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Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

U.S. Food and Drug Administration

访问于 2026年9月20日更新 2026年9月20日
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https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulatory-considerations-human-cells-tissues-and-cellular-and-tissue-based-products-minimal

fda.gov

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引用页面 (11)

FactAdipose Tissue: Governing FDA guidance = 'Regulatory Considerations for HCT/Ps: Minimal Manipulation and Homologous Use' (21 CFR 1271.10(a)); July 2020 version, superseding the Nov/Dec 2017 guidanceFactSVF-assisted Fat Grafting: Applicable US FDA guidance = Final guidance 'Regulatory Considerations for HCT/Ps: Minimal Manipulation and Homologous Use', July 2020 (supersedes November 2017 version)FactSVF Facial Fat Grafting: Applicable FDA guidance = Regulatory Considerations for HCT/Ps: Minimal Manipulation and Homologous Use (docket FDA-2017-D-6146)AnswerSVF 지방이식은 국내에서 첨단재생의료에 해당하나요? 세포처리시설 인증을 확인해야 하나요?Answer워터젯 방식으로 지방을 뽑아도 SVF 효과가 같나요? 효소로 분리하는 것과 기계로 분리하는 것은 다른가요?AnswerSVFの分離は酵素（コラゲナーゼ）と機械式でどう違い、国によって規制の扱いは変わりますか？Answer渡韓してSVF脂肪注入を受ける前に何を確認し、帰国後の経過はどう見ればよいですか？Answerقبل السفر الى كوريا لاجراء العملية، ما الاسئلة التي يجب ان اطرحها على العيادة؟Answer干细胞丰胸、干细胞脂肪填充是不是智商税？SVF到底是什么东西？Answer赴韩做SVF脂肪移植，报价单和中介费应该怎么核对？Answer为什么要去韩国做？国内的监管是怎么规定的，胶原酶分离在法规上有什么争议？