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GUIDANCE DOCUMENT

Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy Guidance for Industry August 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2016-D-2071
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) intended solely for autologous use.  On May 22, 2015, in order to better assure the safety of the nation’s blood supply and to help protect donor health, FDA finalized its revision of the applicable requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture (Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use, 80 FR 29842 (donor eligibility rule)1).  The donor eligibility rule includes requirements related to current good manufacturing practice, donation testing, donor eligibility, and donation suitability (in 21 CFR Parts 606, 610, 630, and 640).  It became effective on May 23, 2016.2   

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All written comments should be identified with this document's docket number: FDA-2016-D-2071.

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