108TH CONGRESS

2D SESSION S. 1881

AMENDMENT

In the House of Representatives, U. S.,

March 10, 2004.

Resolved, That the bill from the Senate (S. 1881) entitled ‘‘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’’, do pass with

the following

AMENDMENT:

Strike out all after the enacting clause and insert:

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 LAW

5 107–250.

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 seq.),

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

10 1589), is amended—

11 (1) in section 737—
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1 (A) in paragraph (4)(B), by striking ‘‘and

2 for which clinical data are generally necessary to

3 provide a reasonable assurance of safety and ef4 fectiveness’’ and inserting ‘‘and for which sub5 stantial clinical data are necessary to provide a

6 reasonable assurance of safety and effectiveness’’;

7 (B) in paragraph (4)(D), by striking ‘‘man8 ufacturing,’’;

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

10 premarket application’’ and all that follows and

11 inserting ‘‘a premarket application or premarket

12 report under section 515 or a premarket applica13 tion under section 351 of the Public Health Serv14 ice Act.’’; and

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

16 term ‘affiliate’ means a business entity that has

17 a relationship with a second business entity’’

18 and inserting ‘‘The term ‘affiliate’ means a busi19 ness entity that has a relationship with a second

20 business entity (whether domestic or inter21 national)’’; and

22 (2) in section 738—

23 (A) in subsection (a)(1)—

24 (i) in subparagraph (A)—
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1 (I) in the matter preceding clause

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

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

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

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

6 inserting ‘‘clause (i).’’; and

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

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

9 inserting ‘‘clause (i), subject to any ad10 justment under subsection

11 (e)(2)(C)(ii).’’; and

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

13 clauses (i) and (ii), by striking ‘‘applica14 tion’’ and inserting ‘‘application, report,’’;

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

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

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

18 (C) in subsection (e)—

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

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

21 2004 and each subsequent fiscal year,

22 where’’; and

23 (ii) in paragraph (2)—

24 (I) in subparagraph (B), begin25 ning in the second sentence, by striking
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1 ‘‘firms. which show’’ and inserting

2 ‘‘firms, which show’’; and

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

4 striking ‘‘Where’’ and inserting ‘‘For

5 fiscal year 2004 and each subsequent

6 fiscal year, where’’;

7 (D) in subsection (f), by striking ‘‘for fil8 ing’’; and

9 (E) in subsection (h)(2)(B)—

10 (i) in clause (ii), by redesignating sub11 clauses (I) and (II) as items (aa) and (bb),

12 respectively;

13 (ii) by redesignating clauses (i) and

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

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

16 inserting the following:

17 ‘‘(i) IN GENERAL.—The Secretary’’;

18 and

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

20 ‘‘(ii) MORE THAN 5 PERCENT.—To the

21 extent such costs are more than 5 percent

22 below the specified level in subparagraph

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

24 section for that fiscal year.’’.
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1 (b) TITLE II; AMENDMENTS REGARDING REGULATION

2 OF MEDICAL DEVICES.—

3 (1) INSPECTIONS BY ACCREDITED PERSONS.—

4 Section 704(g) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 374(g)), as added by section 201

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

7 amended—

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

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

10 follows and inserting ‘‘conducting inspections of

11 establishments that manufacture, prepare, propa12 gate, compound, or process class II or class III

13 devices, which inspections are required under

14 section 510(h) or are inspections of such estab15 lishments required to register under section

16 510(i).’’;

17 (B) in paragraph (5)(B), in the first sen18 tence, by striking ‘‘or poses’’ and all that follows

19 through the period and inserting ‘‘poses a threat

20 to public health, fails to act in a manner that

21 is consistent with the purposes of this subsection,

22 or where the Secretary determines that there is

23 a financial conflict of interest in the relationship

24 between the accredited person and the owner or

25 operator of a device establishment that the ac-
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1 credited person has inspected under this sub2 section.’’;

3 (C) in paragraph (6)(A)—

4 (i) in clause (i), by striking ‘‘of the es5 tablishment pursuant to subsection (h) or

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

7 in paragraph (1)’’;

