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. 

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 ‘‘Sentinel Assurance for 

5 Effective Devices Act of 2012’’. 

6 SEC. 2. INCLUSION OF DEVICES IN POSTMARKET RISK 

7 IDENTIFICATION AND ANALYSIS SYSTEM; 

8 UNIQUE DEVICE IDENTIFICATION SYSTEM. 

9 (a) INCLUSION OF DEVICES IN POSTMARKET RISK

10 IDENTIFICATION AND ANALYSIS SYSTEM.—Section 522 of 


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1 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

2 360l) is amended by adding at the end the following: 

3 ‘‘(d) INCLUSION OF DEVICES IN THE POSTMARKET

4 RISK IDENTIFICATION AND ANALYSIS SYSTEM.— 

5 ‘‘(1) IN GENERAL.—Except as provided in para6 graph (2), the Secretary shall amend the procedures 

7 established and maintained under section 

8 505(k)(3)(C) in order to expand the postmarket risk 

9 identification and analysis system established under 

10 such section to include and apply to devices. 

11 ‘‘(2) EXCEPTIONS.—In carrying out this sub12 section: 

13 ‘‘(A) The Secretary shall not apply the 

14 procedures of section 505(k)(3)(C)(i)(II) to de15 vices. 

16 ‘‘(B) Section 505(k)(3)(C)(i)(III)(bb) is 

17 deemed to refer to private sector health-related 

18 electronic data (such as medical device utiliza19 tion data, health insurance claims data, and 

20 procedure and device registries). 

21 ‘‘(C) Section 505(k)(3)(C)(iv)(II) is 

22 deemed to refer to the Data Extraction and 

23 Longitudinal Time Analysis system instead of 

24 the Vaccine Safety Datalink. 


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1 ‘‘(3) PRIORITY.—In carrying out this sub2 section, the Secretary shall give priority to 

3 postmarket risk identification and analysis with re4 spect to class II and class III devices. 

5 ‘‘(4) STAKEHOLDER INPUT.—To help ensure ef6 fective implementation of the system described in 

7 paragraph (1) with respect to devices, the Secretary 

8 shall engage outside stakeholders in development of 

9 the system, and gather information from outside 

10 stakeholders regarding the content of an effective 

11 sentinel program, through a public hearing, advisory 

12 committee meeting, maintenance of a public docket, 

13 or other similar public measures. 

14 ‘‘(5) DATA.—In carrying out this subsection, 

15 the Secretary shall use data with respect to devices 

16 cleared under section 510(k) or approved under sec17 tion 515, which may include claims data, patient 

18 survey data, standardized analytic files that allow 

19 for the pooling and analysis of data from disparate 

20 data environments, and any other data deemed ap21 propriate by the Secretary. 

22 ‘‘(6) VOLUNTARY SURVEYS.—Chapter 35 of 

23 title 44, United States Code, shall not apply to the 

24 collection of voluntary information from health care 

25 providers, such as voluntary surveys or questionVerDate Mar 15 2010 06:14 May 10, 2012 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5341.IH H5341

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1 naires, initiated by the Secretary for purposes of 

2 postmarket risk identification for devices.’’. 

3 (b) UNIQUE DEVICE IDENTIFICATION SYSTEM.— 

4 Section 519(f) of the Federal Food, Drug, and Cosmetic 

5 Act (21 U.S.C. 360i(f)) is amended— 

6 (1) by striking ‘‘The Secretary shall promul7 gate’’ and inserting ‘‘Not later than December 31, 

8 2012, the Secretary shall issue final’’; and 

9 (2) by adding at the end the following: ‘‘The 

10 Secretary shall implement the unique device identi11 fication system under this subsection for class III 

12 devices not later than 1 year after the date on which 

13 the final regulations are issued, for implantable, life14 sustaining, and life-supporting devices not later than 

15 3 years after such date, and for all other devices not 

16 later than 5 years after such date.’’. 

Æ 


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