Medical Device User Fee Stabilization Act of 2005
PL 109-43 (H.R.3423), enacted 08/01/2005

119 STAT. 439
PUBLIC LAW 109–43—AUG. 1, 2005
Public Law 109–43
109th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to medical
device user fees.
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 Device User Fee Sta-
bilization Act of 2005’’.
SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT.
(a) DEVICE USER FEES.—Section 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j) is amended—
(1) in subsection (b)—
(A) after ‘‘2004;’’, by inserting ‘‘and’’; and
(B) by striking ‘‘2005;’’ and all that follows through
‘‘2007’’ and inserting ‘‘2005’’;
(2) in subsection (c)—
(A) by striking the heading and inserting ‘‘Annual Fee
Setting.—’’;
(B) by striking paragraphs (1), (2), (3), and (4);
(C) by redesignating paragraphs (5) and (6) as para-
graphs (1) and (2), respectively;
(D) in paragraph (1), as so redesignated, by—
(i) striking the heading and inserting ‘‘IN GEN-
ERAL.—’’;
(ii) striking ‘‘establish, for the next fiscal year,
and’’ and all that follows through ‘‘the fees’’ and
inserting ‘‘publish in the Federal Register fees under
subsection (a). The fees’’;
(iii) striking ‘‘2003’’ and inserting ‘‘2006’’; and
(iv) striking ‘‘$154,000.’’ and inserting ‘‘$259,600,
and the fees established for fiscal year 2007 shall be
based on a premarket application fee of $281,600.’’;
and
(E) by adding at the end the following:
‘‘(3) SUPPLEMENT.—
‘‘(A) IN
GENERAL.—For fiscal years 2006 and 2007,
the Secretary may use unobligated carryover balances from
fees collected in previous fiscal years to ensure that suffi-
cient fee revenues are available in that fiscal year, so
long as the Secretary maintains unobligated carryover bal-
ances of not less than 1 month of operating reserves for
the first month of fiscal year 2008.
21 USC 301 note.
Aug. 1, 2005
[H.R. 3423]
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119 STAT. 440
PUBLIC LAW 109–43—AUG. 1, 2005
‘‘(B) NOTICE TO CONGRESS.—Not later than 14 days
before the Secretary anticipates the use of funds described
in subparagraph (A), the Secretary shall provide notice
to the Committee on Health, Education, Labor, and Pen-
sions and the Committee on Appropriations of the Senate
and the Committee on Energy and Commerce and the
Committee on Appropriations of the House of Representa-
tives.’’;
(3) in subsection (d)—
(A) in paragraph (1), by inserting after the first sen-
tence the following: ‘‘For the purposes of this paragraph,
the term ‘small business’ means an entity that reported
$30,000,000 or less of gross receipts or sales in its most
recent Federal income tax return for a taxable year,
including such returns of all of its affiliates, partners,
and parent firms.’’; and
(B) in paragraph (2)(A), by—
(i) striking ‘‘(i) IN GENERAL.—’’;
(ii) striking ‘‘subsection,’’ and inserting ‘‘para-
graph,’’;
(iii) 
striking 
‘‘$30,000,000’’ 
and 
inserting
‘‘$100,000,000’’; and
(iv) striking clause (ii);
(4) in subsection (e)(2)(A), by striking ‘‘$30,000,000’’ and
inserting ‘‘$100,000,000’’;
(5) in subsection (g)(1)—
(A) in subparagraph (B)—
(i) by striking clause (i) and inserting the following:
‘‘(i) For fiscal year 2005, the Secretary is expected
to meet all of the performance goals identified for
the fiscal year if the amount so appropriated for such
fiscal year, excluding the amount of fees appropriated
for such fiscal year, is equal to or greater than
$205,720,000 multiplied by the adjustment factor
applicable to the fiscal year.’’; and
(ii) in clause (ii), by striking the matter preceding
subclause (I) and inserting the following:
‘‘(ii) For fiscal year 2005, if the amount so appro-
priated for such fiscal year, excluding the amount of
fees appropriated for such fiscal year, is more than
1 percent less than the amount that applies under
clause (i), the following applies:’’;
(B) in subparagraph (C)—
(i) in the matter preceding clause (i), by—
(I) striking ‘‘2003 through’’ and inserting ‘‘2005
and’’; and
(II) inserting ‘‘more than 1 percent’’ after
‘‘years, is’’; and
(ii) in clause (ii), by striking ‘‘sum’’ and inserting
‘‘amount’’; and
(C) in subparagraph (D)(i), by inserting ‘‘more than
1 percent’’ after ‘‘year, is’’;
(6) in subsection (h)(3)—
(A) in subparagraph (C), by striking the semicolon
and inserting ‘‘; and’’; and
(B) by striking subparagraphs (D) and (E) and inserting
the following:
Deadline.
