Alabama Tissue Center v. Sullivan

975 F.2d 373 (1992)

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Alabama Tissue Center v. Sullivan

United States Court of Appeals for the Seventh Circuit
975 F.2d 373 (1992)

MP

Facts

Six not-for-profit heart valve allograft processors filed a petition for review contesting a Food and Drug Administration (FDA) Notice of Applicability of a Final Rule (NAFR), stating that replacement heart valve allografts are subject to the FDA’s final rule that would require the filing of a pre-market approval application for all heart valves and their equivalents. A heart valve allograft is a human heart valve that has been processed and preserved so it can be stored until it is needed for implantation into a human recipient. The processors argued that their heart valve allografts did not fall within the final rule because they were not “implants” within the meaning of the Federal Food, Drug, and Cosmetics Act’s definition of a medical device, and that the FDA never intended to include human heart valve allografts within its definition of replacement heart valves in its regulations.

Rule of Law

Issue

Holding and Reasoning (Shabaz, J.)

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Healthcare Law

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