S. 1881

One Hundred Eighth Congress

of the

United States of America

AT THE SECOND SESSION

Begun and held at the City of Washington on Tuesday,

the twentieth day of January, two thousand and four

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.

Be it enacted by the Senate and House of Representatives of

the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘Medical Devices Technical Corrections Act’’.

SEC. 2. TECHNICAL CORRECTIONS REGARDING PUBLIC LAW 107–250.

(a) TITLE I; FEES RELATING TO MEDICAL DEVICES.—Part 3

of subchapter C of chapter VII of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 379i et seq.), as added by section 102

of Public Law 107–250 (116 Stat. 1589), is amended—

(1) in section 737—

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

clinical data are generally necessary to provide a reasonable

assurance of safety and effectiveness’’ and inserting ‘‘and

for which substantial clinical data are necessary to provide

a reasonable assurance of safety and effectiveness’’;

(B) in paragraph (4)(D), by striking ‘‘manufacturing,’’;

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

application’’ and all that follows and inserting ‘‘a premarket

application or premarket report under section 515 or a

premarket application under section 351 of the Public

Health Service Act.’’; and

(D) in paragraph (8), by striking ‘‘The term ‘affiliate’

means a business entity that has a relationship with a

second business entity’’ and inserting ‘‘The term ‘affiliate’

means a business entity that has a relationship with a

second business entity (whether domestic or international)’’;

and

(2) in section 738—

(A) in subsection (a)(1)—

(i) in subparagraph (A)—

(I) in the matter preceding clause (i) by

striking ‘‘subsection (d),’’ and inserting ‘‘subsections (d) and (e),’’;

(II) in clause (iv), by striking ‘‘clause (i),’’ and

all that follows and inserting ‘‘clause (i).’’; and
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(III) in clause (vii), by striking ‘‘clause (i),’’

and all that follows and inserting ‘‘clause (i), subject to any adjustment under subsection

(e)(2)(C)(ii).’’; and

(ii) in subparagraph (D), in each of clauses (i)

and (ii), by striking ‘‘application’’ and inserting

‘‘application, report,’’;

(B) in subsection (d)(2)(B), beginning in the second

sentence, by striking ‘‘firms. which show’’ and inserting

‘‘firms, which show’’;

(C) in subsection (e)—

(i) in paragraph (1), by striking ‘‘Where’’ and

inserting ‘‘For fiscal year 2004 and each subsequent

fiscal year, where’’; and

(ii) in paragraph (2)—

(I) in subparagraph (B), beginning in the

second sentence, by striking ‘‘firms. which show’’

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

(II) in subparagraph (C)(i), by striking ‘‘Where’’

and inserting ‘‘For fiscal year 2004 and each subsequent fiscal year, where’’;

(D) in subsection (f), by striking ‘‘for filing’’; and

(E) in subsection (h)(2)(B)—

(i) in clause (ii), by redesignating subclauses (I)

and (II) as items (aa) and (bb), respectively;

(ii) by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively;

(iii) by striking ‘‘The Secretary’’ and inserting the

following: ‘‘(i) IN GENERAL.—The Secretary’’; and

(iv) by adding at the end the following:

‘‘(ii) MORE THAN 5 PERCENT.—To the extent such

costs are more than 5 percent below the specified level

in subparagraph (A)(ii), fees may not be collected under

this section for that fiscal year.’’.

(b) TITLE II; AMENDMENTS REGARDING REGULATION OF MEDICAL

DEVICES.—

(1) INSPECTIONS BY ACCREDITED PERSONS.—Section 704(g)

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)),

as added by section 201 of Public Law 107–250 (116 Stat.

1602), is amended—

(A) in paragraph (1), in the first sentence, by striking

‘‘conducting inspections’’ and all that follows and inserting

‘‘conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II

or class III devices, which inspections are required under

section 510(h) or are inspections of such establishments

required to register under section 510(i).’’;

(B) in paragraph (5)(B), in the first sentence, by

striking ‘‘or poses’’ and all that follows through the period

and inserting ‘‘poses a threat to public health, fails to

act in a manner that is consistent with the purposes of

this subsection, or where the Secretary determines that

there is a financial conflict of interest in the relationship

between the accredited person and the owner or operator

of a device establishment that the accredited person has

inspected under this subsection.’’;
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(C) in paragraph (6)(A)—

(i) in clause (i), by striking ‘‘of the establishment

pursuant to subsection (h) or (i) of section 510’’ and

inserting ‘‘described in paragraph (1)’’;

