The FDA's 2023 Revision to Blood Donation Criteria

The FDA's final guidance, Recommended Criteria for Donor Questioning, Deferral, or Requalification to Reduce the Risk of Transfusion-Transmitted Human Immunodeficiency Virus ↗, issued 11 May 2023, superseded the agency's 2020 three-month deferral policy, which had itself followed the 2015 revision and the lifetime ban that preceded it. The 2015 guidance had required a twelve-month deferral for any man who reported having sex with another man; the 2023 guidance eliminated that category-based criterion entirely.

Under the revised framework, all prospective donors — regardless of sex or sexual orientation — are assessed through a standardised individual risk questionnaire. The operative change is that eligibility turns on specific sexual-behavior variables, chiefly whether a donor has had a new or multiple sexual partners in the preceding three months and, within that period, anal sex. Those criteria apply uniformly: a heterosexual man or woman who meets the defined risk profile is deferred on the same grounds as a gay or bisexual man who does. A gay or bisexual man whose answers fall outside the deferral indicators is eligible to donate.

The guidance document classifies this as a "deferral or requalification" standard under 21 C.F.R. Parts 606 and 630, the regulatory sections governing blood establishment registration and donor eligibility. The FDA grounded the revision in the finding that nucleic acid testing — which can detect HIV infection within about nine days of exposure — had narrowed the "window period" risk sufficiently to justify an individual-assessment rather than categorical approach. The agency also cited international evidence from Canada and the United Kingdom, both of which had moved to comparable individual-risk models before 2023.

The guidance took effect on the date of issuance and operates as the agency's current regulatory expectation ↗ on all registered blood establishments. It does not constitute rulemaking under the Administrative Procedure Act — FDA final guidances set out the agency's current thinking and create compliance expectations without amending the Code of Federal Regulations directly — but blood establishments that deviate from it bear the burden of demonstrating an alternative approach meets the regulatory safety standard.