Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congressional Research Service
Official summary
Version 00 · Introduced in Senate · Mar 15, 2012
Ensuring Safe Medical Devices for Patients - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to: (1) amend procedures under such Act to expand the postmarket risk identification and analysis system to include and apply to devices in a comparable manner as such system includes and applies to drugs; and (2) ensure that such amended procedures give priority for inclusion in the system to class III and class II devices that are implantable, life-supporting, or life-sustaining or that pose significant risk to users.
Directs the Secretary to: (1) issue final regulations establishing a unique device identification system for medical devices by December 31, 2012, and (2) implement the system not later than one year after the final regulations are issued.
No related bills are listed in this snapshot. This does not establish whether the proposal has appeared in earlier Congresses.
Source last updated: Aug 14, 2025. Consult Congress.gov for the current record.
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