Sentinel Assurance for Effective Devices Act of 2012

Summary

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.

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Timeline

1. 7 May 2012

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 7 May 2012

   Introduced

   Introduced in House

   Source: IntroReferral

3. 7 May 2012

   Introduced

   Introduced in House

   Source: IntroReferral

4. 11 May 2012

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 7 May 2012 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 7 May 2012

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 7 May 2012

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 7 May 2012

  Open at official source

Sponsors

• Rep. Capps, Lois [D-CA-24] · D · Sponsor
• · hsif00 · Standing

Related records

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