8 (ii) in clause (ii)—

9 (I) in the matter preceding sub10 clause (I)—

11 (aa) by striking ‘‘each in12 spection’’ and inserting ‘‘inspec13 tions’’; and

14 (bb) by inserting ‘‘during a

15 2-year period’’ after ‘‘person’’;

16 and

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

18 ‘‘such a person’’ and inserting ‘‘an ac19 credited person’’;

20 (iii) in clause (iii)—

21 (I) in the matter preceding sub22 clause (I), by striking ‘‘and the fol23 lowing additional conditions are met:’’

24 and inserting ‘‘and 1 or both of the fol25 lowing additional conditions are met:’’;
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1 (II) in subclause (I), by striking

2 ‘‘accredited’’ and all that follows

3 through the period and inserting ‘‘(ac4 credited under paragraph (2) and

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

6 person authorized to conduct such in7 spections of device establishments.’’;

8 and

9 (III) in subclause (II), by insert10 ing ‘‘or by a person accredited under

11 paragraph (2)’’ after ‘‘by the Sec12 retary’’;

13 (iv) in clause (iv)(I)—

14 (I) in the first sentence—

15 (aa) by striking ‘‘the two im16 mediately preceding inspections of

17 the establishment’’ and inserting

18 ‘‘inspections of the establishment

19 during the previous 4 years’’; and

20 (bb) by inserting ‘‘section’’

21 after ‘‘pursuant to’’;

22 (II) in the third sentence—

23 (aa) by striking ‘‘the petition

24 states a commercial reason for the

25 waiver;’’; and
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1 (bb) by inserting ‘‘not’’ after

2 ‘‘the Secretary has not determined

3 that the public health would’’; and

4 (III) in the fourth sentence, by

5 striking ‘‘granted until’’ and inserting

6 ‘‘granted or deemed to be granted

7 until’’; and

8 (v) in clause (iv)(II)—

9 (I) by inserting ‘‘of a device estab10 lishment required to register’’ after ‘‘to

11 be conducted’’; and

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

13 ‘‘pursuant to’’;

14 (D) in paragraph (6)(B)(iii)—

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

16 and data otherwise describing whether the

17 establishment has consistently been in com18 pliance with sections 501 and 502 and

19 other’’ and inserting ‘‘and with other’’; and

20 (ii) in the second sentence—

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

22 inserting ‘‘inspectional findings’’; and

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

24 ‘‘together with all other’’;

25 (E) in paragraph (6)(B)(iv)—
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1 (i) by inserting ‘‘(I)’’ after ‘‘(iv)’’; and

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

3 ‘‘(II) If, during the two-year period following clear4 ance under subparagraph (A), the Secretary determines

5 that the device establishment is substantially not in compli6 ance with this Act, the Secretary may, after notice and a

7 written response, notify the establishment that the eligi8 bility of the establishment for the inspections by accredited

9 persons has been suspended.’’;

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

11 accordance with section 510(h), or has not dur12 ing such period been inspected pursuant to sec13 tion 510(i), as applicable’’;

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

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

16 (H) in paragraph (12)—

17 (i) by striking subparagraph (A) and

18 inserting the following:

19 ‘‘(A) the number of inspections conducted by ac20 credited persons pursuant to this subsection and the

21 number of inspections conducted by Federal employees

22 pursuant to section 510(h) and of device establish23 ments required to register under section 510(i);’’; and

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

25 ‘‘obtained by the Secretary’’ and all that
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1 follows and inserting ‘‘obtained by the Sec2 retary pursuant to inspections conducted by

3 Federal employees;’’.

4 (2) OTHER CORRECTIONS.—

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

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

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

8 Public Law 107–250 (116 Stat. 1609), is amend9 ed to read as follows:

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

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

12 accredited under paragraph (2) of such section of false in13 formation in an inspection report under paragraph (7)(A)

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

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

16 (B) ELECTRONIC LABELING.—Section

17 502(f) of the Federal Food, Drug, and Cosmetic

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

19 206 of Public Law 107–250 (116 Stat. 1613), is

20 amended, in the last sentence—

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

22 professional and required labeling for in

23 vitro diagnostic devices intended for use by

24 health care professionals or in blood estab25 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 Public