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119 STAT. 441
PUBLIC LAW 109–43—AUG. 1, 2005
‘‘(D) such sums as may be necessary for each of fiscal
years 2006 and 2007.’’; and
(7) by striking ‘‘subsection (c)(5)’’ each place it appears
and inserting ‘‘subsection (c)(1)’’.
(b) ANNUAL REPORTS.—Section 103 of the Medical Device User
Fee and Modernization Act of 2002 (Public Law 107–250 (116
Stat. 1600)) is amended—
(1) by striking ‘‘Beginning with’’ and inserting ‘‘(a) IN GEN-
ERAL.—Beginning with’’; and
(2) by adding at the end the following:
‘‘(b) ADDITIONAL INFORMATION.—For fiscal years 2006 and 2007,
the report described under subsection (a)(2) shall include—
‘‘(1) information on the number of different types of applica-
tions and notifications, and the total amount of fees paid for
each such type of application or notification, from businesses
with gross receipts or sales from $0 to $100,000,000, with
such businesses categorized in $10,000,000 intervals; and
‘‘(2) a certification by the Secretary that the amounts appro-
priated for salaries and expenses of the Food and Drug Adminis-
tration for such fiscal year and obligated by the Secretary
for the performance of any function relating to devices that
is not for the process for the review of device applications,
as defined in paragraph (5) of section 737 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379i), are not less than
such amounts for fiscal year 2002 multiplied by the adjustment
factor, as defined in paragraph (7) of such section 737.’’.
(c) MISBRANDED DEVICES.—
(1) IN GENERAL.—Section 502(u) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 352(u)) is amended to read as
follows:
‘‘(u)(1) Subject to paragraph (2), if it is a reprocessed single-
use device, unless it, or an attachment thereto, prominently and
conspicuously bears the name of the manufacturer of the
reprocessed device, a generally recognized abbreviation of such
name, or a unique and generally recognized symbol identifying
such manufacturer.
‘‘(2) If the original device or an attachment thereto does not
prominently and conspicuously bear the name of the manufacturer
of the original device, a generally recognized abbreviation of such
name, or a unique and generally recognized symbol identifying
such manufacturer, a reprocessed device may satisfy the require-
ments of paragraph (1) through the use of a detachable label on
the packaging that identifies the manufacturer and is intended
to be affixed to the medical record of a patient.’’.
(2) GUIDANCE.—Not later than 180 days after the date
of enactment of this Act, the Secretary of Health and Human
Services shall issue guidance to identify circumstances in which
the name of the manufacturer of the original device, a generally
recognized abbreviation of such name, or a unique and generally
recognized symbol identifying such manufacturer, is not ‘‘promi-
nent and conspicuous’’, as used in section 502(u) of Federal
Food, Drug, and Cosmetic Act (as amended by paragraph (1)).
(d) EFFECTIVE DATE.—Section 301(b) of the Medical Device
User Fee and Modernization Act of 2002 (Public Law 107–250
(116 Stat. 1616)), as amended by section 2(c) of Public Law 108–
214 (118 Stat. 575), is amended to read as follows:
21 USC 352 note.
Deadline.
21 USC 352 note.
Labeling.
Certification.
21 USC 379i
note.
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119 STAT. 442
PUBLIC LAW 109–43—AUG. 1, 2005
LEGISLATIVE HISTORY—H.R. 3423 (S. 1420):
SENATE REPORTS: No. 109–107 accompanying S. 1420 (Comm. on Health, Edu-
cation, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 151 (2005):
July 26, considered and passed House.
July 27, considered and passed Senate.
‘‘(b) EFFECTIVE DATE.—Section 502(u) of the Federal Food,
Drug, and Cosmetic Act (as amended by section 2(c) of the Medical
Device User Fee Stabilization Act of 2005)—
‘‘(1) shall be effective—
‘‘(A) with respect to devices described under paragraph
(1) of such section, 12 months after the date of enactment
of the Medical Device User Fee Stabilization Act of 2005,
or the date on which the original device first bears the
name of the manufacturer of the original device, a generally
recognized abbreviation of such name, or a unique and
generally recognized symbol identifying such manufacturer,
whichever is later; and
‘‘(B) with respect to devices described under paragraph
(2) of such section 502(u), 12 months after such date of
enactment; and
‘‘(2) shall apply only to devices reprocessed and introduced
or delivered for introduction in interstate commerce after such
applicable effective date.’’.
Approved August 1, 2005.
Applicability.
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