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Tissue registration

This article was originally published in The Gray Sheet

Executive Summary

Human cellular or tissue products manufacturers regulated under 21 CFR 1270 must register and list products by May unless President Bush decides to include the reg in his regulatory review plan, FDA says in Feb. 13 Q&As on the agency's Tissue Action Plan (21 CFR 1271), which is comprised of three regulations. On Jan. 18, the agency signed off on the registration rule (1"The Gray Sheet" Jan. 22, p. 10); FDA will rescind 21 CFR 1270 once it finalizes two remaining rules covering donor suitability and good tissue practice. Manufacturers of products not regulated under 21 CFR 1270; device manufacturers must register and list with revised Form 3356 by Jan. 21, 2003

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