US Congress Senate Bill 2193 (Prior Session Legislation)

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Spectrum: Moderate Partisan Bill (Democrat 4-1)
Status: Introduced on March 15 2012 - 25% progression, died in committee
Action: 2012-03-15 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Pending: Senate Health, Education, Labor, And Pensions Committee
Text: Latest bill text (Introduced) [PDF]

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.

Ensuring Safe Medical Devices for Patients

Sen. Jeff Merkley [D-OR]	Sen. Michael Bennet [D-CO]	Sen. Richard Blumenthal [D-CT]	Sen. Chuck Grassley [R-IA]
Sen. Herb Kohl [D-WI]

Date	Chamber	Action
2012-03-15	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/112th-congress/senate-bill/2193/all-info
Text	https://www.congress.gov/112/bills/s2193/BILLS-112s2193is.pdf