(DOWNLOAD) "Alabama Tissue Center of University of Alabama Health Service Foundation, P.C. v. Sullivan" by United States Court of Appeals for the Seventh Circuit # Book PDF Kindle ePub Free

July 27, 2021

eBook details

Title: Alabama Tissue Center of University of Alabama Health Service Foundation, P.C. v. Sullivan
Author : United States Court of Appeals for the Seventh Circuit
Release Date : January 16, 1992
Genre: Law,Books,Professional & Technical,
Pages : * pages
Size : 80 KB

Description

SHABAZ, District Judge. Six not-for-profit heart valve allograft processors filed a petition for review with this Court contesting the ""Notice of Applicability of a Final Rule"" (""NAFR"") published by the Food and Drug Administration (""FDA"") on June 26, 1991 at 56 Federal Register 29,177. The NAFR states that replacement heart valve allografts are subject to the final rule issued by the FDA on May 13, 1987, which requires the filing of a premarket approval application (""PMA"") for all preamendment replacement heart valves and their equivalents. A heart valve allograft is a human heart valve which has been processed and preserved so it can be stored until needed for implantation into a human recipient. Because we conclude that we lack jurisdiction to entertain the petition for review of the NAFR, we dismiss the petition. BACKGROUND