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Heart valve allograft litigation

This article was originally published in The Gray Sheet

Executive Summary

Remanded to the U.S. District Court for the Northern District of Illinois in a July 27 opinion of the Seventh Circuit Court of Appeals. At issue is whether FDA "promulgated a back door amendment" to replacement heart valve regulations, thereby denying the plaintiffs, Northwest Tissue Center and Oregon Tissue Bank, "the right to notice and comment on the regulation of allografts." In 1991, the agency issued a notice of applicability of a final rule (NAFR) stating that heart valve allografts are subject to replacement heart valve regs, including a 1987 call for premarket approval applications for the devices. Previously, according to the tissue banks, FDA indicated that despite its "authority over processors of human source valves," it would not exercise that authority. The appeals court upheld the district court's dismissal of two other issues in the litigation ("The Gray Sheet" Nov. 16, In Brief).

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