IB 

Union Calendar No. 250

108TH CONGRESS 

2D SESSION S. 1881

[Report No. 108–433] 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 8, 2003

Referred to the Committee on Energy and Commerce 

MARCH 9, 2004 

Reported with an amendment, committed to the Committee of the Whole 

House on the State of the Union, and ordered to be printed 

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

[For text of Senate passed bill, see copy of bill as referred in the House of Representatives 

on December 8, 2003] 

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.

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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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-
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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 
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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 (5)(B), in the first sen24 tence, by striking ‘‘or poses’’ and all that follows 

25 through the period and inserting ‘‘poses a threat
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1 to public health, fails to act in a manner that 

2 is consistent with the purposes of this subsection, 

3 or where the Secretary determines that there is 

4 a financial conflict of interest in the relationship 

5 between the accredited person and the owner or 

6 operator of a device establishment that the ac7 credited person has inspected under this sub8 section.’’; 

9 (C) in paragraph (6)(A)—

10 (i) in clause (i), by striking ‘‘of the es11 tablishment pursuant to subsection (h) or 

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

13 in paragraph (1)’’; 

14 (ii) in clause (ii)—

15 (I) in the matter preceding sub16 clause (I)—

17 (aa) by striking ‘‘each in18 spection’’ and inserting ‘‘inspec19 tions’’; and 

20 (bb) by inserting ‘‘during a 

21 2-year period’’ after ‘‘person’’; 

22 and 

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

24 ‘‘such a person’’ and inserting ‘‘an ac25 credited person’’; 
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1 (iii) in clause (iii)—

2 (I) in the matter preceding sub3 clause (I), by striking ‘‘and the fol4 lowing additional conditions are met:’’ 

5 and inserting ‘‘and 1 or both of the fol6 lowing additional conditions are met:’’; 

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

8 ‘‘accredited’’ and all that follows 

9 through the period and inserting ‘‘(ac10 credited under paragraph (2) and 

11 identified under clause (ii)(II)) as a 

12 person authorized to conduct such in13 spections of device establishments.’’; 

14 and 

15 (III) in subclause (II), by insert16 ing ‘‘or by a person accredited under 

17 paragraph (2)’’ after ‘‘by the Sec18 retary’’; 

19 (iv) in clause (iv)(I)—

20 (I) in the first sentence—

21 (aa) by striking ‘‘the two im22 mediately preceding inspections of 

23 the establishment’’ and inserting 

24 ‘‘inspections of the establishment 

25 during the previous 4 years’’; and 
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1 (bb) by inserting ‘‘section’’ 

2 after ‘‘pursuant to’’; 

3 (II) in the third sentence—

4 (aa) by striking ‘‘the petition 

5 states a commercial reason for the 

6 waiver;’’; and 

7 (bb) by inserting ‘‘not’’ after 

8 ‘‘the Secretary has not determined 

9 that the public health would’’; and 

10 (III) in the fourth sentence, by 

11 striking ‘‘granted until’’ and inserting 

12 ‘‘granted or deemed to be granted 

13 until’’; and 

14 (v) in clause (iv)(II)—

15 (I) by inserting ‘‘of a device estab16 lishment required to register’’ after ‘‘to 

17 be conducted’’; and 

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

19 ‘‘pursuant to’’; 

20 (D) in paragraph (6)(B)(iii)—

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

22 and data otherwise describing whether the 

23 establishment has consistently been in com24 pliance with sections 501 and 502 and 

25 other’’ and inserting ‘‘and with other’’; and 
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1 (ii) in the second sentence—

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

3 inserting ‘‘inspectional findings’’; and 

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

5 ‘‘together with all other’’; 

6 (E) in paragraph (6)(B)(iv)—

7 (i) by inserting ‘‘(I)’’ after ‘‘(iv)’’; and 

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

9 ‘‘(II) If, during the two-year period following clear10 ance under subparagraph (A), the Secretary determines 

11 that the device establishment is substantially not in compli12 ance with this Act, the Secretary may, after notice and a 

13 written response, notify the establishment that the eligi14 bility of the establishment for the inspections by accredited 

15 persons has been suspended.’’; 

16 (F) 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 (G) in paragraph (10)(B)(iii), by striking 

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

22 (H) in paragraph (12)—

23 (i) by striking subparagraph (A) and 

24 inserting the following: 
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1 ‘‘(A) the number of inspections conducted by ac2 credited persons pursuant to this subsection and the 

3 number of inspections conducted by Federal employees 

4 pursuant to section 510(h) and of device establish5 ments required to register under section 510(i);’’; and 

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

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

8 follows and inserting ‘‘obtained by the Sec9 retary pursuant to inspections conducted by 

10 Federal employees;’’. 

11 (2) OTHER CORRECTIONS.—

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

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

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

15 Public Law 107–250 (116 Stat. 1609), is amend16 ed to read as follows: 

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

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

19 accredited under paragraph (2) of such section of false in20 formation in an inspection report under paragraph (7)(A) 

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

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

23 (B) ELECTRONIC LABELING.—Section 

24 502(f) of the Federal Food, Drug, and Cosmetic 

25 Act (21 U.S.C. 352(f)), as amended by section
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1 206 of Public Law 107–250 (116 Stat. 1613), is 

2 amended, in the last sentence—

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

4 professional and required labeling for in 

5 vitro diagnostic devices intended for use by 

6 health care professionals or in blood estab7 lishments’’ after ‘‘in health care facilities’’; 

8 (ii) by inserting a comma after 

9 ‘‘means’’; 

10 (iii) by striking ‘‘requirements of law 

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

12 law, and that’’; 

13 (iv) by striking ‘‘the manufacturer af14 fords health care facilities the opportunity’’ 

15 and inserting ‘‘the manufacturer affords 

16 such users the opportunity’’; and 

17 (v) by striking ‘‘the health care facil18 ity’’. 

19 (c) TITLE III; ADDITIONAL AMENDMENTS.—

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

21 Law 107–250 (116 Stat. 1616), is amended by strik22 ing ‘‘18 months’’ and inserting ‘‘36 months’’. 

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

24 of the Federal Food, Drug, and Cosmetic Act (21 
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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 
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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 
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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),’’. 
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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 
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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.

Union Calendar No. 250

108TH CONGRESS 

2D SESSION S. 1881

[Report No. 108–433] 

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. 

MARCH 9, 2004

Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, 

and ordered to be printed