H.R. 3208 · 112th Congress
Patients Come First Act of 2011
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Never voted on. It didn't reach a floor vote before the 112th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
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ShimkusSponsor17 cosponsors · 17 R
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Barton
BB
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Bilbray
MB
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Blackburn
MB
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Burgess
BC
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Cassidy
PG
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Gingrey
BG
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Guthrie
RL
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Latta
LL
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Lance
EP
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Paulsen
MR
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Rogers
JC
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Culberson
GW
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Walden
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Akin
MM
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Mulvaney
TR
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Rokita
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Gosar11 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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…
What it does: CRS summary · Introduced in House · Oct 14, 2011
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Patients Come First Act of 2011
Latest action (Oct 18, 2011): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: Oct 14, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.