21 CFR 630.35
§ 630.35 Requalification of previously deferred donors.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 630.35, § 630.35 Requalification of previously deferred donors, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88457
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Full text
Establishments may determine a deferred donor to be eligible as a donor of blood and blood components if, at the time of the current collection, the donor meets the eligibility criteria in this part, except for the record of the previous deferral, and you determine that the criteria that were the basis for the previous deferral are no longer applicable. Criteria for the previous deferral are no longer applicable if the following conditions are met:
(a) The previous deferral was for a defined period of time and that time period has passed, or the deferral was otherwise temporary, such as a deferral based on eligibility criteria described in §§ 630.10(f)(1) through (5) or 630.15(b)(4); or
(b) For a donor deferred for reasons other than under § 610.41(a) of this chapter, you determine that the donor has met criteria for requalification by a method or process found acceptable for such purpose by FDA.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.