FDA final guidance relaxes criteria for blood donors
Regulatory News | 11 May 2023 |
The US Food and Drug Administration (FDA) on Thursday issued final guidance intended to make it easier for gay and bisexual men and others to donate blood by doing away with previous time-based deferrals and screening questions, and instead relying on individual, risk-based questions to reduce the risk of HIV transmission.
“Based on our review of the available science as discussed below, we recommend eliminating the screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Instead, we recommend assessing donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor regardless of sex or gender,” FDA writes in the guidance.
Under the new policy, donors who report having a new sexual partner, more than one sexual partner in the past three months, or report having anal sex in the past three months, would be deferred to lessen the chance of individuals with new or recent HIV infection donating blood.
“Additionally, under these final recommendations, those taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)), will also be deferred,” FDA said.
The agency said that blood establishments can immediately implement the policy by updating their donor history questionnaires and procedures.
FDA said the policy is mean to “expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.”
The guidance supersedes an earlier policy issued in April 2020. The document is largely unchanged from a proposed guidance issued in January. (RELATED: FDA proposes easing blood donor requirements, Regulatory Focus 27 January 2023)
Changes from the draft version include a clarification that all donors, regardless of their sex or gender, will be asked the same screening questions with respect to HIV risk. The agency has also provided more information to explain why undetectable does not equal untransmissible for blood transfusion, and added a recommendation that individuals should not stop taking their prescribed medication in order to donate blood.
FDA said the new policy incorporates the best available scientific evidence and is in line with policies in place in the United Kingdom and Canada.
“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER).
FDA announcement
FDA final guidance
“Based on our review of the available science as discussed below, we recommend eliminating the screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Instead, we recommend assessing donor eligibility using the same individual risk-based questions relevant to HIV risk for every donor regardless of sex or gender,” FDA writes in the guidance.
Under the new policy, donors who report having a new sexual partner, more than one sexual partner in the past three months, or report having anal sex in the past three months, would be deferred to lessen the chance of individuals with new or recent HIV infection donating blood.
“Additionally, under these final recommendations, those taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)), will also be deferred,” FDA said.
The agency said that blood establishments can immediately implement the policy by updating their donor history questionnaires and procedures.
FDA said the policy is mean to “expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.”
The guidance supersedes an earlier policy issued in April 2020. The document is largely unchanged from a proposed guidance issued in January. (RELATED: FDA proposes easing blood donor requirements, Regulatory Focus 27 January 2023)
Changes from the draft version include a clarification that all donors, regardless of their sex or gender, will be asked the same screening questions with respect to HIV risk. The agency has also provided more information to explain why undetectable does not equal untransmissible for blood transfusion, and added a recommendation that individuals should not stop taking their prescribed medication in order to donate blood.
FDA said the new policy incorporates the best available scientific evidence and is in line with policies in place in the United Kingdom and Canada.
“The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER).
FDA announcement
FDA final guidance
© 2025 Regulatory Affairs Professionals Society.
![Regulation of IVDs in the US and Major Markets Outside the US [5.0 RAC]](https://my.raps.org:443/images/20358f95-5c5a-46ba-be45-520f5f5a122c.img?resize=yes)
![Understanding and Managing the US Clinical Trial Process [4.0 RAC]](https://my.raps.org:443/images/cf57a50c-ddd0-432d-a213-e719552b0aec.img?resize=yes)
