FDA Reminds Labs that Cells and Tissues Must Get Nucleic Acid Testing

The U.S. Food and Drug Administration last week issued final guidance giving laboratories that test human cells, tissues and cellular and tissue-based products (HCT/Ps) 30 days to come into compliance with its requirements for the use of an FDA-licensed individual donor nucleic acid test (NAT), according to a newsletter from America’s Blood Centers. The agency [Sign in to read the full article...]