CFR section
21 CFR 1271.80(b): What are the general requirements for donor testing?
PART 1271-HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS · Subpart C-Donor Eligibility
Key facts
| Citation | 21 CFR 1271.80(b) |
|---|---|
| Section | What are the general requirements for donor testing? |
| 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, Drugs, Other_Regulations |
| Regulation text (excerpt) | (b) Timing of specimen collection. You must collect the donor specimen for testing at the time of recovery of cells or tissue from the donor; or up to 7 days before or after recovery, except: (1) For donors of peripheral blood stem/progenitor cells, bone marrow (if not excepted under § 1271.3(d)(4)), or oocytes, you may collect the donor specimen for testing up to 30 days before recovery; or (2) In the case of a repeat semen donor from whom a specimen has already been collected and tested, and… |
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