HR 3493 · 108th Congress · Health
Medical Devices Technical Corrections Act
Bill Progress
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Introduced✓
Committee✓
House Vote4
Senate5
EnactedLatest: Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.(2004-01-28)
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Plain Language Summary
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Medical Devices Technical Corrections Act of 2003 - Amends the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of 2002, to revise medical device fee schedule provisions. Revises facility inspection and accredited inspector provisions, including permitting a company that markets at least one medical device in the United States and one medical device in another country to satisfy inspection requirements by: (1) certifying that a foreign country recognizes Food and Drug Administration (FDA) inspection; and/or (2) marketing its devices in a country that recognizes third party inspectors. (Current law requires a company to meet both requirements.) Eliminates the provision deeming a device introduced into interstate commerce within 18 months of enactment of the Medical Device User Fee and Modernization Act of 2002 (October 26, 2002) to be misbranded if the identification of the manufacturer is not conspicuously displayed. Requires (currently authorizes) the Secretary of Health and Human Services to conduct or support research on the long-term effects of silicone breast implants. Permits a person to sell a device under the humanitarian…
Summarized by Claude AI · Non-partisan · For informational purposes only