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November 2022 FDA Regulations HCT/Ps: Summary

INTRODUCTION, Page 1, Paragraph 3 In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should be in Agency guidances means that something is suggested or recommended, but not required.

II QUESTIONS AND ANSWERS A. 1. Paragraph 1 HCT/Ps that meet all of the criteria in 21 CFR 1271.10(a) are subject only to regulation undersection 361 of the Public Service Act (PHS Act) and the regulations in 21 CFR Part 1271. AnHCT/P that falls into this category is sometimes referred to as a "361 HCT/P" and no premarket authorization is required.

A. 2. Paragraph 1 To further assist HCT/P manufacturers, FDA issued the Guidance for Industry, "Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use", dated November 2017 and updated July 2020.

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