108TH CONGRESS

1ST SESSION S. 1881

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

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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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)(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 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’’
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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’’;

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
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1 (III) in the fourth sentence, by

2 striking ‘‘granted until’’ and inserting

3 ‘‘granted or deemed to be granted

4 until’’; and

5 (v) in clause (iv)(II)—

6 (I) by inserting ‘‘of a device es7 tablishment required to register’’ after

8 ‘‘to be conducted’’; and

9 (II) by inserting ‘‘section’’ after

10 ‘‘pursuant to’’;

11 (C) in paragraph (6)(B)(iii)—

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

13 and data otherwise describing whether the

14 establishment has consistently been in

15 compliance with sections 501 and 502’’;

16 and

17 (ii) in the second sentence—

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

19 inserting ‘‘inspectional findings’’; and

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

21 ‘‘together with all other’’;

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

23 accordance with section 510(h), or has not dur24 ing such period been inspected pursuant to sec25 tion 510(i), as applicable’’;
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1 (E) in paragraph (10)(B)(iii), by striking

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

3 (F) in paragraph (12)—

4 (i) by striking subparagraph (A) and

5 inserting the following:

6 ‘‘(A) the number of inspections conducted

7 by accredited persons pursuant to this sub8 section and the number of inspections con9 ducted by Federal employees pursuant to sec10 tion 510(h) and of device establishments re11 quired to register under section 510(i);’’; and

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

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

14 follows and inserting ‘‘obtained by the Sec15 retary pursuant to inspections conducted

16 by Federal employees;’’.

17 (2) OTHER CORRECTIONS.—

18 (A) PROHIBITED ACTS.—Section 301(gg)

19 of the Federal Food, Drug, and Cosmetic Act

20 (21 U.S.C. 331(gg)), as amended by section

21 201(d) of Public Law 107–250 (116 Stat.

22 1609), is amended to read as follows:

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

24 (7)(E) of section 704(g); the knowing inclusion by a per25 son accredited under paragraph (2) of such section of false
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1 information in an inspection report under paragraph

2 (7)(A) of such section; or the knowing failure of such a

3 person to include material facts in such a report.’’.

4 (B) ELECTRONIC LABELING.—Section

5 502(f) of the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 352(f)), as amended by

7 section 206 of Public Law 107–250 (116 Stat.

8 1613), is amended, in the last sentence—

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

10 professional and required labeling for in

11 vitro diagnostic devices intended for use by

12 health care professionals or in blood estab13 lishments’’ after ‘‘in health care facilities’’;

14 (ii) by inserting a comma after

15 ‘‘means’’;

16 (iii) by striking ‘‘requirements of law

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

18 law, and that’’;

19 (iv) by striking ‘‘the manufacturer af20 fords health care facilities the opportunity’’

21 and inserting ‘‘the manufacturer affords

22 such users the opportunity’’; and

23 (v) by striking ‘‘the health care facil24 ity’’.

25 (c) TITLE III; ADDITIONAL AMENDMENTS.—
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1 (1) EFFECTIVE DATE.—Section 301(b) of Pub2 lic Law 107–250 (116 Stat. 1616), is amended by

3 striking ‘‘18 months’’ and inserting ‘‘36 months’’.

4 (2) PREMARKET NOTIFICATION.—Section

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

6 (21 U.S.C. 360(o)), as added by section 302(b) of

7 Public Law 107–250 (116 Stat. 1616), is

8 amended—

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

10 adulterated’’ and inserting ‘‘or adulterated’’;

11 and

12 (B) in paragraph (2)—

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

14 adulterated’’ and inserting ‘‘or adulter15 ated’’; and

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

17 ‘‘semicritical’’ and inserting ‘‘semi-crit18 ical’’.

19 (d) MISCELLANEOUS CORRECTIONS.—

20 (1) CERTAIN AMENDMENTS TO SECTION 515.—

21 (A) IN GENERAL.—

22 (i) TECHNICAL CORRECTION.—Section

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

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

25 amended by sections 209 and 302(c)(2)(A)
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1 of Public Law 107–250 (116 Stat. 1613,

2 1618), is amended by redesignating para3 graph (3) (as added by section 209 of such

4 Public Law) as paragraph (4).

5 (ii) MODULAR REVIEW.—Section

6 515(c)(4)(B) of the Federal Food, Drug,

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

8 360e(c)(4)(B)) is amended by striking

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

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

11 (B) CONFORMING AMENDMENT.—Section

12 210 of Public Law 107–250 (116 Stat. 1614)

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

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

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

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

17 (2) CERTAIN AMENDMENTS TO SECTION 738.—

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

19 Federal Food, Drug, and Cosmetic Act (21

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

21 is amended—

22 (i) in the matter preceding paragraph

23 (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’’; and

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

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

10 SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DE11 VICES INTENDED FOR CHILDREN.

12 Not later than 180 days after the date of enactment

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

14 shall submit to the Committee on Health, Education,

15 Labor, and Pensions of the Senate and the Committee on

16 Energy and Commerce of the House of Representatives

17 a report on the barriers to the availability of devices in18 tended for the treatment or diagnosis of diseases and con19 ditions that affect children. The report shall include any

20 recommendations of the Secretary of Health and Human

21 Services for changes to existing statutory authority, regu-
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1 lations, or agency policy or practice to encourage the in2 vention and development of such devices.

Passed the Senate November 25, 2003.

Attest:

Secretary.
108TH CONGRESS

1ST SESSION S. 1881

AN ACT

To amend the Federal Food, Drug, and Cosmetic

Act to make technical corrections relating to theamendments made by the Medical Device UserFee and Modernization Act of 2002, and forother purposes.