 for the submission of a premarket application 

21 under section 351 of the Public Health Service 

22 Act for a product licensed for further manufac23 turing use only. 

24 ‘‘(C) STATE OR FEDERAL GOVERNMENT

25 SPONSORS.—No fee shall be required under 
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1 paragraph (1) for a premarket application, pre2 market report, supplement, or premarket notifi3 cation submission submitted by a State or Fed4 eral Government entity unless the device in5 volved is to be distributed commercially. 

6 ‘‘(D) PREMARKET NOTIFICATIONS BY

7 THIRD PARTIES.—No fee shall be required 

8 under paragraph (1) for a premarket notifica9 tion submission reviewed by an accredited per10 son pursuant to section 523. 

11 ‘‘(E) PEDIATRIC CONDITIONS OF USE.—

12 ‘‘(i) IN GENERAL.—No fee shall be re13 quired under paragraph (1) for a pre14 market application, premarket report, or 

15 premarket notification submission if the 

16 proposed conditions of use for the device 

17 involved are solely for a pediatric popu18 lation. No fee shall be required under such 

19 subparagraph for a supplement if the sole 

20 purpose of the supplement is to propose 

21 conditions of use for a pediatric popu22 lation. 

23 ‘‘(ii) SUBSEQUENT PROPOSAL OF

24 ADULT CONDITIONS OF USE.—In the case 

25 of a person who submits a premarket ap-
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1 plication or premarket report for which, 

2 under clause (i), a fee under paragraph (1) 

3 is not required, any supplement to such 

4 application that proposes conditions of use 

5 for any adult population is subject to the 

6 fee that applies under such subparagraph 

7 for a premarket application. 

8 ‘‘(3) PAYMENT.—The fee required by para9 graph (1) shall be due upon submission of the pre10 market application, premarket report, supplement, 

11 or premarket notification submission, except that in12 voices for applications submitted on or after October 

13 1, 2002, and before the date on which appropria14 tions under subsection (h)(3) for fiscal year 2003 

15 first become available shall be payable within 30 

16 days of the issuance of such invoices. Applicants 

17 submitting portions of applications pursuant to sec18 tion 515(c)(3) shall pay such fees upon submission 

19 of the first portion of such applications. The fees 

20 credited to fiscal year 2003 under this section shall

21 include all fees payable from October 1, 2002, 

22 through September 30, 2003. 

23 ‘‘(4) REFUNDS.—

24 ‘‘(A) APPLICATION REFUSED FOR FIL25 ING.—The Secretary shall refund 75 percent of 
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1 the fee paid under paragraph (1) for any appli2 cation, report, or supplement that is refused for 

3 filing. 

4 ‘‘(B) APPLICATION WITHDRAWN BEFORE

5 FILING.—The Secretary shall refund 75 percent 

6 of the fee paid under paragraph (1) for any ap7 plication, report, or supplement that is with8 drawn prior to the filing decision of the Sec9 retary. 

10 ‘‘(C) APPLICATION WITHDRAWN BEFORE

11 FIRST ACTION.—After receipt of a request for a 

12 refund of the fee paid under paragraph (1) for 

13 a premarket application, premarket report, or 

14 supplement that is withdrawn after filing but 

15 before a first action, the Secretary may return 

16 some or all of the fee. The amount of refund, 

17 if any, shall be based on the level of effort al18 ready expended on the review of such applica19 tion, report, or supplement. The Secretary shall 

20 have sole discretion to refund a fee or portion 

21 of the fee under this subparagraph. A deter22 mination by the Secretary concerning a refund 

23 under this paragraph shall not be reviewable.’’. 

