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S 2193 112th Congress Senate

Ensuring Safe Medical Devices for Patients

Official title: A bill to require the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation… Show full official titleShow less

Official title: A bill to require the Food and Drug Administration to include devices in the postmarket risk identification and analysis system, to expedite the implementation of the unique device identification system for medical devices, and for other purposes.

Introduced: March 20, 2012 Introduced by: Merkley, Jeff Democratic · Oregon See on congress.gov
Health Administrative law and regulatory proceduresDepartment of Health and Human ServicesHealth technology, devices, suppliesProduct safety and quality
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This bill died when the 112th Congress ended
It never became law before the 112th Congress (2011–2012) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 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
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 Latest action March 15, 2012

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

 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.

 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Cosponsors 3
All 3 Democratic 2 Republican 1
D
Blumenthal, Richard
Connecticut · Mar 20, 2012
 D
Bennet, Michael F.
Colorado · Mar 15, 2012
 R
Grassley, Chuck
Iowa · Mar 15, 2012
Cite this page click to expand
APA
U.S. Congress. (2026). S. 2193: Ensuring Safe Medical Devices for Patients. 112th Congress. Open America. https://openamerica.io/bill/112-S-2193/
MLA
"S. 2193: Ensuring Safe Medical Devices for Patients." 112th Congress, 2026, Open America, https://openamerica.io/bill/112-S-2193/.
Bluebook (legal)
S. 2193, 112th Cong. (2026), https://openamerica.io/bill/112-S-2193/.
Markdown link
[S. 2193: Ensuring Safe Medical Devices for Patients](https://openamerica.io/bill/112-S-2193/)
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