H.R. 3208 (112th): Patients Come First Act of 2011

Oct 14, 2011 (112th Congress, 2011–2013)
Died (Referred to Committee)
John Shimkus
Representative for Illinois's 19th congressional district
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Last Updated
Oct 14, 2011
4 pages

This bill was introduced on October 14, 2011, in a previous session of Congress, but was not enacted.

Introduced Oct 14, 2011
Referred to Committee Oct 14, 2011
Full Title

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.


No summaries available.

17 cosponsors (17R) (show)

House Energy and Commerce


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Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

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.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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