Medical Device User Fee and Modernization Act of 2002

Summary

Medical Device Amendments of 2001 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish within the Office of the Commissioner of Food and Drugs the Office of Combination Products and Product Jurisdiction to designate the component of the Food and Drug Administration with primary or exclusive responsibility for the premarket and postmarket regulation of drugs, devices, and biological products. Authorizes the Commissioner to establish a fellowship program to augment the scientific expertise of the agency component responsible for regulating devices. Revises or sets forth requirements concerning: (1) facility inspection by nongovernment inspectors; (2) outside expert review (accredited third parties) of applications for devices subject to premarket notification; (3) designating priority devices for the treatment of serious diseases or conditions; (4) manufacturers and importers reports only for types of devices requiring malfunction reporting; (5) labeling for intended use of devices found substantially equivalent to legally marketed devices; (6) notification of false or misleading proposed labeling: (7) approving supplements to approved applications seeking to add a specification of a subpopulation under an approved condition of use; (8) using the least burdensome scientific evidence required to demonstrate a device's effectiveness; (9) investigational plans examining the safety, effectiveness or substantial equivalence of a device; (10) notification of deficiencies; (11) the guidance development process utilizing nongovernment employees; (12) modular review of applications; (13) registration; and (14) electronic labeling.

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Documents

8 official files

• Engrossed in House (text)

  Engrossed in House · EN · 9 October 2002

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• Engrossed in House (PDF)

  Engrossed in House · EN · 9 October 2002

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• Passed House amended

  summary · EN · 9 October 2002

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• Reported in House (text)

  Reported in House · EN · 7 October 2002

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• Reported in House (PDF)

  Reported in House · EN · 7 October 2002

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• Introduced in House (text)

  Introduced in House · EN · 20 December 2001

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• Introduced in House (PDF)

  Introduced in House · EN · 20 December 2001

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• Introduced in House

  summary · EN · 20 December 2001

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