Patients Come First Act of 2011

Summary

Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and (2) not later than one year after the schedule is established, to issue a final regulation for each such device. Directs the Secretary to: (1) establish a program to assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices, (2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner, (3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall, and (4) document the basis for each Food and Drug Administration (FDA) termination of a device recall.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

1. 14 October 2011

   Introduced

   Introduced in House

   Source: IntroReferral

2. 14 October 2011

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

3. 14 October 2011

   Introduced

   Introduced in House

   Source: IntroReferral

4. 18 October 2011

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 14 October 2011 · Download file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 14 October 2011

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 14 October 2011

  ViewDownloadOpen at official source

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• Introduced in House

  summary · EN · 14 October 2011

  Open at official source

  Leesvertaling

  Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.

  Vertaal naarNL · DutchDE · GermanFR · FrenchES · SpanishIT · ItalianPL · PolishPT · PortugueseSV · SwedishDA · DanishFI · FinnishEL · GreekCS · CzechHU · HungarianRO · RomanianBG · BulgarianHR · CroatianSK · SlovakSL · SlovenianLT · LithuanianLV · LatvianET · EstonianGA · IrishMT · Maltese

  Vertaal document

  Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Sponsors

• Rep. Shimkus, John [R-IL-15] · R · Sponsor
• Rep. Gingrey, Phil [R-GA-11] · R · Sponsor
• Rep. Guthrie, Brett [R-KY-2] · R · Sponsor
• Rep. Lance, Leonard [R-NJ-7] · R · Sponsor
• Sen. Blackburn, Marsha [R-TN] · R · Sponsor
• Rep. Rogers, Mike J. [R-MI-8] · R · Sponsor
• Rep. Bilbray, Brian P. [R-CA-50] · R · Sponsor
• Rep. Burgess, Michael C. [R-TX-26] · R · Sponsor
• Rep. Barton, Joe [R-TX-6] · R · Sponsor
• Rep. Paulsen, Erik [R-MN-3] · R · Sponsor
• Sen. Cassidy, Bill [R-LA] · R · Sponsor
• Rep. Latta, Robert E. [R-OH-5] · R · Sponsor
• Rep. Culberson, John Abney [R-TX-7] · R · Cosponsor
• Rep. Walden, Greg [R-OR-2] · R · Cosponsor
• Rep. Akin, W. Todd [R-MO-2] · R · Cosponsor
• Rep. Mulvaney, Mick [R-SC-5] · R · Cosponsor
• Rep. Rokita, Todd [R-IN-4] · R · Cosponsor
• Rep. Gosar, Paul A. [R-AZ-9] · R · Cosponsor
• · hsif00 · Standing

Related records

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