Establishment that manufactures human cells, tissues
Establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service (PHS) Act are required to register and list their HCT/Ps with the Food and Drug Administration (FDA) pursuant to 21 CFR part 1271. Establishments must register and list their HCT/Ps within 5 days of beginning operation, and registration must be updated annually in December. We can assist you in registering your establishment with FDA. Contact us for more information.