H.R. 5341 (112th): Sentinel Assurance for Effective Devices Act of 2012

Introduced:
May 07, 2012 (112th Congress, 2011–2013)
Sponsor:
Rep. Lois Capps [D-CA23]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. H.R. stands for House of Representatives bill.

(About Ads | Go Ad-Free for $5)
Status

This bill was introduced on May 7, 2012, in a previous session of Congress, but was not enacted.

Progress
Introduced May 07, 2012
Referred to Committee May 07, 2012
Cosponsors
none
Committees

House Energy and Commerce

The committee chair determines whether a bill will move past the committee stage.

Full Title

To improve postmarket risk identification and analysis with respect to devices, and for other purposes.

Summary

No summaries available.

Text

Read Bill Text »

Last updated May 07, 2012.
4 pages

Primary Source

View on THOMAS (The Library of Congress)

GovTrack gets most information from THOMAS, which is updated generally one day after events occur. Activity since the last update may not be reflected here.

Citation

Click a format for a citation suggestion:

GovTrack’s Bill Summary

We don’t have a summary available yet.

Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

5/7/2012--Introduced.
Sentinel Assurance for Effective Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to:
(1) amend the new drug approval application procedures to make the postmarket risk identification and analysis system applicable, with certain exceptions, to devices;
(2) give priority to class II and class III devices; and
(3) engage outside stakeholders in development of the system and gather information from them regarding the content of an effective sentinel program through measures involving the public.
Exempts the collection of voluntary information from health care providers for purposes of postmarket risk identification for devices from application of provisions for the coordination of federal information policy.
Requires the Secretary to issue final regulations concerning a unique device identification system no later than December 31, 2012, and to implement such system for class III devices no later than one year after the date of issuance of final regulations; for implantable, life-sustaining, and life-supporting devices no later than three years after such date; and for all other devices no later than five years after such date.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

The House Democratic Caucus does not provide summaries of bills.

So, yes, we display the House Republican Conference’s summaries when available even if we do not have a Democratic summary available. That’s because we feel it is better to give you as much information as possible, even if we cannot provide every viewpoint.

We’ll be looking for a source of summaries from the other side in the meanwhile.

The bill contains the following citations to other parts of U.S. law:

United States Code

The United States Code is the compilation of permanent laws enacted by Congress. Temporary and other non-permanent laws do not appear in the United States Code. (About half of the United States Code is the law itself, called positive law. The other half is merely a compilation of the laws but has no legal significance.)

Other Citations

  • 44 U.S.C. Chapter 35