II 

Calendar No. 412

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

NOVEMBER 24, 2003

Reported by Mr. GREGG, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

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,
2

•S 1881 RS 

1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medical Devices Tech3 nical Corrections Act’’. 

4 SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC 

5 LAW 107–250. 

6 (a) TITLE I; FEES RELATING TO MEDICAL DE7 VICES.—Part 3 of subchapter C of chapter VII of the Fed8 eral Food, Drug, and Cosmetic Act (21 U.S.C. 379i et 

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

10 (116 Stat. 1589), is amended—

11 (1) in section 737—

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

13 for which clinical data are generally necessary 

14 to provide a reasonable assurance of safety and 

15 effectiveness’’ and inserting ‘‘and for which sub16 stantial clinical data are necessary to provide a 

17 reasonable assurance of safety and effective18 ness’’; 

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

20 ‘‘manufacturing,’’; 

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

22 premarket application’’ and all that follows and 

23 inserting ‘‘a premarket application or pre24 market report under section 515 or a pre25 market application under section 351 of the 

26 Public Health Service Act.’’; and 
3

•S 1881 RS 

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

2 term ‘affiliate’ means a business entity that has 

3 a relationship with a second business entity’’ 

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

5 business entity that has a relationship with a 

6 second business entity (whether domestic or 

7 international)’’; and 

8 (2) in section 738—

9 (A) in subsection (a)(1)—

10 (i) in subparagraph (A)—

11 (I) in the matter preceding clause 

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

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

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

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

16 inserting ‘‘clause (i).’’; and 

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

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

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

20 adjustment under subsection 

21 (e)(2)(C)(ii).’’; and 

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

23 clauses (i) and (ii), by striking ‘‘applica24 tion’’ and inserting ‘‘application, report,’’; 
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1 (B) in subsection (d)(2)(B), beginning in 

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

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

4 (C) in subsection (e)—

5 (i) in paragraph (1), by striking 

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

7 2004 and each subsequent fiscal year, 

8 where’’; and 

9 (ii) in paragraph (2)—

10 (I) in subparagraph (B), begin11 ning in the second sentence, by strik12 ing ‘‘firms. which show’’ and inserting 

13 ‘‘firms, which show’’; and 

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

15 striking ‘‘Where’’ and inserting ‘‘For 

16 fiscal year 2004 and each subsequent 

17 fiscal year, where’’; 

18 (D) in subsection (f), by striking ‘‘for fil19 ing’’; and 

20 (E) in subsection (h)(2)—

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

22 and inserting the following: 

23 ‘‘(ii) shall only be collected and avail24 able to defray increases in the costs of the 

25 resources allocated for the process for the 
5

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1 review of device applications (including in2 creases in such costs for an additional 

3 number of full-time equivalent positions in 

4 the Department of Health and Human 

5 Services to be engaged in such process) 

6 over such costs for fiscal year 2002 when 

7 multiplied by the adjustment factor (the 

8 determination of the costs of the resources 

9 allocated for the process for the review of 

10 device applications for fiscal year 2003 

11 through 2007, for purposes of this sub12 paragraph, shall not include costs paid 

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

14 and 

15 (ii) in subparagraph (B)—

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

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

18 and (bb), respectively; 

19 (II) by redesignating clauses (i) 

20 and (ii) as subclauses (I) and (II), re21 spectively; 

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

23 and inserting the following: 

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

25 and 
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1 (IV) by adding at the end the fol2 lowing: 

3 ‘‘(ii) MORE THAN 5 PERCENT.—To 

4 the extent such costs are more than 5 per5 cent below the specified level in subpara6 graph (A)(ii), fees may not be collected 

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

8 (b) TITLE II; AMENDMENTS REGARDING REGULA9 TION OF MEDICAL DEVICES.—

10 (1) INSPECTIONS BY ACCREDITED PERSONS.—

11 Section 704(g) of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 374(g)), as added by section 

13 201 of Public Law 107–250 (116 Stat. 1602), is 

14 amended—

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

16 by striking ‘‘conducting inspections’’ and all 

17 that follows and inserting ‘‘conducting inspec18 tions of establishments that manufacture, pre19 pare, propagate, compound, or process class II 

20 or class III devices, which inspections are re21 quired under section 510(h) or are inspections 

22 of such establishments required to register 

23 under section 510(i).’’; 

