FDA - Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases
Recommendation
7/8 October 2025
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On 20 June, the U.S. Food and Drug Administartion has updated their page about "Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases". On this page the FDA gives an overview about:
- Licensed Donor Screening Tests
- Cleared Nucleic Acid Tests (NAT) for Chlamydia trachomatis and Neisseria gonorrhea
- Cleared Donor Screening Tests for Cytomegalovirus (CMV)
- Cleared Tests for Syphilis
Furthermore they refer to other relevant guidelines and documents:
Additional Resources
- Tissue Safety & Availability
- Tissue & Tissue Products
- Cellular & Gene Therapy Products
Information about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents and diseases under 1271.80:
- Testing HCT/P Donors: Specific Requirements
- Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (8/8/2007)
- Blood Donor Screening Tests
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