108TH CONGRESS

2D SESSION H. R. 3493

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,
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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
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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)(B)—

21 (i) in clause (ii), by redesignating sub22 clauses (I) and (II) as items (aa) and (bb),

23 respectively;

24 (ii) by redesignating clauses (i) and

25 (ii) as subclauses (I) and (II), respectively;
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1 (iii) by striking ‘‘The Secretary’’ and

2 inserting the following:

3 ‘‘(i) IN GENERAL.—The Secretary’’;

4 and

5 (iv) by adding at the end the fol6 lowing:

7 ‘‘(ii) MORE THAN 5 PERCENT.—To

8 the extent such costs are more than 5 per9 cent below the specified level in subpara10 graph (A)(ii), fees may not be collected

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

12 (b) TITLE II; AMENDMENTS REGARDING REGULA13 TION OF MEDICAL DEVICES.—

14 (1) INSPECTIONS BY ACCREDITED PERSONS.—

15 Section 704(g) of the Federal Food, Drug, and Cos16 metic Act (21 U.S.C. 374(g)), as added by section

17 201 of Public Law 107–250 (116 Stat. 1602), is

18 amended—

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

20 by striking ‘‘conducting inspections’’ and all

21 that follows and inserting ‘‘conducting inspec22 tions of establishments that manufacture, pre23 pare, propagate, compound, or process class II

24 or class III devices, which inspections are re25 quired under section 510(h) or are inspections
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1 of such establishments required to register

2 under section 510(i).’’;

3 (B) in paragraph (5)(B), in the first sen4 tence, by inserting after ‘‘standards of accredi5 tation,’’ the following: ‘‘or where the Secretary

6 has information indicating that the relationship

7 between the establishment and the accredited

8 person may create a conflict of interest,’’;

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 ‘‘de13 scribed 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

6 following additional conditions are

7 met:’’;

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

9 ‘‘identified under subclause (II) of

10 this clause’’ and inserting ‘‘identified

11 under clause (ii)(II) as a person au12 thorized to conduct inspections of de13 vice establishments’’; and

14 (III) in subclause (II), by insert15 ing ‘‘or by a person accredited under

16 paragraph (2)’’ after ‘‘by the Sec17 retary’’;

18 (iv) in clause (iv)(I)—

19 (I) in the first sentence—

20 (aa) by striking ‘‘the two

21 immediately preceding inspec22 tions of the establishment’’ and

23 inserting ‘‘inspections of the es24 tablishment during the previous

25 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 peti5 tion states a commercial reason

6 for the waiver;’’; and

7 (bb) by inserting ‘‘not’’ after

8 ‘‘the Secretary has not deter9 mined that the public health

10 would’’; and

11 (III) in the fourth sentence, by

12 striking ‘‘granted until’’ and inserting

13 ‘‘granted or deemed to be granted

14 until’’;

15 (v) in clause (iv)(II)—

16 (I) by inserting ‘‘of a device es17 tablishment required to register’’ after

18 ‘‘to be conducted’’; and

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

20 ‘‘pursuant to’’; and

21 (vi) by adding at the end the following

22 clause:

23 ‘‘(v) The eligibility of the establishment for in24 spections by accredited persons has not been sus25 pended under subparagraph (B)(iv)(II).’’;
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1 (D) in paragraph (6)(B)(iii)—

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

3 and data otherwise describing whether the

4 establishment has consistently been in

5 compliance with sections 501 and 502’’;

6 (ii) in the second sentence—

7 (I) by striking ‘‘inspections’’ and

8 inserting ‘‘inspectional findings’’; and

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

10 ‘‘together with all other’’; and

11 (iii)(I) by inserting ‘‘(I)’’ after ‘‘(iii)’’;

12 (II) by adding at the end the fol13 lowing subclause:

14 ‘‘(II) In making a decision under this paragraph, the

15 Secretary may consider any information relevant to the

16 establishment’s compliance with any provision of this Act.

17 Nothing in the preceding sentence shall be construed to

18 expand the Secretary’s inspectional authority under sub19 section (a).’’;

20 (E) in paragraph (6)(B)(iv)—

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

22 (ii) by adding at the end the following

23 subclause:

24 ‘‘(II) If, during the two-year period following clear25 ance under subparagraph (A) with respect to a device es-
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1 tablishment, the Secretary obtains information indicating

2 significant deviations from compliance with this Act or im3 plementing regulations, the Secretary may, after notice

4 and an opportunity for a written response, notify the es5 tablishment that the eligibility of the establishment for in6 spections by accredited person has been suspended.’’;

7 (F) in paragraph (6)(C)(ii), by striking ‘‘in

8 accordance with section 510(h), or has not dur9 ing such period been inspected pursuant to sec10 tion 510(i), as applicable’’;

11 (G) in paragraph (10)(B)(iii), by striking

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

13 (H) in paragraph (12)—

14 (i) by striking subparagraph (A) and

15 inserting the following:

16 ‘‘(A) the number of inspections conducted

17 by accredited persons pursuant to this sub18 section and the number of inspections con19 ducted by Federal employees pursuant to sec20 tion 510(h) and of device establishments re21 quired to register under section 510(i);’’; and

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

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

24 follows and inserting ‘‘obtained by the Sec-
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1 retary pursuant to inspections conducted

2 by Federal employees;’’.

3 (2) OTHER CORRECTIONS.—

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

5 of the Federal Food, Drug, and Cosmetic Act

6 (21 U.S.C. 331(gg)), as amended by section

7 201(d) of Public Law 107–250 (116 Stat.

