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Tissue Donor Suitability Criteria To Precede GTPs Under Revised FDA Plan

This article was originally published in The Gray Sheet

Executive Summary

FDA will revise its plans for new risk-based tissue rulemaking by implementing donor suitability and good tissue practice (GTP) final rules concurrently, the agency says. However, the donor suitability final rule will be published first

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Tissue action plan

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...

Tissue action plan

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...

FDA Reasserts Dura Mater Device Status During Interim Preceding GTPs

FDA is moving forward with rules establishing human dura mater as a Class II medical device before the agency issues guidelines transitioning the product into the purview of tissue regulation

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