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[104] If an HCT/P does not meet the criteria set out in 21 CFR 1271.10(a), and the establishment that manufactures the HCT/P does not qualify for any of the exceptions in 21 CFR 1271.15, the HCT/P will be regulated as a drug, device, and/or biological product under the FD&C Act, and/or section 351 of the PHS Act (42 U.S.C

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[DOI] [PMC free article] [PubMed] [Google Scholar] 153.Niu Y., Chen K.C., He T., Yu W., Huang S., Xu K