Ensuring Safe Medical Devices for Patients

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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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 15 March 2012

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 15 March 2012

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• Introduced in Senate

  summary · EN · 15 March 2012

  Open at official source

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