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Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception – Guidance for Industry

U.S. Food and Drug Administration

accessed Sep 18, 2026Updated Sep 19, 2026
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https://www.fda.gov/media/89920/download

fda.gov

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Cited by (2)

FactAutologous Fat Grafting: US regulatory status (FDA) = Fat removed and reimplanted in the same person during the same surgical procedure may qualify for the 21 CFR 1271.15(b) exception if processing is limited to rinsing, cleansing, sizing and shaping (FDA final guidance, November 2017)FactAutologous Fat Grafting: Processed adipose cell products (US) = The FDA considers processing that isolates cellular components from fat, such as enzymatic digestion, to go beyond the same surgical procedure exception