Food and Drug Administration Accountability and Transparency Act

Summary

Food and Drug Administration Accountability and Transparency Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to publish in the Federal Register postmarket surveillance plans for medical devices, unless such information is exempted under the Freedom of Information Act. Subjects medical device manufacturers that fail to comply with postmarket surveillance requirements to civil monetary penalties. Requires the Secretary to take into consideration whether the manufacturer is making efforts toward correcting the violation in determining the amount of the civil penalty. Authorizes the Secretary to order notification of health personnel and other relevant persons if a violation of postmarket surveillance requirements of a device presents an unreasonable risk of substantial harm to the public health, such notification is necessary to eliminate such risk, and no more practicable means is available to eliminate such risk.

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Documents

3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 15 May 2008

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 15 May 2008

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• Introduced in Senate

  summary · EN · 15 May 2008

  Open at official source

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