REGULATORY UPDATE: FDA Issues Three Guidance Documents

On Monday, the Food and Drug Administration issued one final guidance for immediate implementation and two draft guidance documents. AABB is pleased to see the agency’s evidence-based response to feedback from AABB and others in the blood community. 

The final guidance, Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components, supersedes the April 2020 guidance and updated August 2020 guidance of the same title. The most notable change is FDA’s decision to remove all prior recommendations to indefinitely defer blood donors based on geography-related risk factors. 

FDA continues to require the following:

• Individuals who volunteer that they received cadaveric pituitary hGH should be permanently deferred.
• Donors who have one or more blood relatives with familial prion disease (e.g., familial CJD, Gerstmann-Sträussler-Scheinker disease, or fatal familial insomnia) are not eligible for requalification under 21 CFR 630.35(b). No donor screening question is required.
• Defer donors who receive human cadaveric dura mater allografts because such transplantation is still performed in the U.S. and presents a remote risk of iatrogenic CJD.

FDA also issued a new draft guidance, Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements, in response to numerous requests to retain the recommendations issued in the April 2020 Alternative Procedures Guidance. The draft guidance removes the requirement to discard a donation due to an inadvertent failure to meet requirements for donor blood pressure, pulse, weight, donation frequency for whole blood and red blood cells collected by apheresis, pregnancy and red blood cell loss for plasma collected by plasmapheresis. 

The draft guidance states that FDA does not intend to take regulatory action regarding the release of blood components collected from certain ineligible blood donors if the collection meets all other donation requirements under the following circumstances: 

• An error that occurred during the donor eligibility determination is discovered post-donation, and such error resulted in a blood establishment incorrectly determining that a donor met the eligibility criteria. 
• A blood collection facility receives post-donation information for a donor with respect to these requirements, and such information would have resulted in that donor being determined to be ineligible during the facility's evaluation of the criteria.

In addition, FDA does not intend to take regulatory action if source plasma is released after a quarantine hold of 45 calendar days instead of 60 calendar days (21 CFR 640.69(f)).

In the additional draft guidance, Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy, FDA addresses feedback regarding donor eligibility requirements for blood pressure and pulse in 21 CFR 630.10 and medical supervision in 21 CFR 630.5. The draft guidance states that FDA agrees with the feedback and updates recommendations to reflect that physicians may make the medical determination by telephonic or other offsite consultation that the donation will not adversely affect the health of the donor.

Furthermore, FDA states that donor health can be adequately protected when “individuals with pulse measurements below 50 beats per minute who report being healthy athletes are considered eligible without consultation with the responsible physician” and when “individuals with an irregular pulse are considered eligible without consultation with the responsible physician.”

AABB is evaluating each guidance in greater detail to provide comprehensive overviews and resources to support implementation. AABB is also preparing comments to the docket. Member centers may contact regulatory@aabb.org with comments and questions.