US Congress House Bill 3208 (Prior Session Legislation)

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Sponsorship: Partisan Bill (Republican 18)
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]

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.

Patients Come First Act of 2011

Rep. John Shimkus [R-IL]	Rep. Todd Akin [R-MO]	Rep. Joe Barton [R-TX]	Rep. Brian Bilbray [R-CA]
Sen. Marsha Blackburn [R-TN]	Rep. Michael Burgess [R-TX]	Sen. Bill Cassidy [R-LA]	Rep. John Culberson [R-TX]
Rep. Phil Gingrey [R-GA]	Rep. Paul Gosar [R-AZ]	Rep. Brett Guthrie [R-KY]	Rep. Leonard Lance [R-NJ]
Rep. Robert Latta [R-OH]	Rep. Mick Mulvaney [R-SC]	Rep. Erik Paulsen [R-MN]	Rep. Mike J. Rogers [R-MI]
Rep. Todd Rokita [R-IN]	Rep. Greg Walden [R-OR]

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/3208/all-info
Text	https://www.congress.gov/112/bills/hr3208/BILLS-112hr3208ih.pdf