Subpart A. General Provisions

• § 1271.1 - What are the purpose and scope of this part?
• § 1271.3 - How does FDA define important terms in this part?
• § 1271.10 - Are 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?
• § 1271.15 - Are there any exceptions from the requirements of this part?
• § 1271.20 - If my HCT/P's do not meet the criteria in and I do not qualify for any of the exceptions in what regulations apply?