Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday: Guidance for Industry

Issue Date: September 1, 2017
Issued by: Center for Biologics Evaluation and Research
Topic(s): Blood, Blood Products
Status: Final

Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday: Guidance for Industry

We, FDA, are issuing this guidance to provide you, establishments that collect Whole Blood or blood components intended for transfusion or for further manufacture, including Source Plasma and Source Leukocytes, with recommendations for a requalification method under Title 21 of the Code of Federal Regulations (CFR) 630.35(b) (21 CFR 630.35(b)) for donors who had been indefinitely deferred for a history of viral hepatitis after the 11th birthday, prior to the elimination of the donor suitability requirement under 21 CFR 640.3(c)(1) and 21 CFR 640.63(c)(11).

Download the Guidance Document