US Congress House Bill 3211 (Prior Session Legislation)

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Spectrum: Partisan Bill (Republican 12-0)
Status: Introduced on October 14 2011 - 25% progression, died in committee
Action: 2011-10-18 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

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.

Humanitarian Device Reform Act of 2011

Rep. Charles Bass [R-NH]	Sen. Marsha Blackburn [R-TN]	Rep. John Culberson [R-TX]	Rep. Brett Guthrie [R-KY]
Rep. John Kline [R-MN]	Rep. Leonard Lance [R-NJ]	Rep. Robert Latta [R-OH]	Rep. Patrick Meehan [R-PA]
Rep. Erik Paulsen [R-MN]	Rep. Mike J. Rogers [R-MI]	Rep. Aaron Schock [R-IL]	Rep. John Shimkus [R-IL]

Date	Chamber	Action
2011-10-18	House	Referred to the Subcommittee on Health.
2011-10-14	House	Referred to the House Committee on Energy and Commerce.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/house-bill/3211/all-info
Text	https://www.congress.gov/112/bills/hr3211/BILLS-112hr3211ih.pdf