government证据等级 A独立来源
证据页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
访问于 2026年9月20日更新 2026年9月20日
原始来源
https://www.fda.gov/media/89920/download
fda.gov
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| 证据等级 | A · 政府·监管机构 |
| 独立来源 | 与对象无关的独立来源 |
| 来源 | government |
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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