II 

108TH CONGRESS 

1ST SESSION S. 1881

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 SENATE OF THE UNITED STATES 

NOVEMBER 18, 2003

Mr. ALEXANDER (for himself, Mrs. MURRAY, Mr. ENZI, and Mr. GREGG) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

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’’. 
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•S 1881 IS 

1 SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC 

2 LAW 107–250. 

3 (a) TITLE I; FEES RELATING TO MEDICAL DE4 VICES.—Part 3 of subchapter C of chapter VII of the Fed5 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379i et 

6 seq.), as added by section 102 of Public Law 107–250 

7 (116 Stat. 1589), is amended—

8 (1) in section 737—

9 (A) in paragraph (4)(B), by striking ‘‘and 

10 for which clinical data are generally necessary 

11 to provide a reasonable assurance of safety and 

12 effectiveness’’ and inserting ‘‘and for which sub13 stantial clinical data are necessary to provide a 

14 reasonable assurance of safety and effective15 ness’’; 

16 (B) in paragraph (4)(D), by striking 

17 ‘‘manufacturing,’’; 

18 (C) in paragraph (5)(J), by striking ‘‘a 

19 premarket application’’ and all that follows and 

20 inserting ‘‘a premarket application or pre21 market report under section 515 or a pre22 market application under section 351 of the 

23 Public Health Service Act.’’; and 

24 (D) in paragraph (8), by striking ‘‘The 

25 term ‘affiliate’ means a business entity that has 

26 a relationship with a second business entity’’ 
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•S 1881 IS 

1 and inserting ‘‘The term ‘affiliate’ means a 

2 business entity that has a relationship with a 

3 second business entity (whether domestic or 

4 international)’’; and 

5 (2) in section 738—

6 (A) in subsection (a)(1)—

7 (i) in subparagraph (A)—

8 (I) in the matter preceding clause 

9 (i) by striking ‘‘subsection (d),’’ and 

10 inserting ‘‘subsections (d) and (e),’’; 

11 (II) in clause (iv), by striking 

12 ‘‘clause (i),’’ and all that follows and 

13 inserting ‘‘clause (i).’’; and 

14 (III) in clause (vii), by striking 

15 ‘‘clause (i),’’ and all that follows and 

16 inserting ‘‘clause (i), subject to any 

17 adjustment under subsection 

18 (e)(2)(C)(ii).’’; and 

19 (ii) in subparagraph (D), in each of 

20 clauses (i) and (ii), by striking ‘‘applica21 tion’’ and inserting ‘‘application, report,’’; 

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

23 the second sentence, by striking ‘‘firms. which 

24 show’’ and inserting ‘‘firms, which show’’; 

25 (C) in subsection (e)—
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1 (i) in paragraph (1), by striking 

2 ‘‘Where’’ and inserting ‘‘For fiscal year 

3 2004 and each subsequent fiscal year, 

4 where’’; and 

5 (ii) in paragraph (2)—

6 (I) in subparagraph (B), begin7 ning in the second sentence, by strik8 ing ‘‘firms. which show’’ and inserting 

9 ‘‘firms, which show’’; and 

10 (II) in subparagraph (C)(i), by 

11 striking ‘‘Where’’ and inserting ‘‘For 

12 fiscal year 2004 and each subsequent 

13 fiscal year, where’’; 

14 (D) in subsection (f), by striking ‘‘for fil15 ing’’; and 

16 (E) in subsection (h)(2)—

17 (i) by striking subparagraph (A)(ii) 

18 and inserting the following: 

19 ‘‘(ii) shall only be collected and avail20 able to defray increases in the costs of the 

21 resources allocated for the process for the 

22 review of device applications (including in23 creases in such costs for an additional 

24 number of full-time equivalent positions in 

25 the Department of Health and Human 
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1 Services to be engaged in such process) 

2 over such costs for fiscal year 2002 when

3 multiplied by the adjustment factor (the 

4 determination of the costs of the resources 

5 allocated for the process for the review of 

6 device applications for fiscal year 2003 

7 through 2007, for purposes of this sub8 paragraph, shall not include costs paid 

9 from fees collected under this section).’’; 

