CFR section

21 CFR 1271.75(e): How do I screen a donor?

PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility

Key facts

Citation 21 CFR 1271.75(e)
Section How do I screen a donor?
Part PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart Subpart C-Donor Eligibility
Subchapter 21 CFR L Other
Product types cited Biologics, Other_Regulations
Regulation text (excerpt) (e) Abbreviated procedure for repeat donors. If you have performed a complete donor screening procedure on a living donor within the previous 6 months, you may use an abbreviated donor screening procedure on repeat donations. The abbreviated procedure must determine and document any changes in the donor's medical history since the previous donation that would make the donor ineligible, including relevant social behavior.

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