II 

109TH CONGRESS 

1ST SESSION S. 1420 

To amend the Federal Food, Drug, and Cosmetic Act with respect to medical 

device user fees. 

IN THE SENATE OF THE UNITED STATES 

JULY 18, 2005 

Mr. ENZI (for himself, Mr. KENNEDY, Mr. BURR, Mr. DEWINE, Ms. MIKULSKI, Mr. DODD, and Mrs. MURRAY) introduced the following bill; which 

was read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

A BILL

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to medical device user fees.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Device User 

5 Fee Stabilization Act of 2005’’. 
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1 SEC. 2. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

2 COSMETIC ACT. 

3 (a) DEVICE USER FEES.—Section 738 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amend5 ed— 

6 (1) in subsection (b)— 

7 (A) after ‘‘2004;’’, by inserting ‘‘and’’; and 

8 (B) by striking ‘‘2005;’’ and all that fol9 lows through ‘‘2007’’ and inserting ‘‘2005’’; 

10 (2) in subsection (c)— 

11 (A) by striking paragraphs (1), (2), and 

12 (3); 

13 (B) by redesignating paragraphs (4), (5), 

14 and (6) as paragraphs (1), (2), and (3), respec15 tively; 

16 (C) in paragraph (1), as so redesignated, 

17 by— 

18 (i) striking the paragraph heading 

19 and inserting ‘‘2007 INCREASE’’; 

20 (ii) striking ‘‘, in addition to adjust21 ments under paragraphs (1) and (2), fur22 ther’’; 

23 (iii) striking ‘‘established in sub24 section (b)’’ and inserting ‘‘under sub25 section (a)’’; and 
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1 (iv) striking ‘‘adjustment’’ each place 

2 it appears and inserting ‘‘increase’’; and 

3 (D) in paragraph (2), as so redesignated, 

4 by— 

5 (i) striking ‘‘establish, for the next fis6 cal year, and’’ and all that follows through 

7 ‘‘the fees’’ and inserting ‘‘publish in the 

8 Federal Register fees under subsection (a). 

9 The fees’’; 

10 (ii) striking ‘‘2003’’ and inserting 

11 ‘‘2006’’; and 

12 (iii) striking ‘‘$154,000.’’ and insert13 ing ‘‘$259,600, and the fees established for 

14 fiscal year 2007 shall be based on a pre15 market application fee of $281,600.’’; 

16 (3) in subsection (d)(2)(A)— 

17 (A) in clause (i), by striking 

18 ‘‘$30,000,000’’ and inserting ‘‘$75,000,000’’; 

19 and 

20 (B) by striking clause (ii) and inserting the 

21 following: 

22 ‘‘(ii) ADJUSTMENTS.— 

23 ‘‘(I) IN GENERAL.—If the Sec24 retary has evidence from actual expe25 rience that the $75,000,000 threshold 
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1 established in clause (i) results in a 

2 reduction in revenues from premarket 

3 applications, premarket reports, and 

4 supplements that is 26 percent or 

5 more than would occur without small 

6 business exemptions and lower fee 

7 rates, the Secretary may— 

8 ‘‘(aa) use the operating re9 serves in an amount not to ex10 ceed the lesser of— 

11 ‘‘(AA) 10 percent of the 

12 fees collected in fiscal year 

13 2005; or 

14 ‘‘(BB) $2,500,000; and 

15 ‘‘(bb) upon the exhaustion of 

16 the amount described under item 

17 (aa), adjust the $75,000,000 

18 threshold as provided for under 

19 subclause (II). 