10 and 

11 (ii) in subparagraph (B)—

12 (I) in clause (ii), by redesignating 

13 subclauses (I) and (II) as items (aa) 

14 and (bb), respectively; 

15 (II) by redesignating clauses (i) 

16 and (ii) as subclauses (I) and (II), re17 spectively; 

18 (III) by striking ‘‘The Secretary’’ 

19 and inserting the following: 

20 ‘‘(i) IN GENERAL.—The Secretary’’; 

21 and 

22 (IV) by adding at the end the fol23 lowing: 

24 ‘‘(ii) MORE THAN 5 PERCENT.—To 

25 the extent such costs are more than 5 per-
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1 cent below the specified level in subpara2 graph (A)(ii), fees may not be collected 

3 under this section for that fiscal year.’’. 

4 (b) TITLE II; AMENDMENTS REGARDING REGULA5 TION OF MEDICAL DEVICES.—

6 (1) INSPECTIONS BY ACCREDITED PERSONS.—

7 Section 704(g) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 374(g)), as added by section 

9 201 of Public Law 107–250 (116 Stat. 1602), is 

10 amended—

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

12 by striking ‘‘conducting inspections’’ and all 

13 that follows and inserting ‘‘conducting inspec14 tions of establishments that manufacture, pre15 pare, propagate, compound, or process class II 

16 or class III devices, which inspections are re17 quired under section 510(h) or are inspections 

18 of such establishments required to register 

19 under section 510(i).’’; 

20 (B) in paragraph (6)(A)—

21 (i) in clause (i), by striking ‘‘of the es22 tablishment pursuant to subsection (h) or 

23 (i) of section 510’’ and inserting ‘‘de24 scribed in paragraph (1)’’; 

25 (ii) in clause (ii)—
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1 (I) in the matter preceding sub2 clause (I)—

3 (aa) by striking ‘‘each in4 spection’’ and inserting ‘‘inspec5 tions’’; and 

6 (bb) by inserting ‘‘during a 

7 2-year period’’ after ‘‘person’’; 

8 and 

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

10 ‘‘such a person’’ and inserting ‘‘an ac11 credited person’’; 

12 (iii) in clause (iii)—

13 (I) in the matter preceding sub14 clause (I), by striking ‘‘and the fol15 lowing additional conditions are met:’’ 

16 and inserting ‘‘and 1 or both of the 

17 following additional conditions are 

18 met:’’; 

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

20 ‘‘under subclause (II) of this clause’’ 

21 and inserting ‘‘under clause (ii)(II)’’; 

22 and 

23 (III) in subclause (II), by insert24 ing ‘‘or by a person accredited under 
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1 paragraph (2)’’ after ‘‘by the Sec2 retary’’; 

3 (iv) in clause (iv)(I)—

4 (I) in the first sentence—

5 (aa) by striking ‘‘the two 

6 immediately preceding inspec7 tions of the establishment’’ and 

8 inserting ‘‘inspections of the es9 tablishment during the previous 

10 4 years’’; and 

11 (bb) by inserting ‘‘section’’ 

12 after ‘‘pursuant to’’; and 

13 (II) in the third sentence—

14 (aa) by striking ‘‘the peti15 tion states a commercial reason 

16 for the waiver;’’; and 

17 (bb) by inserting ‘‘not’’ after 

18 ‘‘the Secretary has not deter19 mined that the public health 

20 would’’; and 

21 (v) in clause (iv)(II)—

22 (I) by inserting ‘‘of a device es23 tablishment required to register’’ after 

24 ‘‘to be conducted’’; and
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•S 1881 IS 

1 (II) by inserting ‘‘section’’ after 

2 ‘‘pursuant to’’; 

3 (C) in paragraph (6)(B)(iii)—

4 (i) in the first sentence, by striking ‘‘, 

5 and data otherwise describing whether the 

6 establishment has consistently been in 

7 compliance with sections 501 and 502’’; 

8 and 

9 (ii) in the second sentence—

10 (I) by striking ‘‘inspections’’ and 

11 inserting ‘‘inspectional findings’’; and 

12 (II) by striking ‘‘, together with 

13 all other compliance data the Sec14 retary deems necessary’’; 

