H. R. 3423
One Hundred Ninth Congress
of the
United States of America 
AT THE FIRST SESSION 
Begun and held at the City of Washington on Tuesday, 
the fourth day of January, two thousand and five 
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.
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‘‘(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:
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‘‘(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:
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‘‘(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.’’.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.