14 Law 107–250 (116 Stat. 1616), is amended by strik15 ing ‘‘18 months’’ and inserting ‘‘36 months’’.

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

17 of the Federal Food, Drug, and Cosmetic Act (21

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

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

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

21 adulterated’’ and inserting ‘‘or adulterated’’; and

22 (B) in paragraph (2)—

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

24 adulterated’’ and inserting ‘‘or adulter25 ated’’; and
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1 (ii) in subparagraph (E), by striking

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

3 (d) MISCELLANEOUS CORRECTIONS.—

4 (1) CERTAIN AMENDMENTS TO SECTION 515.—

5 (A) IN GENERAL.—

6 (i) TECHNICAL CORRECTION.—Section

7 515(c) of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 360e(c)), as amended

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

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

11 amended by redesignating paragraph (3)

12 (as added by section 209 of such Public

13 Law) as paragraph (4).

14 (ii) MODULAR REVIEW.—Section

15 515(c)(4)(B) of the Federal Food, Drug, and

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

17 amended by striking ‘‘unless an issue of

18 safety’’ and inserting ‘‘unless a significant

19 issue of safety’’.

20 (B) CONFORMING AMENDMENT.—Section

21 210 of Public Law 107–250 (116 Stat. 1614) is

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

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

24 amended in paragraph (3), as redesignated by

25 section 302(c)(2)(A) of this Act, by adding’’.
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1 (2) CERTAIN AMENDMENTS TO SECTION 738.—

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

3 Federal Food, Drug, and Cosmetic Act (21

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

5 amended—

6 (i) in the matter preceding paragraph

7 (1)—

8 (I) by striking ‘‘(a) TYPES OF

9 FEES.—Beginning on’’ and inserting

10 the following:

11 ‘‘(a) TYPES OF FEES.—

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

13 (II) by striking ‘‘this section as

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

15 and

16 (ii) by striking ‘‘(1) PREMARKET AP17 PLICATION,’’ and inserting the following:

18 ‘‘(2) PREMARKET APPLICATION,’’.

19 (B) CONFORMING AMENDMENTS.—Section

20 738 of the Federal Food, Drug, and Cosmetic Act

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

22 (A), is amended—

23 (i) in subsection (d)(1), in the last sen24 tence, by striking ‘‘subsection (a)(1)(A)’’

25 and inserting ‘‘subsection (a)(2)(A)’’;
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1 (ii) in subsection (e)(1), by striking

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

3 ‘‘subsection (a)(2)(A)(vii)’’;

4 (iii) in subsection (e)(2)(C)—

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

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

7 and inserting ‘‘subsection

8 (a)(2)(A)(vii)’’; and

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

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

11 ‘‘subsection (a)(2)(A)(i)’’; and

12 (iv) in subsection (j), by striking ‘‘sub13 section (a)(1)(D),’’ and inserting ‘‘sub14 section (a)(2)(D),’’.

15 (C) ADDITIONAL CONFORMING AMEND16 MENT.—Section 102(b)(1) of Public Law 107–

17 250 (116 Stat. 1600) is amended, in the matter

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

19 738(a)(1)(A)(ii)’’ and inserting ‘‘section

20 738(a)(2)(A)(ii)’’.

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

22 is amended—

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

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

25 ‘‘(21 U.S.C. 379f et seq.)’’;
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1 (B) in section 102(b) (116 Stat. 1600)—

2 (i) by striking paragraph (2);

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

4 subparagraphs (A) and (B) as paragraphs

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

6 (iii) by striking:

7 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB8 MITTING PREMARKET REPORTS.—

9 ‘‘(1) IN GENERAL.—A person submitting a pre10 market report’’and inserting:

11 ‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUB12 MITTING PREMARKET REPORTS.—A person submitting a

13 premarket report’’; and

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

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

16 SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DE17 VICES INTENDED FOR CHILDREN.

18 Not later than 180 days after the date of enactment

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

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

21 and Pensions of the Senate and the Committee on Energy

22 and Commerce of the House of Representatives a report on

23 the barriers to the availability of devices intended for the

24 treatment or diagnosis of diseases and conditions that affect

25 children. The report shall include any recommendations of
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1 the Secretary of Health and Human Services for changes

2 to existing statutory authority, regulations, or agency pol3 icy or practice to encourage the invention and development

4 of such devices.

Attest:

Clerk.