24 (B) in paragraph (6)(A)—
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1 (i) in clause (i), by striking ‘‘of the es2 tablishment pursuant to subsection (h) or 

3 (i) of section 510’’ and inserting ‘‘de4 scribed in paragraph (1)’’; 

5 (ii) in clause (ii)—

6 (I) in the matter preceding sub7 clause (I)—

8 (aa) by striking ‘‘each in9 spection’’ and inserting ‘‘inspec10 tions’’; and 

11 (bb) by inserting ‘‘during a 

12 2-year period’’ after ‘‘person’’; 

13 and 

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

15 ‘‘such a person’’ and inserting ‘‘an ac16 credited person’’; 

17 (iii) in clause (iii)—

18 (I) in the matter preceding sub19 clause (I), by striking ‘‘and the fol20 lowing additional conditions are met:’’ 

21 and inserting ‘‘and 1 or both of the 

22 following additional conditions are 

23 met:’’; 

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

25 ‘‘under subclause (II) of this clause’’ 
8

•S 1881 RS 

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

2 and 

3 (III) in subclause (II), by insert4 ing ‘‘or by a person accredited under 

5 paragraph (2)’’ after ‘‘by the Sec6 retary’’; 

7 (iv) in clause (iv)(I)—

8 (I) in the first sentence—

9 (aa) by striking ‘‘the two 

10 immediately preceding inspec11 tions of the establishment’’ and 

12 inserting ‘‘inspections of the es13 tablishment during the previous 

14 4 years’’; and 

15 (bb) by inserting ‘‘section’’ 

16 after ‘‘pursuant to’’; and 

17 (II) in the third sentence—

18 (aa) by striking ‘‘the peti19 tion states a commercial reason 

20 for the waiver;’’; and 

21 (bb) by inserting ‘‘not’’ after 

22 ‘‘the Secretary has not deter23 mined that the public health 

24 would’’; and 

25 (v) in clause (iv)(II)—
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1 (I) by inserting ‘‘of a device es2 tablishment required to register’’ after 

3 ‘‘to be conducted’’; and 

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

5 ‘‘pursuant to’’; 

6 (C) in paragraph (6)(B)(iii)—

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

8 and data otherwise describing whether the 

9 establishment has consistently been in 

10 compliance with sections 501 and 502’’; 

11 and 

12 (ii) in the second sentence—

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

14 inserting ‘‘inspectional findings’’; and 

15 (II) by striking ‘‘, together with 

16 all other compliance data the Sec17 retary deems necessary’’; 

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

19 accordance with section 510(h), or has not dur20 ing such period been inspected pursuant to sec21 tion 510(i), as applicable’’; 

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

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

24 (F) in paragraph (12)—
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1 (i) by striking subparagraph (A) and 

2 inserting the following: 

3 ‘‘(A) the number of inspections conducted 

4 by accredited persons pursuant to this sub5 section and the number of inspections con6 ducted by Federal employees pursuant to sec7 tion 510(h) and of device establishments re8 quired to register under section 510(i);’’; and 

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

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

11 follows and inserting ‘‘obtained by the Sec12 retary pursuant to inspections conducted 

13 by Federal employees;’’. 

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

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

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

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

18 last sentence—

19 (A) by inserting ‘‘or by a health care pro20 fessional and required labeling for in vitro diag21 nostic devices intended for use by health care 

22 professionals or in blood establishments’’ after 

23 ‘‘in health care facilities’’; 

24 (B) by inserting a comma after ‘‘means’’; 
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1 (C) by striking ‘‘requirements of law and, 

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

3 that’’; 

4 (D) by striking ‘‘the manufacturer affords 

5 health care facilities the opportunity’’ and in6 serting ‘‘the manufacturer affords such users 

7 the opportunity’’; and 

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

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

10 510(o) of the Federal Food, Drug, and Cosmetic Act (21 

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

12 107–250 (116 Stat. 1616), is amended—

13 (1) in paragraph (1)(B), by striking ‘‘, adulter14 ated’’ and inserting ‘‘or adulterated’’; and 

15 (2) in paragraph (2)—

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

17 adulterated’’ and inserting ‘‘or adulterated’’; 

18 and 

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

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

21 (d) MISCELLANEOUS CORRECTIONS.—

22 (1) CERTAIN AMENDMENTS TO SECTION 515.—

23 (A) IN GENERAL.—

24 (i) TECHNICAL CORRECTION.—Section 

25 515(c) of the Federal Food, Drug, and 
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1 Cosmetic Act (21 U.S.C. 360e(c)), as 

