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July 21, 2022

ABC Submits Joint Comments on Hold Requirements

By America's Blood Centers

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Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements” draft guidance.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to the proposed requirement to report annually the number and type of donations released under the conditions of the draft guidance. 

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  • About
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    • Foundation
    • ADRP
  • Advocacy
    • 2023 Advocacy Agenda
    • Our Priorities
      • Strengthening the Blood Supply
      • Expanding Access to Blood Products
      • Moving Toward an Individual Donor Assessment
      • Diversifying the Donor Base
      • Eliminating Unnecessary and Duplicative Testing Requirements
      • Lowering the U.S. Platelet Content Requirement
      • Updating vCJD Guidance
      • Expanding the Availability of Blood in Hospice
    • Letters and Comments
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