8 1609), is amended to read as follows:

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

10 (7)(E) of section 704(g); the knowing inclusion by a per11 son accredited under paragraph (2) of such section of false

12 information in an inspection report under paragraph

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

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

15 (B) ELECTRONIC LABELING.—Section

16 502(f) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 352(f)), as amended by

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

19 1613), is amended, in the last sentence—

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

21 professional and required labeling for in

22 vitro diagnostic devices intended for use by

23 health care professionals or in blood estab24 lishments’’ after ‘‘in health care facilities’’;
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1 (ii) by inserting a comma after

2 ‘‘means’’;

3 (iii) by striking ‘‘requirements of law

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

5 law, and that’’;

6 (iv) by striking ‘‘the manufacturer af7 fords health care facilities the opportunity’’

8 and inserting ‘‘the manufacturer affords

9 such users the opportunity’’; and

10 (v) by striking ‘‘the health care facil11 ity’’.

12 (c) TITLE III; ADDITIONAL AMENDMENTS.—

13 (1) EFFECTIVE DATE.—Section 301(b) of Pub14 lic Law 107–250 (116 Stat. 1616), is amended by

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

16 (2) PREMARKET NOTIFICATION.—Section

17 510(o) of the Federal Food, Drug, and Cosmetic Act

18 (21 U.S.C. 360(o)), as added by section 302(b) of

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

20 amended—

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

22 adulterated’’ and inserting ‘‘or adulterated’’;

23 and

24 (B) in paragraph (2)—
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1 (i) in subparagraph (B), by striking ‘‘,

2 adulterated’’ and inserting ‘‘or adulter3 ated’’; and

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

5 ‘‘semicritical’’ and inserting ‘‘semi-crit6 ical’’.

7 (d) MISCELLANEOUS CORRECTIONS.—

8 (1) CERTAIN AMENDMENTS TO SECTION 515.—

9 (A) IN GENERAL.—

10 (i) TECHNICAL CORRECTION.—Section

11 515(c) of the Federal Food, Drug, and

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

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

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

15 1618), is amended by redesignating para16 graph (3) (as added by section 209 of such

17 Public Law) as paragraph (4).

18 (ii) MODULAR REVIEW.—Section

19 515(c)(4)(B) of the Federal Food, Drug,

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

21 360e(c)(4)(B)) is amended by striking

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

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

24 (B) CONFORMING AMENDMENT.—Section

25 210 of Public Law 107–250 (116 Stat. 1614)
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1 is amended by striking ‘‘, as amended’’ and all

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

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

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

5 (2) CERTAIN AMENDMENTS TO SECTION 738.—

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

7 Federal Food, Drug, and Cosmetic Act (21

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

9 is amended—

10 (i) in the matter preceding paragraph

11 (1)—

12 (I) by striking ‘‘(a) TYPES OF

13 FEES.—Beginning on’’ and inserting

14 the following:

15 ‘‘(a) TYPES OF FEES.—

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

17 (II) by striking ‘‘this section as

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

19 and

20 (ii) by striking ‘‘(1) PREMARKET AP21 PLICATION,’’ and inserting the following:

22 ‘‘(2) PREMARKET APPLICATION,’’.

23 (B) CONFORMING AMENDMENTS.—Section

24 738 of the Federal Food, Drug, and Cosmetic
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1 Act (21 U.S.C. 379j), as amended by subpara2 graph (A), is amended—

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

4 sentence, by striking ‘‘subsection

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

6 (a)(2)(A)’’;

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

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

9 ‘‘subsection (a)(2)(A)(vii)’’;

10 (iii) in subsection (e)(2)(C)—

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

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

13 and inserting ‘‘subsection

14 (a)(2)(A)(vii)’’; and

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

16 ‘‘subsection (a)(1)(A)(i)’’ and insert17 ing ‘‘subsection (a)(2)(A)(i)’’; and

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

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

20 ‘‘subsection (a)(2)(D),’’.

21 (C) ADDITIONAL CONFORMING AMEND22 MENT.—Section 102(b)(1) of Public Law 107–

23 250 (116 Stat. 1600) is amended, in the matter

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

2 738(a)(2)(A)(ii)’’.

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

4 250 is amended—

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

6 striking ‘‘(21 U.S.C. 379F et seq.)’’ and insert7 ing ‘‘(21 U.S.C. 379f et seq.)’’;

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

9 (i) by striking paragraph (2);

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

11 subparagraphs (A) and (B) as paragraphs

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

13 (iii) by striking:

14 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB15 MITTING PREMARKET REPORTS.—

16 ‘‘(1) IN GENERAL.—A person submitting a pre17 market report’’ and inserting:

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

20 premarket report’’; and

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

22 by striking ‘‘, such as phase IV trials,’’.
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1 SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DE2 VICES INTENDED FOR CHILDREN.

3 Not later than 180 days after the date of enactment

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

5 shall submit to the Committee on Health, Education,

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

7 Energy and Commerce of the House of Representatives

8 a report on the barriers to the availability of devices in9 tended for the treatment or diagnosis of diseases and con10 ditions that affect children. The report shall include any

11 recommendations of the Secretary of Health and Human

12 Services for changes to existing statutory authority, regu13 lations, or agency policy or practice to encourage the in14 vention and development of such devices.

Passed the House of Representatives January 27,

2004.

Attest:

Clerk.

108TH CONGRESS

2D SESSION H. R. 3493

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.