24 (2) OTHER CORRECTIONS RELATING TO

25 FEES.—Part 3 of subchapter C of chapter VII of the 
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1 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 379i et seq.), as added by section 102 of Public Law 

3 107–250 (116 Stat. 1589), is amended—

4 (A) in section 737—

5 (i) in paragraph (4)—

6 (I) in subparagraph (B), by 

7 striking ‘‘and for which’’ and all that 

8 follows and inserting the following: 

9 ‘‘and for which substantial clinical 

10 data are necessary to provide a rea11 sonable assurance of safety and effec12 tiveness.’’; and 

13 (II) in subparagraph (D), by 

14 striking ‘‘manufacturing,’’; 

15 (ii) in paragraph (5)(J), by striking 

16 ‘‘a premarket application’’ and all that fol17 lows and inserting the following: ‘‘a pre18 market application or premarket report 

19 under section 515 or a premarket applica20 tion under section 351 of the Public 

21 Health Service Act.’’; and 

22 (iii) in paragraph (8), in the matter 

23 preceding subparagraph (A), by inserting 

24 ‘‘(whether domestic or international)’’ after 

25 ‘‘second business entity’’; and 
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1 (B) in section 738—

2 (i) in subsection (d)(2)(B), beginning 

3 in the second sentence, by striking ‘‘firms. 

4 which show’’ and inserting ‘‘firms, which 

5 show’’; 

6 (ii) in subsection (e)—

7 (I) in paragraph (1), by striking 

8 ‘‘Where’’ and inserting ‘‘For fiscal 

9 year 2004 and each subsequent fiscal 

10 year, where’’; and 

11 (II) in paragraph (2)—

12 (aa) in subparagraph (B), 

13 beginning in the second sentence, 

14 by striking ‘‘firms. which show’’ 

15 and inserting ‘‘firms, which 

16 show’’; and 

17 (bb) in subparagraph (C)(i), 

18 by striking ‘‘Where’’ and insert19 ing ‘‘For fiscal year 2004 and 

20 each subsequent fiscal year, 

21 where’’; 

22 (iii) in subsection (f), by striking ‘‘for 

23 filing’’ and inserting ‘‘for review’’; and 

24 (iv) in subsection (h)(2)—
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1 (I) in subparagraph (A), by strik2 ing clause (ii) and inserting the fol3 lowing: 

4 ‘‘(ii) shall only be collected and avail5 able to defray increases in the costs of the 

6 resources allocated for the purposes for the 

7 review of device applications (including in8 creases in such costs for an additional 

9 number of full-time equivalent positions in 

10 the Department of Health and Human 

11 Services to be engaged in such process) 

12 over such costs for fiscal year 2002 when 

13 multiplied by the adjustment factor. 

14 For purposes of this subparagraph, the deter15 mination of the costs of the resources allocated 

16 for the process for the review of device applica17 tions for fiscal year 2003 through 2007 shall 

18 not include costs paid from fees collected under 

19 this section.’’; and 

20 (II) in subparagraph (B), by in21 serting after and below clause (ii)((II) 

22 the following: 

23 ‘‘To the extent such costs are more than 5 per24 cent below the level specified in subparagraph 
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1 (A)(ii), fees may not be collected under this sec2 tion for that fiscal year.’’. 

3 (b) TITLE II; AMENDMENTS REGARDING REGULA4 TION OF MEDICAL DEVICES.—

5 (1) INSPECTIONS BY ACCREDITED PERSONS.—

6 Section 704(g) of the Federal Food, Drug, and Cos7 metic Act (21 U.S.C. 374(g)), as added by section 

8 201 of Public Law 107–250 (116 Stat. 1602), is 

9 amended—

10 (A) in paragraph (1), in the first sentence, 

11 by striking ‘‘conducting inspections’’ and all 

12 that follows and inserting the following: ‘‘con13 ducting inspections of establishments that man14 ufacture, prepare, propagate, compound, or 

15 process class II or class III devices, which in16 spections are required in section 510(h) or are 

17 inspections of such establishments required to 

18 register under section 510(i).’’; 

19 (B) in paragraph (6)(A)—

20 (i) in the matter preceding clause (i), 

21 by inserting ‘‘during a two-year period’’ 