15 (D) in paragraph (6)(C)(ii), by striking ‘‘in 

16 accordance with section 510(h), or has not dur17 ing such period been inspected pursuant to sec18 tion 510(i), as applicable’’; 

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

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

21 (F) in paragraph (12)—

22 (i) by striking subparagraph (A) and 

23 inserting the following: 

24 ‘‘(A) the number of inspections conducted 

25 by accredited persons pursuant to this sub-
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1 section and the number of inspections con2 ducted by Federal employees pursuant to sec3 tion 510(h) and of device establishments re4 quired to register under section 510(i);’’; and 

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

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

7 follows and inserting ‘‘obtained by the Sec8 retary pursuant to inspections conducted 

9 by Federal employees;’’. 

10 (2) OTHER CORRECTIONS.—Section 502(f) of 

11 the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 352(f)), as amended by section 206 of Public 

13 Law 107–250 (116 Stat. 1613), is amended, in the 

14 last sentence—

15 (A) by inserting ‘‘or by a health care pro16 fessional and required labeling for in vitro diag17 nostic devices intended for use by health care 

18 professionals or in blood establishments’’ after 

19 ‘‘in health care facilities’’; 

20 (B) by inserting a comma after ‘‘means’’; 

21 (C) by striking ‘‘requirements of law and, 

22 that’’ and inserting ‘‘requirements of law, and 

23 that’’; 

24 (D) by striking ‘‘the manufacturer affords 

25 health care facilities the opportunity’’ and in-
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1 serting ‘‘the manufacturer affords such users 

2 the opportunity’’; and 

3 (E) by striking ‘‘the health care facility’’. 

4 (c) TITLE III; ADDITIONAL AMENDMENTS.—Section 

5 510(o) of the Federal Food, Drug, and Cosmetic Act (21 

6 U.S.C. 360(o)), as added by section 302(b) of Public Law 

7 107–250 (116 Stat. 1616), is amended—

8 (1) in paragraph (1)(B), by striking ‘‘, adulter9 ated’’ and inserting ‘‘or adulterated’’; and 

10 (2) in paragraph (2)—

11 (A) in subparagraph (B), by striking ‘‘, 

12 adulterated’’ and inserting ‘‘or adulterated’’; 

13 and 

14 (B) in subparagraph (E), by striking 

15 ‘‘semicritical’’ and inserting ‘‘semi-critical’’. 

16 (d) MISCELLANEOUS CORRECTIONS.—

17 (1) CERTAIN AMENDMENTS TO SECTION 515.—

18 (A) IN GENERAL.—

19 (i) TECHNICAL CORRECTION.—Section 

20 515(c) of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 360e(c)), as 

22 amended by sections 209 and 302(c)(2)(A) 

23 of Public Law 107–250 (116 Stat. 1613, 

24 1618), is amended by redesignating para-
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1 graph (3) (as added by section 209 of such 

2 Public Law) as paragraph (4). 

3 (ii) MODULAR REVIEW.—Section 

4 515(c)(4)(B) of the Federal Food, Drug, 

5 and Cosmetic Act (21 U.S.C. 

6 360e(c)(4)(B)) is amended by striking 

7 ‘‘unless an issue of safety’’ and inserting 

8 ‘‘unless a significant issue of safety’’. 

9 (B) CONFORMING AMENDMENT.—Section 

10 210 of Public Law 107–250 (116 Stat. 1614) 

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

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

13 ‘‘is amended in paragraph (3), as redesignated 

14 by section 302(c)(2)(A) of this Act, by adding’’. 

15 (2) CERTAIN AMENDMENTS TO SECTION 738.—

16 (A) IN GENERAL.—Section 738(a) of the 

17 Federal Food, Drug, and Cosmetic Act (21 

18 U.S.C. 379j(a)), as amended by subsection (a), 

19 is amended—

20 (i) in the matter preceding paragraph 

21 (1)—

22 (I) by striking ‘‘(a) TYPES OF

23 FEES.—Beginning on’’ and inserting 

24 the following: 

25 ‘‘(a) TYPES OF FEES.—
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•S 1881 IS 

1 ‘‘(1) IN GENERAL.—Beginning on’’; and 

2 (II) by striking ‘‘this section as 

3 follows:’’ and inserting ‘‘this section.’’; 

4 and 

5 (ii) by striking ‘‘(1) PREMARKET AP6 PLICATION,’’ and inserting the following: 

7 ‘‘(2) PREMARKET APPLICATION,’’. 