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

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

4 1618), is amended by redesignating para5 graph (3) (as added by section 209 of such 

6 Public Law) as paragraph (4). 

7 (ii) MODULAR REVIEW.—Section 

8 515(c)(4)(B) of the Federal Food, Drug, 

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

10 360e(c)(4)(B)) is amended by striking 

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

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

13 (B) CONFORMING AMENDMENT.—Section 

14 210 of Public Law 107–250 (116 Stat. 1614) 

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

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

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

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

19 (2) CERTAIN AMENDMENTS TO SECTION 738.—

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

21 Federal Food, Drug, and Cosmetic Act (21 

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

23 is amended—

24 (i) in the matter preceding paragraph 

25 (1)—
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1 (I) by striking ‘‘(a) TYPES OF

2 FEES.—Beginning on’’ and inserting 

3 the following: 

4 ‘‘(a) TYPES OF FEES.—

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

6 (II) by striking ‘‘this section as 

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

8 and 

9 (ii) by striking ‘‘(1) PREMARKET AP10 PLICATION,’’ and inserting the following: 

11 ‘‘(2) PREMARKET APPLICATION,’’. 

12 (B) CONFORMING AMENDMENTS.—Section 

13 738 of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 379j), as amended by subpara15 graph (A), is amended—

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

17 sentence, by striking ‘‘subsection 

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

19 (a)(2)(A)’’; 

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

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

22 ‘‘subsection (a)(2)(A)(vii)’’; 

23 (iii) in subsection (e)(2)(C)—

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

25 by striking ‘‘subsection (a)(1)(A)(vii)’’ 
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1 and inserting ‘‘subsection 

2 (a)(2)(A)(vii)’’; and 

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

4 ‘‘subsection (a)(1)(A)(i)’’ and insert5 ing ‘‘subsection (a)(2)(A)(i)’’; and 

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

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

8 ‘‘subsection (a)(2)(D),’’. 

9 (C) ADDITIONAL CONFORMING AMEND10 MENT.—Section 102(b)(1) of Public Law 107–

11 250 (116 Stat. 1600) is amended, in the matter 

12 preceding subparagraph (A), by striking ‘‘sec13 tion 738(a)(1)(A)(ii)’’ and inserting ‘‘section 

14 738(a)(2)(A)(ii)’’. 

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

16 250 is amended—

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

18 striking ‘‘(21 U.S.C. 379F et seq.)’’ and insert19 ing ‘‘(21 U.S.C. 379f et seq.)’’; 

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

21 (i) by striking paragraph (2); 

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

23 subparagraphs (A) and (B) as paragraphs 

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

25 (iii) by striking: 
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1 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB2 MITTING PREMARKET REPORTS.—

3 ‘‘(1) IN GENERAL.—A person submitting a pre4 market report’’ and inserting: 

5 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB6 MITTING PREMARKET REPORTS.—A person submitting a 

7 premarket report’’; 

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

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

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

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

12 months’’. 

13 SEC. 3. HUMANITARIAN DEVICE EXEMPTION AND PEDI14 ATRIC PRODUCTS. 

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

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

17 Drug, and Cosmetic Act (21 U.S.C. 360j(m)(3)) is amend18 ed to read as follows: 

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

20 diagnosis of diseases or conditions that affect pediatric pa21 tients, no person granted an exemption under paragraph 

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

23 amount that exceeds the costs of research and develop24 ment, fabrication, and distribution of the device. The ex25 clusion from the prohibition under the previous sentence 
16

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1 for devices intended for the treatment or diagnosis of dis2 eases or conditions that affect pediatric patients, shall not 

3 apply in the case of a request for an exemption under 

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

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

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

7 or treatment.’’. 

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

9 Comptroller General of the United States, in consultation 

10 with the Secretary of Health and Human Services, shall 

11 submit to Congress a report that addresses the effective12 ness of section 520(m) of the Federal Food, Drug, and 

13 Cosmetic Act (21 U.S.C. 360j(m)) in ensuring the devel14 opment of devices designed to treat or diagnose diseases 

15 or conditions that affect fewer than 4,000 pediatric pa16 tients in the United States. Such report shall include the 

17 number and importance of devices for pediatric patients 

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

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

20 360j(m)).

