I 
112TH CONGRESS 
2D SESSION 
H. R. 5341 
To improve postmarket risk identification and analysis with respect to devices, 
and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 7, 2012 
Mrs. CAPPS introduced the following bill; which was referred to the Committee 
on Energy and Commerce 
A BILL 
To improve postmarket risk identification and analysis with 
respect to devices, 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 ‘‘Sentinel Assurance for 
Effective Devices Act of 2012’’. 
SEC. 2. INCLUSION OF DEVICES IN POSTMARKET RISK 
IDENTIFICATION 
AND 
ANALYSIS 
SYSTEM; 
UNIQUE DEVICE IDENTIFICATION SYSTEM. 
(a) INCLUSION OF DEVICES IN POSTMARKET RISK 
IDENTIFICATION AND ANALYSIS SYSTEM.—Section 522 of 
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the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360l) is amended by adding at the end the following: 
‘‘(d) INCLUSION OF DEVICES IN THE POSTMARKET 
RISK IDENTIFICATION AND ANALYSIS SYSTEM.— 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), the Secretary shall amend the procedures 
established 
and 
maintained 
under 
section 
505(k)(3)(C) in order to expand the postmarket risk 
identification and analysis system established under 
such section to include and apply to devices. 
‘‘(2) EXCEPTIONS.—In carrying out this sub-
section: 
‘‘(A) The Secretary shall not apply the 
procedures of section 505(k)(3)(C)(i)(II) to de-
vices. 
‘‘(B) Section 505(k)(3)(C)(i)(III)(bb) is 
deemed to refer to private sector health-related 
electronic data (such as medical device utiliza-
tion data, health insurance claims data, and 
procedure and device registries). 
‘‘(C) 
Section 
505(k)(3)(C)(iv)(II) 
is 
deemed to refer to the Data Extraction and 
Longitudinal Time Analysis system instead of 
the Vaccine Safety Datalink. 
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‘‘(3) PRIORITY.—In carrying out this sub-
section, 
the 
Secretary 
shall 
give 
priority 
to 
postmarket risk identification and analysis with re-
spect to class II and class III devices. 
‘‘(4) STAKEHOLDER INPUT.—To help ensure ef-
fective implementation of the system described in 
paragraph (1) with respect to devices, the Secretary 
shall engage outside stakeholders in development of 
the system, and gather information from outside 
stakeholders regarding the content of an effective 
sentinel program, through a public hearing, advisory 
committee meeting, maintenance of a public docket, 
or other similar public measures. 
‘‘(5) DATA.—In carrying out this subsection, 
the Secretary shall use data with respect to devices 
cleared under section 510(k) or approved under sec-
tion 515, which may include claims data, patient 
survey data, standardized analytic files that allow 
for the pooling and analysis of data from disparate 
data environments, and any other data deemed ap-
propriate by the Secretary. 
‘‘(6) VOLUNTARY
SURVEYS.—Chapter 35 of 
title 44, United States Code, shall not apply to the 
collection of voluntary information from health care 
providers, such as voluntary surveys or question-
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naires, initiated by the Secretary for purposes of 
postmarket risk identification for devices.’’. 
(b) UNIQUE DEVICE IDENTIFICATION SYSTEM.— 
Section 519(f) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360i(f)) is amended— 
(1) by striking ‘‘The Secretary shall promul-
gate’’ and inserting ‘‘Not later than December 31, 
2012, the Secretary shall issue final’’; and 
(2) by adding at the end the following: ‘‘The 
Secretary shall implement the unique device identi-
fication system under this subsection for class III 
devices not later than 1 year after the date on which 
the final regulations are issued, for implantable, life- 
sustaining, and life-supporting devices not later than 
3 years after such date, and for all other devices not 
later than 5 years after such date.’’. 
Æ 
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