(ii) in clause (ii)—

(I) in the matter preceding subclause (I)—

(aa) by striking ‘‘each inspection’’ and

inserting ‘‘inspections’’; and

(bb) by inserting ‘‘during a 2-year period’’

after ‘‘person’’; and

(II) in subclause (I), by striking ‘‘such a person’’ and inserting ‘‘an accredited person’’;

(iii) in clause (iii)—

(I) in the matter preceding subclause (I), by

striking ‘‘and the following additional conditions

are met:’’ and inserting ‘‘and 1 or both of the

following additional conditions are met:’’;

(II) in subclause (I), by striking ‘‘accredited’’

and all that follows through the period and

inserting ‘‘(accredited under paragraph (2) and

identified under clause (ii)(II)) as a person authorized to conduct such inspections of device establishments.’’; and

(III) in subclause (II), by inserting ‘‘or by a

person accredited under paragraph (2)’’ after ‘‘by

the Secretary’’;

(iv) in clause (iv)(I)—

(I) in the first sentence— (aa) by striking ‘‘the two immediately preceding inspections of the establishment’’ and

inserting ‘‘inspections of the establishment

during the previous 4 years’’; and

(bb) by inserting ‘‘section’’ after ‘‘pursuant

to’’;

(II) in the third sentence— (aa) by striking ‘‘the petition states a

commercial reason for the waiver;’’; and

(bb) by inserting ‘‘not’’ after ‘‘the Secretary

has not determined that the public health

would’’; and

(III) in the fourth sentence, by striking ‘‘granted until’’ and inserting ‘‘granted or deemed

to be granted until’’; and

(v) in clause (iv)(II)— (I) by inserting ‘‘of a device establishment

required to register’’ after ‘‘to be conducted’’; and

(II) by inserting ‘‘section’’ after ‘‘pursuant to’’;

(D) in paragraph (6)(B)(iii)—

(i) in the first sentence, by striking ‘‘, and data

otherwise describing whether the establishment has

consistently been in compliance with sections 501 and

502 and other’’ and inserting ‘‘and with other’’; and

(ii) in the second sentence—

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

‘‘inspectional findings’’; and

(II) by inserting ‘‘relevant’’ after ‘‘together with

all other’’;
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(E) in paragraph (6)(B)(iv)—

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

(ii) by adding at the end the following:

‘‘(II) If, during the two-year period following clearance under

subparagraph (A), the Secretary determines that the device

establishment is substantially not in compliance with this Act,

the Secretary may, after notice and a written response, notify

the establishment that the eligibility of the establishment for the

inspections by accredited persons has been suspended.’’;

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

with section 510(h), or has not during such period been

inspected pursuant to section 510(i), as applicable’’;

(G) in paragraph (10)(B)(iii), by striking ‘‘a reporting’’

and inserting ‘‘a report’’; and

(H) in paragraph (12)—

(i) by striking subparagraph (A) and inserting the

following:

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

persons pursuant to this subsection and the number of inspections conducted by Federal employees pursuant to section

510(h) and of device establishments required to register under

section 510(i);’’; and

(ii) in subparagraph (E), by striking ‘‘obtained by

the Secretary’’ and all that follows and inserting

‘‘obtained by the Secretary pursuant to inspections conducted by Federal employees;’’.

(2) OTHER CORRECTIONS.—

(A) PROHIBITED ACTS.—Section 301(gg) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C. 331(gg)), as

amended by section 201(d) of Public Law 107–250 (116

Stat. 1609), is amended to read as follows:

‘‘(gg) The knowing failure to comply with paragraph (7)(E)

of section 704(g); the knowing inclusion by a person accredited

under paragraph (2) of such section of false information in an

inspection report under paragraph (7)(A) of such section; or the

knowing failure of such a person to include material facts in such

a report.’’.

(B) ELECTRONIC LABELING.—Section 502(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(f)), as

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

1613), is amended, in the last sentence—

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

and required labeling for in vitro diagnostic devices

intended for use by health care professionals or in

blood establishments’’ after ‘‘in health care facilities’’;

(ii) by inserting a comma after ‘‘means’’;

(iii) by striking ‘‘requirements of law and, that’’

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

(iv) by striking ‘‘the manufacturer affords health

care facilities the opportunity’’ and inserting ‘‘the

manufacturer affords such users the opportunity’’; and

(v) by striking ‘‘the health care facility’’.

