Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday Guidance for Industry September 2017
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Biologics Evaluation and Research
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).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2017-D-5152.