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 Stabilization 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 paragraphs (1) and (2), respectively; 

(D) in paragraph (1), as so redesignated, by—

(i) striking the heading and inserting ‘‘IN GENERAL.—’’; 

(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 sufficient fee revenues are available in that fiscal year, so 

long as the Secretary maintains unobligated carryover balances of not less than 1 month of operating reserves for 

the first month of fiscal year 2008. 
H. R. 3423—2

‘‘(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 Pensions and the Committee on Appropriations of the Senate 

and the Committee on Energy and Commerce and the 

Committee on Appropriations of the House of Representatives.’’; 

(3) in subsection (d)—

(A) in paragraph (1), by inserting after the first sentence 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 ‘‘paragraph,’’; (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 appropriated 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: 
H. R. 3423—3

‘‘(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 GENERAL.—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 applications 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 appropriated for salaries and expenses of the Food and Drug Administration 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 singleuse 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 requirements 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 ‘‘prominent 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: 
H. R. 3423—4

‘‘(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.