FDA 21 CFR 1271 Compliance for Exosome Material
What the regulation means for clinics and suppliers of MSC exosome material.
FDA 21 CFR Part 1271 establishes the regulatory framework for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) in the United States. For exosome suppliers operating in this framework, compliance means documented donor screening, tissue establishment registration, and traceability from donor to finished product.
Every B&H Bio batch meets 21 CFR 1271 requirements: donor screening for HIV, HBV, HCV, CMV, HTLV, syphilis, West Nile, Zika, and SARS-CoV-2. Documentation is included with every shipment.
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