22 after ‘‘paragraph (2)’’; 

23 (ii) in clause (i), by striking ‘‘most re24 cent inspection’’ and all that follows 

25 through ‘‘section 510 as’’ and inserting 
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1 ‘‘most recent inspection described in para2 graph (1) as’’; 

3 (iii) in clause (ii)—

4 (I) in the matter preceding sub5 clause (I), by striking ‘‘With respect 

6 to’’ and all that follows and inserting 

7 the following: ‘‘With respect to the in8 spections to be conducted by an ac9 credited person during such two-year 

10 period—’’; 

11 (II) in subclause (I), by striking 

12 ‘‘such a person to conduct the inspec13 tion,’’ and inserting ‘‘an accredited 

14 person to conduct the inspections,’’; 

15 and 

16 (III) in subclause (II), by strik17 ing ‘‘the inspection,’’ and inserting 

18 ‘‘the inspections,’’; 

19 (iv) in clause (iii)—

20 (I) in the matter preceding sub21 clause (I), by striking ‘‘United 

22 States,’’ and all that follows and in23 serting ‘‘United States, and—’’; 

24 (II) in subclause (I)—
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1 (aa) by striking ‘‘At least 

2 one’’ and inserting ‘‘at least 

3 one’’; and 

4 (bb) by striking ‘‘identified 

5 under subclause (II) of this 

6 clause.’’ and inserting ‘‘identified 

7 under clause (ii)(II); or’’; and 

8 (III) in subclause (II), by strik9 ing ‘‘The owner’’ and inserting ‘‘the 

10 owner’’; and 

11 (v) in clause (iv)—

12 (I) in subclause (I), in the first 

13 sentence, by striking ‘‘In the case of’’ 

14 and all that follows through ‘‘except 

15 that’’ and inserting the following: ‘‘In 

16 the case of inspections to be con17 ducted pursuant to section 510(h), 

18 persons accredited under paragraph 

19 (2) did not conduct any inspection of 

20 the establishment during the two pre21 ceding two-year periods referred to in 

22 such section with respect to the estab23 lishment, except that’’; 

24 (II) in subclause (II), by striking ‘‘In 

25 the case of’’ and all that follows through 
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1 ‘‘the Secretary’’ and inserting the fol2 lowing: ‘‘In the case of inspections to be 

3 conducted of a device establishment re4 quired to register under section 510(i), the 

5 Secretary’’; 

6 (C) in paragraph (6)(B)—

7 (i) in clause (iii)—

8 (I) by striking ‘‘and data other9 wise’’ in the first sentence and all that 

10 follows through ‘‘reports of inspec11 tions regarding’’ in the second sen12 tence and inserting the following: 

13 ‘‘and data describing compliance with 

14 other applicable provisions of this Act. 

15 Such data shall include reports of 

16 inspectional findings regarding’’; and 

17 (II) in the second sentence, by 

18 striking ‘‘establishment, together 

19 with’’ and all that follows and insert20 ing ‘‘establishment.’’; and 

21 (ii) in clause (v), by adding at the end 

22 the following subclause: 

23 ‘‘(III) The agreement (or deemed agreement) of 

24 the Secretary under this subparagraph to the selec25 tion of an accredited person is effective for the two-
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1 year period referred to in the matter preceding 

2 clause (i) of subparagraph (A), subject to paragraph 

3 (5)(B).’’; 

4 (D) in paragraph (6)(C)(ii), in the last 

5 sentence, by inserting before the period the fol6 lowing: ‘‘and may submit a notice under sub7 paragraph (A)’’; 

8 (E) in paragraph (10)(B)(iii), by striking 

9 ‘‘a reporting’’ and inserting ‘‘a report’’; and 

10 (F) in paragraph (12)—

11 (i) in subparagraph (A), by striking 

12 ‘‘the number of’’ the first place such term 

13 appears and all that follows and inserting 

14 the following: ‘‘the number of inspections 

15 conducted by accredited persons pursuant 

16 to this subsection and the number of in17 spections conducted by Federal employees 

