U.S. Congress - H.R.3208 Patients Come First Act of 2011
H.R.3208 - Patients Come First Act of 2011
To reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services establish a schedule and issue regulations as required under section 515(i) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. view all titles (2)
All Bill Titles
- Short: Patients Come First Act of 2011 as introduced.
- Official: To reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services establish a schedule and issue regulations as required under section 515(i) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. as introduced.
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Official Summary
10/14/2011--Introduced.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 requiringOfficial Summary
10/14/2011--Introduced.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.
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Recent News Coverage
Rep. Shimkus Introduces Bill to Require Establishment of Schedule, Issuance of ...
John Shimkus, R-Ill., has introduced legislation (HR 3208) to "reaffirm the Safe Medical Devices Act of 1990 by requiring that the Secretary of Health and Human Services establish a schedule and issue regulations as required under section 515(i) of t
Recent Blog Coverage
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Eye on Congress: Medical device bills to watch (Part 1)
Patients Come First Act of 2011 (HR 3208) Status: Referred to the Subcommittee on Health Companion bill: S3847. This bill would require the FDA to finish evaluation of pre-amendment devices. The summary notes that ...
Eye on Congress: Medical device bills to watch (Part 1)
Patients Come First Act of 2011 (HR 3208) Status: Referred to the Subcommittee on Health Companion bill: S3847. This bill would require the FDA to finish evaluation of pre-amendment devices. The summary notes that ...
Eye on Congress: Medical device bills to watch (Part 1)
Patients Come First Act of 2011 (HR 3208) Status: Referred to the Subcommittee on Health Companion bill: S3847. This bill would require the FDA to finish evaluation of pre-amendment devices. The summary notes that ...
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