S.2193 - Ensuring Safe Medical Devices for Patients112th Congress (2011-2012)
|Sponsor:||Sen. Merkley, Jeff [D-OR] (Introduced 03/15/2012)|
|Committees:||Senate - Health, Education, Labor, and Pensions|
|Latest Action:||03/15/2012 Read twice and referred to the Committee on Health, Education, Labor, and Pensions.|
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Summary: S.2193 — 112th Congress (2011-2012)All Bill Information (Except Text)
Introduced in Senate (03/15/2012)
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.