18 pursuant to section 510(h) and of device 

19 establishments required to register under 

20 section 510(i);’’; and 

21 (ii) in subparagraph (E), by striking 

22 ‘‘obtained by the Secretary’’ and all that 

23 follows and inserting ‘‘obtained by the Sec24 retary pursuant to inspections conducted 

25 by Federal employees;’’. 
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1 (2) OTHER CORRECTIONS.—Chapter V of the 

2 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

3 351 et seq.), as amended by sections 204 and 206 

4 of Public Law 107–250 (116 Stat. 1611, 1613), is 

5 amended—

6 (A) in section 502(f), in the last sen7 tence—

8 (i) by striking ‘‘requirements of law 

9 and, that’’ and inserting ‘‘requirements of 

10 law, that’’; and 

11 (ii) by striking ‘‘and after such re12 quest, promptly provides’’ and inserting 

13 ‘‘and that, after receiving such request, the 

14 manufacturer promptly provides’’; and 

15 (B) in section 503(g)(4)(A), in the second 

16 sentence, by striking ‘‘shall, in determining 

17 whether’’ and all that follows through ‘‘consult’’ 

18 and inserting the following: ‘‘shall, in deter19 mining whether the product to be assigned is

20 appropriately classified as a combination prod21 uct, consult’’. 

22 (c) TITLE III; ADDITIONAL AMENDMENTS.—

23 (1) IN GENERAL.—The Federal Food, Drug, 

24 and Cosmetic Act (21 U.S.C. 301 et seq.), as 
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1 amended by sections 301 and 302 of Public Law 

2 107–250 (116 Stat. 1616), is amended—

3 (A) in section 502 (21 U.S.C. 352)—

4 (i) by striking paragraph (u); and 

5 (ii) by redesignating paragraph (v) as 

6 paragraph (u); and 

7 (B) in section 510(o) (21 U.S.C. 360(o))—

8 (i) in paragraph (1)(B), in the third 

9 sentence, by striking ‘‘misbranded under 

10 section 502(o), adulterated under’’ and in11 serting ‘‘misbranded under section 502(o) 

12 or adulterated under’’; and 

13 (ii) in paragraph (2)—

14 (I) in subparagraph (B), in the 

15 third sentence, by striking ‘‘mis16 branded under section 502(o), adul17 terated under’’ and inserting ‘‘mis18 branded under section 502(o) or adul19 terated under’’; and 

20 (II) in subparagraph (E), by 

21 striking ‘‘semicritical’’ and inserting 

22 ‘‘semi-critical’’. 

23 (2) CONFORMING AMENDMENT.—Section 301 

24 of Public Law 107–250 (116 Stat. 1616) is amend25 ed by striking subsection (b). 
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1 (d) MISCELLANEOUS CORRECTIONS.—

2 (1) CERTAIN AMENDMENTS REGARDING SEC3 TION 515(c).—

4 (A) IN GENERAL.—Section 515(c) of the 

5 Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 360e), as amended by sections 209 and 

7 302(c)(2)(A) of Public Law 107–250 (116 Stat. 

8 1613, 1618), is amended—

9 (i) by redesignating the second para10 graph (3) (added by section 209 of such 

11 Public Law) as paragraph (4); and 

12 (ii) in paragraph (4) (as so redesig13 nated), in subparagraph (B), by striking 

14 ‘‘an issue’’ and inserting ‘‘a new issue’’. 

