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FDA Guidance for Industry Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors Who Were Tested For Communicable Diseases Using Pooled Specimens or Diagnostic Tests


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
This guidance provides you, an establishment1 that makes donor eligibility determinations for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the donor eligibility and additional requirements under Title 21 Code of Federal Regulations, Part 1271, Subpart C (21 CFR Part 1271, Subpart C).

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