S. 2193 · 112th Congress
Ensuring Safe Medical Devices for Patients
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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.
D
MerkleySponsor4 cosponsors · 3 D, 1 R
3 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
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;…
What it does: CRS summary · 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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Ensuring Safe Medical Devices for Patients
Latest action (Mar 15, 2012): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Mar 15, 2012
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.