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S 1995 112th Congress Senate

Medical Device Patient Safety Act

Official 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.

Introduced: December 14, 2011 Introduced by: Grassley, Chuck Republican · Iowa See on congress.gov
Health Business recordsDrug safety, medical device, and laboratory regulationGovernment information and archivesHealth technology, devices, supplies
This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Dec 14, 2011
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Dec 14, 2011
Introduced in Senate
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 Latest action December 14, 2011

Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

 Plain-English summary Congressional Research Service

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.

 Related & companion bills 1
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
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APA
U.S. Congress. (2026). S. 1995: Medical Device Patient Safety Act. 112th Congress. Open America. https://openamerica.io/bill/112-S-1995/
MLA
"S. 1995: Medical Device Patient Safety Act." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-S-1995/.
Bluebook (legal)
S. 1995, 112th Cong. (2026), https://openamerica.io/bill/112-S-1995/.
Markdown link
[S. 1995: Medical Device Patient Safety Act](https://openamerica.io/bill/112-S-1995/)
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