21 SECTION 1. SHORT TITLE. 

22 This Act may be cited as the ‘‘Medical Devices Tech23 nical Corrections Act’’.
17

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1 SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 

2 107–250. 

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 seq.), 

6 as added by section 102 of Public Law 107–250 (116 Stat. 

7 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 to 

11 provide a reasonable assurance of safety and ef12 fectiveness’’ and inserting ‘‘and for which sub13 stantial clinical data are necessary to provide a 

14 reasonable assurance of safety and effectiveness’’; 

15 (B) in paragraph (4)(D), by striking ‘‘man16 ufacturing,’’; 

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

18 premarket application’’ and all that follows and 

19 inserting ‘‘a premarket application or premarket 

20 report under section 515 or a premarket applica21 tion under section 351 of the Public Health Serv22 ice Act.’’; and 

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

24 term ‘affiliate’ means a business entity that has 

25 a relationship with a second business entity’’ 

26 and inserting ‘‘The term ‘affiliate’ means a busi-
18

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1 ness entity that has a relationship with a second 

2 business entity (whether domestic or inter3 national)’’; and 

4 (2) in section 738—

5 (A) in subsection (a)(1)—

6 (i) in subparagraph (A)—

7 (I) in the matter preceding clause 

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

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

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

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

12 inserting ‘‘clause (i).’’; and 

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

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

15 inserting ‘‘clause (i), subject to any ad16 justment under subsection 

17 (e)(2)(C)(ii).’’; and 

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

19 clauses (i) and (ii), by striking ‘‘applica20 tion’’ and inserting ‘‘application, report,’’; 

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

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

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

24 (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 striking 

8 ‘‘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)(B)—

17 (i) in clause (ii), by redesignating sub18 clauses (I) and (II) as items (aa) and (bb), 

19 respectively; 

20 (ii) by redesignating clauses (i) and 

21 (ii) as subclauses (I) and (II), respectively; 

22 (iii) by striking ‘‘The Secretary’’ and 

23 inserting the following: 

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

25 and 
20

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1 (iv) by adding at the end the following: 

2 ‘‘(ii) MORE THAN 5 PERCENT.—To the 

3 extent such costs are more than 5 percent 

4 below the specified level in subparagraph 

5 (A)(ii), fees may not be collected under this 

6 section for that fiscal year.’’. 

7 (b) TITLE II; AMENDMENTS REGARDING REGULATION

8 OF MEDICAL DEVICES.—

9 (1) INSPECTIONS BY ACCREDITED PERSONS.—

10 Section 704(g) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 374(g)), as added by section 201 

12 of Public Law 107–250 (116 Stat. 1602), is amend13 ed—

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

15 by striking ‘‘conducting inspections’’ and all that 

16 follows and inserting ‘‘conducting inspections of 

17 establishments that manufacture, prepare, propa18 gate, compound, or process class II or class III 

19 devices, which inspections are required under 

20 section 510(h) or are inspections of such estab21 lishments required to register under section 

22 510(i).’’; 

23 (B) in paragraph (6)(A)—

24 (i) in clause (i), by striking ‘‘of the es25 tablishment pursuant to subsection (h) or 
21

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1 (i) of section 510’’ and inserting ‘‘described 

2 in paragraph (1)’’; 

3 (ii) in clause (ii)—

4 (I) in the matter preceding sub5 clause (I)—

6 (aa) by striking ‘‘each in7 spection’’ and inserting ‘‘inspec8 tions’’; and 

9 (bb) by inserting ‘‘during a 

10 2-year period’’ after ‘‘person’’; 

11 and 

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

13 ‘‘such a person’’ and inserting ‘‘an ac14 credited person’’; 

15 (iii) in clause (iii)—

16 (I) in the matter preceding sub17 clause (I), by striking ‘‘and the fol18 lowing additional conditions are met:’’ 

19 and inserting ‘‘and 1 or both of the fol20 lowing additional conditions are met:’’; 

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

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

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

24 and
22

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1 (III) in subclause (II), by insert2 ing ‘‘or by a person accredited under 

3 paragraph (2)’’ after ‘‘by the Sec4 retary’’; 

5 (iv) in clause (iv)(I)—

6 (I) in the first sentence—

7 (aa) by striking ‘‘the two im8 mediately preceding inspections of 

9 the establishment’’ and inserting 

10 ‘‘inspections of the establishment 

11 during the previous 4 years’’; and 

12 (bb) by inserting ‘‘section’’ 

