CFR section
21 CFR 630.10(g)(2)(ii): General donor eligibility requirements
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 630.10(g)(2)(ii) |
|---|---|
| Section | General donor eligibility requirements |
| 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) | (ii) The donor acknowledgement must not include any exculpatory language through which the donor is made to waive or appear to waive any of the donor's legal rights. It must, at a minimum clearly address the following: (A) The donor has reviewed the educational material provided under paragraph (b) of this section regarding relevant transfusion-transmitted infections; (B) The donor agrees not to donate if the donation could result in a potential risk to recipients as described in the educational… |
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