ABC also submitted joint comments on the “Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements” draft guidance. ABC expressed support for the policy that allows for the release of blood components collected following an inadvertent failure to follow procedures for obtaining donor blood pressure, pulse, weight, or confirming donation frequency, pregnancy history or red blood cell loss. We recommended, however that FDA allow for the review and monitoring of error rates and corrective actions by FDA investigators during the routine inspection process, as opposed to the proposed requirement to report annually the number and type of donations released under the conditions of the draft guidance.