13 after ‘‘pursuant to’’; 

14 (II) in the third sentence—

15 (aa) by striking ‘‘the petition 

16 states a commercial reason for the 

17 waiver;’’; and 

18 (bb) by inserting ‘‘not’’ after 

19 ‘‘the Secretary has not determined 

20 that the public health would’’; and 

21 (III) in the fourth sentence, by 

22 striking ‘‘granted until’’ and inserting 

23 ‘‘granted or deemed to be granted 

24 until’’; and 

25 (v) in clause (iv)(II)—
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1 (I) by inserting ‘‘of a device estab2 lishment required to register’’ after ‘‘to 

3 be conducted’’; and 

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

5 ‘‘pursuant to’’; 

6 (C) in paragraph (6)(B)(iii)—

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

8 and data otherwise describing whether the 

9 establishment has consistently been in com10 pliance with sections 501 and 502’’; and 

11 (ii) in the second sentence—

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

13 inserting ‘‘inspectional findings’’; and 

14 (II) by inserting ‘‘relevant’’ after 

15 ‘‘together with all other’’; 

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

17 accordance with section 510(h), or has not dur18 ing such period been inspected pursuant to sec19 tion 510(i), as applicable’’; 

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

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

22 (F) in paragraph (12)—

23 (i) by striking subparagraph (A) and 

24 inserting the following: 
24

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1 ‘‘(A) the number of inspections conducted by 

2 accredited persons pursuant to this subsection 

3 and the number of inspections conducted by Fed4 eral employees pursuant to section 510(h) and of 

5 device establishments required to register under 

6 section 510(i);’’; and 

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

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

9 follows and inserting ‘‘obtained by the Sec10 retary pursuant to inspections conducted by 

11 Federal employees;’’. 

12 (2) OTHER CORRECTIONS.—

13 (A) PROHIBITED ACTS.—Section 301(gg) of 

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

15 U.S.C. 331(gg)), as amended by section 201(d) of 

16 Public Law 107–250 (116 Stat. 1609), is amend17 ed to read as follows: 

18 ‘‘(gg) The knowing failure to comply with paragraph 

19 (7)(E) of section 704(g); the knowing inclusion by a person 

20 accredited under paragraph (2) of such section of false in21 formation in an inspection report under paragraph (7)(A) 

22 of such section; or the knowing failure of such a person to 

23 include material facts in such a report.’’. 

24 (B) ELECTRONIC LABELING.—Section 

25 502(f) of the Federal Food, Drug, and Cosmetic 
25

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1 Act (21 U.S.C. 352(f)), as amended by section 

2 206 of Public Law 107–250 (116 Stat. 1613), is 

3 amended, in the last sentence—

4 (i) by inserting ‘‘or by a health care 

5 professional and required labeling for in 

6 vitro diagnostic devices intended for use by 

7 health care professionals or in blood estab8 lishments’’ after ‘‘in health care facilities’’; 

9 (ii) by inserting a comma after 

10 ‘‘means’’; 

11 (iii) by striking ‘‘requirements of law 

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

13 law, and that’’; 

14 (iv) by striking ‘‘the manufacturer af15 fords health care facilities the opportunity’’ 

16 and inserting ‘‘the manufacturer affords 

17 such users the opportunity’’; and 

18 (v) by striking ‘‘the health care facil19 ity’’. 

20 (c) TITLE III; ADDITIONAL AMENDMENTS.—

21 (1) EFFECTIVE DATE.—Section 301(b) of Public 

22 Law 107–250 (116 Stat. 1616), is amended by strik23 ing ‘‘18 months’’ and inserting ‘‘36 months’’. 

24 (2) PREMARKET NOTIFICATION.—Section 510(o) 

25 of the Federal Food, Drug, and Cosmetic Act (21 
26

•S 1881 RS 

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

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

3 (A) in paragraph (1)(B), by striking ‘‘, 

4 adulterated’’ and inserting ‘‘or adulterated’’; and 

5 (B) in paragraph (2)—

6 (i) in subparagraph (B), by striking ‘‘, 

7 adulterated’’ and inserting ‘‘or adulter8 ated’’; and 

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

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

11 (d) MISCELLANEOUS CORRECTIONS.—

12 (1) CERTAIN AMENDMENTS TO SECTION 515.—

13 (A) IN GENERAL.—

14 (i) TECHNICAL CORRECTION.—Section 

15 515(c) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 360e(c)), as amended 

17 by sections 209 and 302(c)(2)(A) of Public 

18 Law 107–250 (116 Stat. 1613, 1618), is 

19 amended by redesignating paragraph (3) 

20 (as added by section 209 of such Public 

21 Law) as paragraph (4). 

22 (ii) MODULAR REVIEW.—Section 

23 515(c)(4)(B) of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 360e(c)(4)(B)) is 

25 amended by striking ‘‘unless an issue of
27

•S 1881 RS 

1 safety’’ and inserting ‘‘unless a significant 

2 issue of safety’’. 