20 ‘‘(II) ADJUSTMENT OF THRESH21 OLD.—To adjust the threshold de22 scribed in subclause (I)(bb), the Sec23 retary shall publish a notice in the 

24 Federal Register setting out the ra25 tionale for the adjustment, and the 
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1 new threshold. Such adjusted thresh2 old may not be less than $30,000,000 

3 and may not be retroactive.’’; 

4 (4) in subsection (e)(2)(A), by striking 

5 ‘‘$30,000,000’’ and inserting ‘‘$75,000,000’’; 

6 (5) in subsection (g)(1)— 

7 (A) in subparagraph (B)— 

8 (i) by striking clause (i) and inserting 

9 the following: 

10 ‘‘(i) For fiscal year 2005, the Sec11 retary is expected to meet all of the per12 formance goals identified for the fiscal year 

13 if the amount so appropriated for such fis14 cal year, excluding the amount of fees ap15 propriated for such fiscal year, is equal to 

16 or greater than $205,720,000 multiplied 

17 by the adjustment factor applicable to the 

18 fiscal year.’’; and 

19 (ii) in clause (ii), by striking the mat20 ter preceding subclause (I) and inserting 

21 the following: 

22 ‘‘(ii) For fiscal year 2005, if the 

23 amount so appropriated for such fiscal 

24 year, excluding the amount of fees appro25 priated for such fiscal year, is more than 
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1 1 percent less than the amount that ap2 plies under clause (i), the following ap3 plies:’’; and 

4 (B) in subparagraph (C)— 

5 (i) in the matter preceding clause (i), 

6 by— 

7 (I) striking ‘‘2003 through’’ and 

8 inserting ‘‘2005 and’’; and 

9 (II) inserting ‘‘more than 1 per10 cent’’ after ‘‘years, is’’; and 

11 (ii) in clause (ii), by striking ‘‘sum’’ 

12 and inserting ‘‘amount’’; 

13 (6) in subsection (h)(3)— 

14 (A) in subparagraph (C), by striking the 

15 semicolon and inserting ‘‘; and’’; and 

16 (B) by striking subparagraphs (D) and (E) 

17 and inserting the following: 

18 ‘‘(D) such sums as may be necessary for 

19 each of fiscal years 2006 and 2007.’’; and 

20 (7) by striking ‘‘subsection (c)(5)’’ each place it 

21 appears and inserting ‘‘subsection (c)(2)’’. 

22 (b) MISBRANDED DEVICES.— 

23 (1) REPROCESSED DEVICES.—Section 502(u) of 

24 the Federal Food, Drug, and Cosmetic Act (21 

25 U.S.C. 352(u)) is amended to read as follows: 
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1 ‘‘(u)(1) Subject to paragraph (2), if it is a reproc2 essed single-use device, unless it, or an attachment there3 to, prominently and conspicuously bears the name of the 

4 manufacturer of the reprocessed device, a generally recog5 nized abbreviation of such name, or a unique and generally 

6 recognized symbol identifying such manufacturer. 

7 ‘‘(2) The Secretary may by guidance waive any re8 quirement under paragraph (1) for a reprocessed device 

9 or category of reprocessed devices if the Secretary deter10 mines that compliance with such a requirement— 

11 ‘‘(A) is not feasible due to the physical charac12 teristics of the device or category of devices; or 

13 ‘‘(B) would compromise the provision of reason14 able assurance of the safety or effectiveness of the 

15 device or category of devices.’’. 

16 (2) GUIDANCE.—Not later than 150 days after 

17 the date of enactment of this Act, the Secretary of 

18 Health and Human Services shall issue guidance 

19 specifying the device or category of devices that 

20 qualify for a waiver under section 502(u) of the Fed21 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

22 352(u)) (as amended by paragraph (1)). 

23 (3) EFFECTIVE DATE.—Section 301(b) of Pub24 lic Law 107–250 (116 Stat. 1616), as amended by 
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1 section 2(c) of Public Law 108–214 (118 Stat. 575), 

2 is amended by— 

3 (A) striking ‘‘36 months after the date of 

4 enactment of this Act’’ and inserting ‘‘9 months 

5 after the date of enactment of the Medical De6 vice User Fee Stabilization Act of 2005’’; and 

7 (B) inserting ‘‘reprocessed and’’ before 

8 ‘‘introduced’’.

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