ABC submitted joint comments to the FDA on the May 2022 “Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy” draft guidance, recommending that FDA not take regulatory action regarding pre-donation blood pressure (BP) and pulse requirements due to “the absence of data to support any correlation with risk to the donor.” The comments included requests to allow for the delegation of certain out-of-range BP and pulse assessments to qualified designees when the blood establishment maintains and follows established protocols as defined in approved SOPs without necessitating the consultation with the responsible physician.
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