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Code of Federal Regulations

Subpart A

General Provisions

1271.1What are the purpose and scope of this part?1271.3How does FDA define important terms in this part?1271.10Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part, and if so what must I do?1271.15Are there any exceptions from the requirements of this part?1271.20If my HCT/P's do not meet the criteria in § 1271.10, and I do not qualify for any of the exceptions in § 1271.15, what regulations apply?