S. 1995 (112th): Medical Device Patient Safety Act

Dec 14, 2011 (112th Congress, 2011–2013)
Died (Referred to Committee)
See Instead:

H.R. 5866 (same title)
Referred to Committee — May 30, 2012

Charles “Chuck” Grassley
Senior Senator from Iowa
Read Text »
Last Updated
Dec 14, 2011
11 pages
Related Bills
H.R. 5866 (identical)

Referred to Committee
Last Action: May 30, 2012


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

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

A bill to enhance Food and Drug Administration oversight of medical device recalls, to provide for the conditional clearance of certain medical devices, and for other purposes.


No summaries available.

2 cosponsors (2D) (show)

Senate Health, Education, Labor, and Pensions

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Primary Source

THOMAS.gov (The Library of Congress)

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S. stands for Senate bill.

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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.

Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls.
Requires the program to routinely and systematically assess:
(1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and
(2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device.
Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices.
Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall.
Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action.
Requires the Secretary to document and publish specified information concerning termination of a recall.
Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce.
Permits the Secretary, as part of such conditional clearance, to:
(1) impose specified restrictions on the sale, distribution, or use of the device;
(2) require specified labeling for the device; and
(3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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