[United States Statutes at Large, Volume 118, 108th Congress, 2nd Session]
[From the U.S. Government Printing Office, www.gpo.gov]

118 STAT. 572

Public Law 108-214
108th Congress

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. NOTE: Apr.
1, 2004 -  [S. 1881]

Be it enacted by the Senate and House of Representatives of the
United States of NOTE: Medical Devices Technical Corrections
Act. America in Congress assembled,

SECTION 1. NOTE: 21 USC 301 note. 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 NOTE: 21 USC 379i. 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 NOTE: 21 USC 379j. 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

[[Page 573]]
118 STAT. 573

(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.'';

[[Page 574]]
118 STAT. 574

(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'';

[[Page 575]]
118 STAT. 575

(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), NOTE: 21 USC 352 note. is amended by
striking ``18 months'' and inserting ``36 months''.

[[Page 576]]
118 STAT. 576

(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) NOTE: 21 USC 360e. 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

[[Page 577]]
118 STAT. 577

(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) NOTE: 21 USC 379j note. 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), NOTE: 21
USC 379i, 379j. 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), NOTE: 21 USC 360l note. by striking ``, such
as phase IV trials,''.
SEC. 3. REPORT NOTE: Deadline. 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

[[Page 578]]
118 STAT. 578

policy or practice to encourage the invention and development of such
devices.

Approved April 1, 2004.

LEGISLATIVE HISTORY--S. 1881 (H.R. 3493):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 108-433 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD:
Vol. 149 (2003):
Nov. 25, considered and passed
Senate.
Vol. 150 (2004):
Mar. 9, 10, considered and passed
House, amended.
Mar. 12, Senate concurred in House
amendment.