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MEMORANDUM

Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen Memorandum to All Registered Blood Establishments August 1995

Final
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This memorandum provides the recommendations of the Food and Drug Administration (FDA) on the implementation of donor screening tests for human immunodeficiency virus, type 1 (HIV-1)antigen(s).  The attached recommendations supersede previous FDA recommendations contained in a memorandum of October 4, 1989, following licensure of the first test for HIV-1 antigen(s).


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:

Dockets Management
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
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