CFR section
21 CFR 630.15(b)(2): Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis
PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE · Subpart B-Donor Eligibility Requirements
Key facts
| Citation | 21 CFR 630.15(b)(2) |
|---|---|
| Section | Donor eligibility requirements specific to Whole Blood, Red Blood Cells and Plasma collected by apheresis |
| Part | PART 630-REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURING USE |
| Subpart | Subpart B-Donor Eligibility Requirements |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics |
| Regulation text (excerpt) | (2) What requirements apply to obtaining informed consent ? (i) The responsible physician must obtain the informed consent of a plasma donor on the first day of donation or no more than 1 week before the first donation, and at subsequent intervals of no longer than 1 year. (ii) The responsible physician must obtain the informed consent of a plasma donor who does not return within 6 months of the last donation. (iii) The responsible physician must explain the risks and hazards of the procedure to… |
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