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 Com-
mittee on Energy and Commerce 
A BILL 
To reaffirm the Safe Medical Devices Act of 1990 by requir-
ing 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. 
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 ‘‘Patients Come First 
Act of 2011’’. 
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SEC. 2. FINDINGS. 
Congress finds as follows: 
(1) Under the Safe Medical Devices Act of 
1990 (Public Law 101–629), Congress amended sec-
tion 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e) to require the Food and Drug 
Administration to reclassify preamendment class III 
devices to a lower class or to require them to go 
through the premarket approval process. 
(2) The Food and Drug Administration still has 
not complied with the mandate of Congress under 
such Act, jeopardizing the health of the Nation’s pa-
tients. 
SEC. 3. ESTABLISHMENT OF SCHEDULE AND PROMULGA-
TION OF REGULATION. 
(a) ESTABLISHMENT OF SCHEDULE.—Not later than 
90 days after the date of enactment of this Act, the Sec-
retary of Health and Human Services shall establish the 
schedule referred to in section 515(i)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360e(i)(3)). 
(b) REGULATION.—Not later than one year after the 
date that the schedule is established under such section 
515(i)(3) (as required by subsection (a)) the Secretary 
shall issue a final regulation under section 515(b) of such 
Act for each device that the Secretary requires to remain 
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in class III through a determination under section 
515(i)(2) of such Act. 
SEC. 4. PROGRAM TO IMPROVE THE DEVICE RECALL SYS-
TEM. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 518 (21 U.S.C. 
360h) the following: 
‘‘SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL 
SYSTEM. 
‘‘(a) IN GENERAL.—The Secretary shall— 
‘‘(1) establish a program to routinely and sys-
tematically assess information relating to device re-
calls and use such information to proactively identify 
strategies for mitigating health risks presented by 
defective or unsafe devices; 
‘‘(2) clarify procedures for conducting device re-
call audit checks to improve the ability of investiga-
tors to perform those checks in a consistent manner; 
‘‘(3) develop detailed criteria for assessing 
whether a person performing a device recall has per-
formed an effective correction or action plan for the 
recall; and 
‘‘(4) document the basis for each termination 
by the Food and Drug Administration of a device re-
call. 
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‘‘(b) ASSESSMENT CONTENT.—The program estab-
lished under subsection (a)(1) shall, at a minimum, iden-
tify— 
‘‘(1) trends in the number and types of device 
recalls; 
‘‘(2) devices that are most frequently the sub-
ject of a recall; and 
‘‘(3) underlying causes of device recalls.’’. 
Æ 
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