Federal Register Notice: FDA is making available Guidance for Industry: 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. The document provides establishments with recommendations on the donor eligibility requirements from 21 CFR part 1271, subpart C, which became effective 5/25/05. The guidance applies only to certain HCT/Ps that were not regulated as HCT/Ps before 5/25/05, and that were recovered from donors beginning on or after the 5/25/05, and within 30 days of the date of publication of this document. To download this guidance, click here. To view this notice, click here.