Humanitarian Device Reform Act of 2011

Summary

Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under the humanitarian device exemption is 4,000 individuals per year so affected.

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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 · Official 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

• Introduced in House

  summary · EN · 14 October 2011

  Open at official source

Sponsors

• Rep. Bass, Charles F. [R-NH-2] · R · Sponsor
• Rep. Rogers, Mike J. [R-MI-8] · R · Sponsor
• Leonard Lance · R · Sponsor
• Marsha Blackburn · R · Sponsor
• Brett Guthrie · R · Sponsor
• Erik Paulsen · R · Sponsor
• Rep. Latta, Robert E. [R-OH-5] · R · Sponsor
• JOHN SHIMKUS · R · Sponsor
• JOHN CULBERSON · R · Cosponsor
• Rep. Kline, John [R-MN-2] · R · Cosponsor
• Rep. Schock, Aaron [R-IL-18] · R · Cosponsor
• Patrick Meehan · R · Cosponsor
• · hsif00 · Standing

Related records

No cross-record relationships stored yet.