- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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).
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-2013-S-0610.