[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 1881 Referred in House (RFH)]
1st Session
S. 1881
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 8, 2003
Referred to the Committee on Energy and Commerce
_______________________________________________________________________
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 (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
``under subclause (II) of this clause''
and inserting ``under clause
(ii)(II)''; 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'';
(C) 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
(ii) in the second sentence--
(I) by striking ``inspections'' and
inserting ``inspectional findings'';
and
(II) by inserting ``relevant''
after ``together with all other'';
(D) 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'';
(E) in paragraph (10)(B)(iii), by striking ``a
reporting'' and inserting ``a report''; and
(F) 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.
Passed the Senate November 25, 2003.
Attest:
EMILY J. REYNOLDS,
Secretary.