Skin Substitutes for Treating Chronic Wounds: Q&A with the Agency for Healthcare Research and Quality from us fda cfr 21 Watch Video
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Description: Disclaimer nA skin substitute’s commercial availability is not a reflection of its legal status. Manufacturers self-determine whether their human cells, tissues, or cellular or tissue-based product (HCT/P) can be marketed without FDA preapproval and often misunderstand or mischaracterize the criteria they must meet for the product to be regulated solely for communicable disease risk. See 21 CFR 1271.10(a). For more information, see “FDA Announces Comprehensive Regenerative Medicine Policy Fr
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