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Home » Guidance Issued for HCT/P Testing in Cadaveric Donors
Guidance Issued for HCT/P Testing in Cadaveric Donors
February 25, 2005
The FDA has issued a guidance document that informs certain medical device manufacturers about performing studies to support modifying the indication for use of communicable disease tests to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).