I 

112TH CONGRESS 

1ST SESSION H. R. 3208 

To reaffirm the Safe Medical Devices Act of 1990 by requiring that the 

Secretary of Health and Human Services establish a schedule and issue 

regulations as required under section 515(i) of the Federal Food, Drug, 

and Cosmetic Act, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 14, 2011 

Mr. SHIMKUS (for himself, Mr. GINGREY of Georgia, Mr. GUTHRIE, Mr. 

LANCE, Mrs. BLACKBURN, Mr. ROGERS of Michigan, Mr. BILBRAY, Mr. 

BURGESS, Mr. BARTON of Texas, Mr. PAULSEN, Mr. CASSIDY, and Mr. 

LATTA) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services 

establish a schedule and issue regulations as required 

under section 515(i) of the Federal Food, Drug, and 

Cosmetic Act, and for other purposes. 

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 ‘‘Patients Come First 

5 Act of 2011’’. 


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1 SEC. 2. FINDINGS. 

2 Congress finds as follows: 

3 (1) Under the Safe Medical Devices Act of 

4 1990 (Public Law 101–629), Congress amended sec5 tion 515 of the Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 360e) to require the Food and Drug 

7 Administration to reclassify preamendment class III 

8 devices to a lower class or to require them to go 

9 through the premarket approval process. 

10 (2) The Food and Drug Administration still has 

11 not complied with the mandate of Congress under 

12 such Act, jeopardizing the health of the Nation’s pa13 tients. 

14 SEC. 3. ESTABLISHMENT OF SCHEDULE AND PROMULGA15 TION OF REGULATION. 

16 (a) ESTABLISHMENT OF SCHEDULE.—Not later than 

17 90 days after the date of enactment of this Act, the Sec18 retary of Health and Human Services shall establish the 

19 schedule referred to in section 515(i)(3) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)). 

21 (b) REGULATION.—Not later than one year after the 

22 date that the schedule is established under such section 

23 515(i)(3) (as required by subsection (a)) the Secretary 

24 shall issue a final regulation under section 515(b) of such 

25 Act for each device that the Secretary requires to remain 


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1 in class III through a determination under section 

2 515(i)(2) of such Act. 

3 SEC. 4. PROGRAM TO IMPROVE THE DEVICE RECALL SYS4 TEM. 

5 Chapter V of the Federal Food, Drug, and Cosmetic 

6 Act is amended by inserting after section 518 (21 U.S.C. 

7 360h) the following: 

8 ‘‘SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL 

9 SYSTEM. 

10 ‘‘(a) IN GENERAL.—The Secretary shall— 

11 ‘‘(1) establish a program to routinely and sys12 tematically assess information relating to device re13 calls and use such information to proactively identify 

14 strategies for mitigating health risks presented by 

15 defective or unsafe devices; 

16 ‘‘(2) clarify procedures for conducting device re17 call audit checks to improve the ability of investiga18 tors to perform those checks in a consistent manner; 

19 ‘‘(3) develop detailed criteria for assessing 

20 whether a person performing a device recall has per21 formed an effective correction or action plan for the 

22 recall; and 

23 ‘‘(4) document the basis for each termination 

24 by the Food and Drug Administration of a device re25 call. 


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1 ‘‘(b) ASSESSMENT CONTENT.—The program estab2 lished under subsection (a)(1) shall, at a minimum, iden3 tify— 

4 ‘‘(1) trends in the number and types of device 

5 recalls; 

6 ‘‘(2) devices that are most frequently the sub7 ject of a recall; and 

8 ‘‘(3) underlying causes of device recalls.’’. 

Æ 


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