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Heart valve allografts

This article was originally published in The Gray Sheet

Executive Summary

Washington Legal Foundation files suit in the U.S. district court for the District of Columbia on March 4, seeking to enjoin FDA from enforcing its policy of requiring premarket approval applications for human heart valve allografts. WLF argues that the allografts do not fall within the definition of medical devices in the 1976 device law. In May, the group petitioned FDA to withdraw its June 1991 final rule requiring PMAs for the valves. That petition was denied on Feb. 8.
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