[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1271.50]

[Page 725-726]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1271_HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED
PRODUCTS--Table of Contents
 
                       Subpart C_Donor Eligibility
 
Sec. 1271.50  How do I determine whether a donor is eligible?

    (a) Determination based on screening and testing. If you are the 
establishment responsible for making the donor-eligibility 
determination, you must determine whether a donor is eligible based upon 
the results of donor screening in accordance with Sec. 1271.75 and 
donor testing in accordance with Sec. Sec. 1271.80 and 1271.85. A 
responsible person, as defined in Sec. 1271.3(t), must determine and 
document the eligibility of a cell or tissue donor.
    (b) Eligible donor. A donor is eligible under these provisions only 
if:
    (1) Donor screening in accordance with Sec. 1271.75 indicates that 
the donor:
    (i) Is free from risk factors for, and clinical evidence of, 
infection due to relevant communicable disease agents and diseases; and

[[Page 726]]

    (ii) Is free from communicable disease risks associated with 
xenotransplantation; and
    (2) The results of donor testing for relevant communicable disease 
agents in accordance with Sec. Sec. 1271.80 and 1271.85 are negative or 
nonreactive, except as provided in Sec. 1271.80(d)(1).