8 (B) CONFORMING AMENDMENTS.—Section 

9 738 of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 379j), as amended by subpara11 graph (A), is amended—

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

13 sentence, by striking ‘‘subsection 

14 (a)(1)(A)’’ and inserting ‘‘subsection 

15 (a)(2)(A)’’; 

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

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

18 ‘‘subsection (a)(2)(A)(vii)’’; 

19 (iii) in subsection (e)(2)(C)—

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

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

22 and inserting ‘‘subsection 

23 (a)(2)(A)(vii)’’; and 
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1 (II) in clause (ii), by striking 

2 ‘‘subsection (a)(1)(A)(i)’’ and insert3 ing ‘‘subsection (a)(2)(A)(i)’’; and 

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

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

6 ‘‘subsection (a)(2)(D),’’. 

7 (C) ADDITIONAL CONFORMING AMEND8 MENT.—Section 102(b)(1) of Public Law 107–

9 250 (116 Stat. 1600) is amended, in the matter 

10 preceding subparagraph (A), by striking ‘‘sec11 tion 738(a)(1)(A)(ii)’’ and inserting ‘‘section 

12 738(a)(2)(A)(ii)’’. 

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

14 250 is amended—

15 (A) in section 102(a) (116 Stat. 1589), by 

16 striking ‘‘(21 U.S.C. 379F et seq.)’’ and insert17 ing ‘‘(21 U.S.C. 379f et seq.)’’; 

18 (B) in section 102(b) (116 Stat. 1600)—

19 (i) by striking paragraph (2); 

20 (ii) in paragraph (1), by redesignating 

21 subparagraphs (A) and (B) as paragraphs 

22 (1) and (2), respectively; and 

23 (iii) by striking: 

24 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB25 MITTING PREMARKET REPORTS.—
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1 ‘‘(1) IN GENERAL.—A person submitting a pre2 market report’’ and inserting: 

3 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB4 MITTING PREMARKET REPORTS.—A person submitting a 

5 premarket report’’; 

6 (C) in section 212(b)(2) (116 Stat. 1614), 

7 by striking ‘‘, such as phase IV trials,’’; and 

8 (D) in section 301(b) (116 Stat. 1616), by 

9 striking ‘‘18 months’’ and inserting ‘‘36 

10 months’’. 

11 SEC. 3. HUMANITARIAN DEVICE EXEMPTION AND PEDI12 ATRIC PRODUCTS. 

13 (a) AMENDMENT TO FEDERAL FOOD, DRUG, AND

14 COSMETIC ACT.—Section 520(m)(3) of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 360j(m)(3)) is amend16 ed to read as follows: 

17 ‘‘(3) Excluding devices intended for the treatment or 

18 diagnosis of diseases or conditions that affect pediatric pa19 tients, no person granted an exemption under paragraph 

20 (2) with respect to a device may sell the device for an 

21 amount that exceeds the costs of research and develop22 ment, fabrication, and distribution of the device. The ex23 clusion from the prohibition under the previous sentence 

24 for devices intended for the treatment or diagnosis of dis25 eases or conditions that affect pediatric patients, shall not 
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1 apply in the case of a request for an exemption under 

2 paragraph (2) made on or after October 1, 2007. In this 

3 paragraph, the term ‘pediatric patient’ means a patient 

4 who is 14 years of age or younger at the time of diagnosis 

5 or treatment.’’. 

6 (b) REPORT.—Not later than October 1, 2006, the 

7 Comptroller General of the United States, in consultation 

8 with the Secretary of Health and Human Services, shall 

9 submit to Congress a report that addresses the effective10 ness of section 520(m) of the Federal Food, Drug, and 

11 Cosmetic Act (21 U.S.C. 360j(m)) in ensuring the devel12 opment of devices designed to treat or diagnose diseases 

13 or conditions that affect fewer than 4,000 pediatric pa14 tients in the United States. Such report shall include the 

15 number and importance of devices for pediatric patients 

16 that are receiving exemptions under section 520(m) of the 

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

18 360j(m)).

Æ