PlainBillCongress, translated.Legislation. Context. Public interest.Referred to the Subcommittee on Health.
Congressional Research Service
Version 00 · Introduced in House · May 7, 2012
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.
People & committees
Rep. Capps, Lois [D-CA-23] · D–CA
Legislative record
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Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Introduced in House
Primary sources
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Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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