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Relayed this comment blinded to FDA as demonstrating confusion in the profession because FDA Guidance for HCT/P donor eligibility is not harmonized with the PHS Guideline for organ donors. It would be confusing to AATB membership to add this language because FDA has not adopted the PHS Guidelines and tissue bankers cannot substitute it. Standards to reflect increased risk Unfortunately the PHS Guideline and language cannot be applied to HCT/P donor risk determinations. Wording is acceptable...
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