Premarket Predictability Act of 2011

Summary

Premarket Predictability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to assign a tracking number to a medical device upon submission of: (1) an application for an exemption of a device for investigational use, (2) a request to classify a device, or (3) a premarket report or notification related to a device. Requires the Secretary to use the tracking number to record interactions between the Secretary and applicant with respect to the device. Directs the Secretary to: (1) assign a reviewer with prior review experience with the type of of device or technology involved or other relevant expertise to review an application for an exemption of a device for investigational use, and (2) evaluate whether the investigational study can be conducted ethically with reasonable risk in determining whether to grant an exemption for investigational use. Prohibits the Secretary from disapproving an application because the investigation does not or may not meet any requirement relating to the approval or clearance of a device because the Secretary believes that a different clinical testing design or plan could produce data more relevant to an approval or clearance decision. Revises the procedures relating to submission of an application to investigate a class II or a class III device, which may include a plan for determining whether the device is substantially equivalent to or is at least as safe and effective as a legally marketed device that is not subject to premarket approval requirements. Sets forth requirements for the Secretary to meet in determining the least burdensome appropriate means of evaluating medical device effectiveness that would have a reasonable likelihood of resulting in approval. Requires the Secretary to document the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding device review, approval, or exemption. Sets forth appeal procedures. Requires the Secretary to regularly publish detailed decision summaries for each clearance of a device not requiring premarket approval.

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

Timeline

1. 14 October 2011

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 14 October 2011

   Introduced

   Introduced in House

   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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  Vertaal document

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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. Altmire, Jason [D-PA-4] · D · 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. Benishek, Dan [R-MI-1] · R · Cosponsor
• Rep. Akin, W. Todd [R-MO-2] · R · Cosponsor
• Rep. Mulvaney, Mick [R-SC-5] · R · Cosponsor
• Rep. McMorris Rodgers, Cathy [R-WA-5] · R · Cosponsor
• Rep. Rokita, Todd [R-IN-4] · R · Cosponsor
• Rep. Matheson, Jim [D-UT-2] · D · Cosponsor
• · hsif00 · Standing

Related records

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