HR 5866 · 112th Congress · Health

Medical Device Patient Safety Act

Introduced 2012-05-30· Sponsored by Rep. Braley, Bruce L. [D-IA-1]· House

Bill Progress

Introduced
2
Committee
3
House Vote
4
Senate
5
Enacted
Latest: Referred to the Subcommittee on Health.(2012-06-01)

Plain Language Summary

[AI summary unavailable — showing source text] 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 terminati…

Summarized by Claude AI · Non-partisan · For informational purposes only