15 (B) CONFORMING AMENDMENT.—Section 

16 210 of Public Law 107–250 (116 Stat. 1614) 

17 is amended by striking ‘‘, as amended’’ and all 

18 that follows through ‘‘by adding’’ and inserting 

19 the following: ‘‘is amended in paragraph (3), as 

20 redesignated by section 302(c)(2)(A) of this 

21 Act, by adding’’. 

22 (2) CONFORMING AMENDMENTS REGARDING

23 REFERENCES TO SECTION 738(a).—

24 (A) IN GENERAL.—Section 738 of the Fed25 eral Food, Drug, and Cosmetic Act (21 U.S.C. 
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1 379j), as amended by subparagraph (A) of this 

2 paragraph, is amended—

3 (i) in subsection (d)(1), in the last 

4 sentence, by striking ‘‘clauses (i) through 

5 (vi) of subsection (a)(1)(A)’’ and inserting 

6 ‘‘subparagraphs (A) through (F) of sub7 section (a)(1)’’; 

8 (ii) in subsection (e)(1), by striking 

9 ‘‘subsection (a)(1)(A)(vii)’’ and inserting 

10 ‘‘subsection (a)(1)(G)’’; 

11 (iii) in subsection (e)(2)(C)—

12 (I) in each of clauses (i) and (ii), 

13 by striking ‘‘subsection (a)(1)(A)(vii)’’ 

14 and inserting ‘‘subsection (a)(1)(G)’’; 

15 and 

16 (II) in clause (ii), by striking 

17 ‘‘subsection (a)(1)(A)(i)’’ and insert18 ing ‘‘subsection (a)(1)(A)’’; and 

19 (iv) in subsection (j), by striking 

20 ‘‘subsection (a)(1)(D),’’ and inserting 

21 ‘‘subsection (a)(4),’’. 

22 (B) ADDITIONAL CONFORMING AMEND23 MENT.—Section 102(b)(1) of Public Law 107–

24 250 (116 Stat. 1600) is amended in the matter 

25 preceding subparagraph (A) by striking ‘‘sec-
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1 tion 738(a)(1)(A)(ii)’’ and inserting ‘‘section 

2 738(a)(1)(B)’’. 

3 (3) PUBLIC LAW 107–250.—Public Law 107–

4 250 is amended—

5 (A) in section 102—

6 (i) in subsection (a) (116 Stat. 1589), 

7 by striking ‘‘(21 U.S.C. 379F et seq.)’’ 

8 and inserting ‘‘(21 U.S.C. 379f et seq.)’’; 

9 and 

10 (ii) in subsection (b) (116 Stat. 

11 1600), by striking paragraph (2); 

12 (B) in section 212(b)(2) (116 Stat. 1614), 

13 by striking ‘‘medical devices, such as phase IV 

14 trials, and’’ and inserting ‘‘medical devices 

15 and’’; and 

16 (C) in section 214(a)(3) (116 Stat. 1615), 

17 by striking ‘‘discussion’’ and inserting ‘‘presen18 tation’’. 

19 (4) PUBLIC HEALTH SERVICE ACT.—Section 

20 498C of the Public Health Service Act (42 U.S.C. 

21 289g–3), as added by section 215(b) of Public Law 

22 107–250 (116 Stat. 1615), is amended in subsection 

23 (a) by striking ‘‘Director of NIH may’’ and inserting 

24 ‘‘Director of NIH shall’’. 
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1 (e) HUMANITARIAN DEVICE EXEMPTION; PEDIATRIC

2 PATIENTS.—Section 520(m)(3) of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 360j(m)(3)) is amend4 ed—

5 (1) by striking ‘‘(3) No person’’ and inserting 

6 ‘‘(3)(A) Except as provided in subparagraph (B), no 

7 person’’; and 

8 (2) by adding at the end the following: 

9 ‘‘(B)(i) Subparagraph (A) does not apply with re10 spect to any device intended for the treatment or diagnosis 

11 of a pediatric condition. 

12 ‘‘(ii) For purposes of this subsection: 

13 ‘‘(I) The term ‘pediatric condition’ means a dis14 ease, disorder, or other condition unique to, more se15 rious, or more prevalent in pediatric patients. 

16 ‘‘(II) The term ‘pediatric patient’ means a pa17 tient who is under 15 years of age at the time of 

18 diagnosis or treatment.’’.

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