CFR section
21 CFR 640.21(g): Eligibility of donors
PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS · Subpart C-Platelets
Key facts
| Citation | 21 CFR 640.21(g) |
|---|---|
| Section | Eligibility of donors |
| Part | PART 640-ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS |
| Subpart | Subpart C-Platelets |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs |
| Regulation text (excerpt) | (g) The responsible physician must obtain the informed consent of a plateletpheresis donor on the first day of donation, and at subsequent intervals no longer than 1 year. (1) The responsible physician must explain the risks and hazards of the procedure to the donor; and (2) The explanation must be made in such a manner that the donor may give consent, and has a clear opportunity to refuse the procedure. |
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