(c) TITLE III; ADDITIONAL AMENDMENTS.—

(1) EFFECTIVE DATE.—Section 301(b) of Public Law 107–

250 (116 Stat. 1616), is amended by striking ‘‘18 months’’

and inserting ‘‘36 months’’.
S. 1881—5

(2) PREMARKET NOTIFICATION.—Section 510(o) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added

by section 302(b) of Public Law 107–250 (116 Stat. 1616),

is amended—

(A) in paragraph (1)(B), by striking ‘‘, adulterated’’

and inserting ‘‘or adulterated’’; and

(B) in paragraph (2)—

(i) in subparagraph (B), by striking ‘‘, adulterated’’

and inserting ‘‘or adulterated’’; and

(ii) in subparagraph (E), by striking ‘‘semicritical’’

and inserting ‘‘semi-critical’’.

(d) MISCELLANEOUS CORRECTIONS.—

(1) CERTAIN AMENDMENTS TO SECTION 515.—

(A) IN GENERAL.—

(i) TECHNICAL CORRECTION.—Section 515(c) of the

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

360e(c)), as amended by sections 209 and 302(c)(2)(A)

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

amended by redesignating paragraph (3) (as added

by section 209 of such Public Law) as paragraph (4).

(ii) MODULAR REVIEW.—Section 515(c)(4)(B) of the

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

360e(c)(4)(B)) is amended by striking ‘‘unless an issue

of safety’’ and inserting ‘‘unless a significant issue of

safety’’.

(B) CONFORMING AMENDMENT.—Section 210 of Public

Law 107–250 (116 Stat. 1614) is amended by striking

‘‘, as amended’’ and all that follows through ‘‘by adding’’

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

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

(2) CERTAIN AMENDMENTS TO SECTION 738.—

(A) IN GENERAL.—Section 738(a) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 379j(a)), as amended

by subsection (a), is amended—

(i) in the matter preceding paragraph (1)—

(I) by striking ‘‘(a) TYPES OF FEES.—Beginning

on’’ and inserting the following:

‘‘(a) TYPES OF FEES.—

‘‘(1) IN GENERAL.—Beginning on’’; and

(II) by striking ‘‘this section as follows:’’ and

inserting ‘‘this section.’’; and

(ii) by striking ‘‘(1) PREMARKET APPLICATION,’’ and

inserting the following: ‘‘(2) PREMARKET APPLICATION,’’.

(B) CONFORMING AMENDMENTS.—Section 738 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j),

as amended by subparagraph (A), is amended—

(i) in subsection (d)(1), in the last sentence, by

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

(a)(2)(A)’’;

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

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

(iii) in subsection (e)(2)(C)—

(I) in each of clauses (i) and (ii), by striking

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

(a)(2)(A)(vii)’’; and
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(II) in clause (ii), by striking ‘‘subsection

(a)(1)(A)(i)’’ and inserting ‘‘subsection (a)(2)(A)(i)’’;

and

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

(a)(1)(D),’’ and inserting ‘‘subsection (a)(2)(D),’’.

(C) ADDITIONAL CONFORMING AMENDMENT.—Section

102(b)(1) of Public Law 107–250 (116 Stat. 1600) is

amended, in the matter preceding subparagraph (A), by

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

738(a)(2)(A)(ii)’’.

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

(A) in section 102(a) (116 Stat. 1589), by striking ‘‘(21

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

seq.)’’;

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

(i) by striking paragraph (2);

(ii) in paragraph (1), by redesignating subparagraphs (A) and (B) as paragraphs (1) and (2), respectively; and

(iii) by striking:

‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PREMARKET REPORTS.—

‘‘(1) IN GENERAL.—A person submitting a premarket report’’

and inserting:

‘‘(b) FEE EXEMPTION FOR CERTAIN ENTITIES SUBMITTING PREMARKET REPORTS.—A person submitting a premarket report’’; and

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

‘‘, such as phase IV trials,’’.

SEC. 3. REPORT ON BARRIERS TO AVAILABILITY OF DEVICES

INTENDED FOR CHILDREN.

Not later than 180 days after the date of enactment of this

Act, the Secretary of Health and Human Services shall submit

to the Committee on Health, Education, Labor, and Pensions of

the Senate and the Committee on Energy and Commerce of the

House of Representatives a report on the barriers to the availability

of devices intended for the treatment or diagnosis of diseases and

conditions that affect children. The report shall include any recommendations of the Secretary of Health and Human Services

for changes to existing statutory authority, regulations, or agency
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policy or practice to encourage the invention and development of

such devices.

Speaker of the House of Representatives.

Vice President of the United States and

President of the Senate.