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

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

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