The FDA requires each establishment to register, submit and update a list of every HCT/P where collection, donor screening, donor testing, processing, storage, labeling, packaging, and distribution are performed. These requirements are described in 21 CFR 1271 Subpart B. Establishments must register and submit HCT/P lists using Form FDA 3356 which must be updated annually in December. Electronic registration also is available. Search for a registered HCT/P establishment using FDA's public query.
REGULATORY UPDATE: CBER Seeks Feedback on Opportunities to Advance CGT Development
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Wales to Expand Cell and Tissue Donor Eligibility for MSM
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