S. 1995 · 112th Congress
Medical Device Patient Safety Act
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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.
R
GrassleySponsor2 cosponsors · 2 D
2 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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.
What it does: CRS summary · Introduced in Senate · Dec 14, 2011
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Medical Device Patient Safety Act
Latest action (Dec 14, 2011): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Dec 14, 2011
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.