FDA - Testing HCT/P Donors for Relevant Communicable Disease Agents and Diseases

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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