Donors of peripheral blood for Reagent Red Blood Cells must meet all the criteria for donor eligibility under §§ 630.10 and 630.15 of this chapter .
21 CFR Part 660 · Additional Standards for Diagnostic Substances for Laboratory Tests
§ 660.31 Eligibility of donor
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
What FDA inspectors cite under § 660.31
Form FDA 483 observations citing this section, fiscal years 2009–2009 (Biologics).
- Same as for whole blood donor 1
Amendment history
Federal Register documents that created or amended this section.
- 80 FR 29906 22 May 2015