CFR section

21 CFR 1271.75(c): 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(c)
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 Other_Regulations
Regulation text (excerpt) (c) Donors of reproductive cells or tissue. In addition to the relevant communicable disease agents and diseases for which screening is required under paragraphs (a) and (b) of this section, as applicable, and except as provided under § 1271.90, you must screen the donor of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for and clinical evidence of infection due to relevant communicable diseases of the genitourinary tract. Such screening must…

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