Medical Device Regulatory Flexibility Act

Summary

Medical Device Regulatory Flexibility Act - Amends the Federal Food, Drug, and Cosmetic Act to modify requirements regarding the initial classification of medical devices. Authorizes the Secretary of Health and Human Services to issue notices to identify and list nationally and internationally recognized standards that: (1) shall be the special controls to which class II devices must comply; (2) may be used in establishing (for device classification) the equivalence of one device to another; and (3) may be used in considering premarket approval of a class III device. Directs the Secretary to accept a certification that a device conforms to such a standard.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 1 May 1997

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• Introduced in House (PDF)

  Introduced in House · EN · 1 May 1997

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• Introduced in House

  summary · EN · 1 May 1997

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