3 (B) CONFORMING AMENDMENT.—Section 

4 210 of Public Law 107–250 (116 Stat. 1614) is 

5 amended by striking ‘‘, as amended’’ and all that 

6 follows through ‘‘by adding’’ and inserting ‘‘is 

7 amended in paragraph (3), as redesignated by 

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

9 (2) CERTAIN AMENDMENTS TO SECTION 738.—

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

11 Federal Food, Drug, and Cosmetic Act (21 

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

13 amended—

14 (i) in the matter preceding paragraph 

15 (1)—

16 (I) by striking ‘‘(a) TYPES OF

17 FEES.—Beginning on’’ and inserting 

18 the following: 

19 ‘‘(a) TYPES OF FEES.—

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

21 (II) by striking ‘‘this section as 

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

23 and 
28

•S 1881 RS 

1 (ii) by striking ‘‘(1) PREMARKET AP2 PLICATION,’’ and inserting the following: 

3 ‘‘(2) PREMARKET APPLICATION,’’. 

4 (B) CONFORMING AMENDMENTS.—Section 

5 738 of the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 379j), as amended by subparagraph 

7 (A), is amended—

8 (i) in subsection (d)(1), in the last sen9 tence, by striking ‘‘subsection (a)(1)(A)’’ 

10 and inserting ‘‘subsection (a)(2)(A)’’; 

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

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

13 ‘‘subsection (a)(2)(A)(vii)’’; 

14 (iii) in subsection (e)(2)(C)—

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

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

17 and inserting ‘‘subsection 

18 (a)(2)(A)(vii)’’; and 

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

20 ‘‘subsection (a)(1)(A)(i)’’ and inserting 

21 ‘‘subsection (a)(2)(A)(i)’’; and 

22 (iv) in subsection (j), by striking ‘‘sub23 section (a)(1)(D),’’ and inserting ‘‘sub24 section (a)(2)(D),’’. 
29

•S 1881 RS 

1 (C) ADDITIONAL CONFORMING AMEND2 MENT.—Section 102(b)(1) of Public Law 107–

3 250 (116 Stat. 1600) is amended, in the matter 

4 preceding subparagraph (A), by striking ‘‘section 

5 738(a)(1)(A)(ii)’’ and inserting ‘‘section 

6 738(a)(2)(A)(ii)’’. 

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

8 is amended—

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

10 striking ‘‘(21 U.S.C. 379F et seq.)’’ and inserting 

11 ‘‘(21 U.S.C. 379f et seq.)’’; 

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

13 (i) by striking paragraph (2); 

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

15 subparagraphs (A) and (B) as paragraphs 

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

17 (iii) by striking: 

18 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB19 MITTING PREMARKET REPORTS.—

20 ‘‘(1) IN GENERAL.—A person submitting a pre21 market report’’ and inserting: 

22 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB23 MITTING PREMARKET REPORTS.—A person submitting a 

24 premarket report’’; and 
30

•S 1881 RS 

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

2 by striking ‘‘, such as phase IV trials,’’. 

3 SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DE4 VICES INTENDED FOR CHILDREN. 

5 Not later than 180 days after the date of enactment 

6 of this Act, the Secretary of Health and Human Services 

7 shall submit to the Committee on Health, Education, Labor, 

8 and Pensions of the Senate and the Committee on Energy 

9 and Commerce of the House of Representatives a report on 

10 the barriers to the availability of devices intended for the 

11 treatment or diagnosis of diseases and conditions that affect 

12 children. The report shall include any recommendations of 

13 the Secretary of Health and Human Services for changes 

14 to existing statutory authority, regulations, or agency pol15 icy or practice to encourage the invention and development 

16 of such devices.

Calendar No. 412

108TH CONGRESS 

1ST SESSION S. 1881

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. 

NOVEMBER 24, 2003

Reported with an amendment