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GUIDANCE DOCUMENT

Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens Guidance for Industry June 2000

Final

Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens

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

The purpose of this guidance document is to inform all establishments or persons engaged in the testing of donations of human tissue intended for transplantation and regulated under 21 CFR Part 1270 of the availability of two licensed donor screening tests labeled for use with cadaveric (post-mortem) blood specimens.


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