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S 2193 112th Congress Senate Health Administrative law and regulatory procedures Department of Health and Human Services Health technology, devices, supplies Product safety and quality

Ensuring Safe Medical Devices for Patients

Introduced: March 15, 2012 Introduced by: Merkley, Jeff Democratic · Oregon See on congress.gov
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 Everywhere this bill has been 2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 15, 2012
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 15, 2012
Introduced in Senate
 Plain-English summary Congressional Research Service

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.

What's happening now March 15, 2012

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

 Committees of jurisdiction 1
 Cosponsors 3
All 3 Democratic 2 Republican 1