S.2193 - Ensuring Safe Medical Devices for Patients

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. view all titles (2)

All Bill Titles

  • Official: 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. as introduced.
  • Short: Ensuring Safe Medical Devices for Patients as introduced.

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Introduced
 
Senate
Passes
 
House
Passes
 
President
Signs
 

 
03/15/12
 
 
 
 
 
 
 

Official Summary

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 i

Official Summary

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.

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Organizations Supporting S.2193

  • Association of American Medical Colleges
  • Consumers Union
  • National Women’s Health Network
  • The National Research Center for Women & Families
  • Health Care Supply Chain Association
  • American Association of Retired Persons
  • ...and 24 more. See all.

Organizations Opposing S.2193

  • None via MapLight at this time.




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