US Congress House Bill 5341 (Prior Session Legislation)

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Spectrum: Partisan Bill (Democrat 1-0)
Status: Introduced on May 7 2012 - 25% progression, died in committee
Action: 2012-05-11 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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

Rep. Lois Capps [D-CA]

Date	Chamber	Action
2012-05-11	House	Referred to the Subcommittee on Health.
2012-05-07	House	Referred to the House Committee on Energy and Commerce.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/5341/all-info
Text	https://www.congress.gov/112/bills/hr5341/BILLS-112hr5341ih.pdf