Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests Guidance for Industry April 2008

GUIDANCE DOCUMENT

• Docket Number: FDA-2007-D-0070
• Issued by: Center for Biologics Evaluation and Research

This guidance provides you, an establishment1 that makes donor eligibility determinations for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the donor eligibility and additional requirements under Title 21 Code of Federal Regulations, Part 1271, Subpart C (21 CFR Part 1271, Subpart C). This guidance updates and replaces the January 2007 guidance of the same title to clarify that for the purposes of this guidance the term “certain HCT/Ps” also includes certain donor lymphocytes for infusion (DLIs), namely those lymphocytes for infusion collected from the same donor as hematopoietic progenitor/stem cells (HPCs); • provide updated recommendations regarding donor testing2 using pooled specimens of HPCs and DLIs (as specified above) due to the approval of Biologics License Application (BLA) supplements from two nucleic acid test manufacturers (see footnotes 5 through 7); and • specify that this guidance applies to certain HCT/Ps recovered from donors beginning on or after May 25, 2005 through February 23, 2007.

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