Food and Drug Administration - March 7, 2007
FDA has issued final guidance, entitled "Guidance for Industry:
Eligibility Determination for Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps)," to assist
establishments making donor eligibility determinations to comply
with the requirements for determining donor-eligibility,
including donor screening and testing for donors of human cells,
tissues, and cellular and tissue-based products. (for
background, see http://www.fda.gov/oashi/aids/listserve/listserve2004.html#screen)
The guidance applies to cells and tissues procured on or after
the effective date of the regulations contained in 21 CFR part
1271, subpart C (effective date May 25, 2005). It does not
replace the guidance concerning 21 CFR part 1270, entitled
"Guidance for Industry: Screening and Testing of Donors of Human
Tissue Intended for Transplantation," which remains applicable to
tissues recovered before May 25, 2005, and subject to 21 CFR part
1270.
The document provides guidance on donor-eligibility
determination, donor screenings, donor testing requirements
(including HIV), additional screening and testing requirements
for reproductive cells and tissues, and exceptions from the
requirements for determining donor-eligibility, and special
circumstances.
You can find the complete guidance document on the FDA web site
at http://www.fda.gov/cber/gdlns/tissdonor.htm
Richard Klein | HIV/AIDS Program Director | Food and Drug
Administration