Tissue action plan
This article was originally published in The Gray Sheet
Executive Summary
FDA delays effective date to Jan. 21, 2004 for registration and listing of establishments engaging in the processing of all human cells, tissues and cellular and tissue-based products (HCT/Ps) not currently regulated. In a Federal Register notice slated for publication Jan. 21, FDA cites "numerous comments submitted" to the agency, concluding "that implementing the registration final rule under the staggered effective date for remaining HCT/Ps would be contrary to the public interest." CBER recently explained that the agency first intended to publish a donor suitability final rule before concurrently implementing it with GTP final rules (1"The Gray Sheet" Oct. 21, 2002, p. 26). FDA will continue to accept voluntary registrations...
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