3.0.0 5341 2023-01-11T13:23:02Z 2023-01-11T13:23:02Z House H HR 2012-05-07 112 From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]By Mrs. CAPPS:H.R. 5341.Congress has the power to enact this legislation pursuantto the following:Article I, Section 8, Clause 1 of the United StatesConstitution.[Page H2321]]]> hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2012-05-11T18:43:48Z Referred to 2012-05-07T18:05:20Z 2012-05-11 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2012-05-07 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2012-05-07 Introduced in House IntroReferral Intro-H 9 Library of Congress 2012-05-07 Introduced in House IntroReferral 1000 9 Library of Congress C001036 Rep. Capps, Lois [D-CA-23] LOIS CAPPS D CA 23 N Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation Food and Drug Administration (FDA) Government information and archives Health information and medical records Health technology, devices, supplies Product safety and quality Health 00 2012-05-07 Introduced in House 2012-07-05T16:44:06Z 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.

]]> Sentinel Assurance for Effective Devices Act of 2012 Display Title Sentinel Assurance for Effective Devices Act of 2012 Official Title as Introduced To improve postmarket risk identification and analysis with respect to devices, and for other purposes. Introduced in House IH Short Titles as Introduced Sentinel Assurance for Effective Devices Act of 2012 Introduced in House 2012-05-07T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-112hr5341ih/xml/BILLS-112hr5341ih.xml 2012-05-11 Referred to the Subcommittee on Health. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.