[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1881 Enrolled Bill (ENR)]
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
(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.'';
(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'';
(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''.
(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
(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 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.