109TH CONGRESS 
1ST SESSION 
H. R. 3423
AN ACT 
To amend the Federal Food, Drug, and Cosmetic 
Act with respect to medical device user fees.
109TH CONGRESS 
1ST SESSION H. R. 3423
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 Representa-
tives 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 amend-
ed—
(1) in subsection (b)—
(A) after ‘‘2004;’’, by inserting ‘‘and’’; and 
(B) by striking ‘‘2005;’’ and all that fol-
lows 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 sub-
section (a). The fees’’; 
(iii) striking ‘‘2003’’ and inserting 
‘‘2006’’; and 
(iv) striking ‘‘$154,000.’’ and insert-
ing ‘‘$259,600, and the fees established for 
fiscal year 2007 shall be based on a pre-
market 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 pre-
vious 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. 
‘‘(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 Com-
mittee 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 Appropria-
tions of the House of Representatives.’’; 
(3) in subsection (d)—
(A) in paragraph (1), by inserting after 
the first sentence the following: ‘‘For the pur-
poses of this paragraph, the term ‘small busi-
ness’ 
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 insert-
ing ‘‘paragraph,’’; 
(iii) striking ‘‘$30,000,000’’ and in-
serting ‘‘$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 Sec-
retary is expected to meet all of the per-
formance goals identified for the fiscal year 
if the amount so appropriated for such fis-
cal year, excluding the amount of fees ap-
propriated 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 mat-
ter 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 appro-
priated for such fiscal year, is more than 
1 percent less than the amount that ap-
plies under clause (i), the following ap-
plies:’’; 
(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 per-
cent’’ 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: 
‘‘(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 applica-
tion or notification, from businesses with gross re-
ceipts 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 perform-
ance 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 Fed-
eral 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 reproc-
essed single-use device, unless it, or an attachment there-
to, prominently and conspicuously bears the name of the 
manufacturer of the reprocessed device, a generally recog-
nized 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 recog-
nized abbreviation of such name, or a unique and generally 
recognized symbol identifying such manufacturer, a re-
processed device may satisfy the requirements of para-
graph (1) through the use of a detachable label on the 
packaging that identifies the manufacturer and is in-
tended 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 rec-
ognized abbreviation of such name, or a unique and 
generally recognized symbol identifying such manu-
facturer, 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 Med-
ical 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: 
‘‘(b) EFFECTIVE DATE.—Section 502(u) of the Fed-
eral Food, Drug, and Cosmetic Act (as amended by sec-
tion 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 De-
vice User Fee Stabilization Act of 2005, or the 
date on which the original device first bears the 
name of the manufacturer of the original de-
vice, a generally recognized abbreviation of such 
name, or a unique and generally recognized 
symbol identifying such manufacturer, which-
ever 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.’’.
Passed the House of Representatives July 26, 2005. 
Attest:
Clerk.