U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday
  1. Regulatory Information

GUIDANCE DOCUMENT

Requalification of Donors Previously Deferred for a History of Viral Hepatitis after the 11th Birthday Guidance for Industry September 2017

Final

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

Issued by:
Guidance Issuing Office
Center 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).


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010