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GUIDANCE DOCUMENT

Screening and Testing of Donors of Human Tissue Intended for Transplantation Guidance for Industry July 1997

Final

Screening and Testing of Donors of Human Tissue Intended for Transplantation

Docket Number:
93N-0453
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance document represents FDA's current thinking on screening and testing of donors of human tissue intended for transplantation. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. Written requests for single copies of this document may be submitted to the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. The document may also be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX- or 301-827-3844. Persons with access to the INTERNET may obtain the document using the World Wide Web (WWW) or bounce-back e-mail. For WWW access, connect to CBER at http://www.fda.gov/cber/publications.htm.


Submit Comments

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:

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

All written comments should be identified with this document's docket number: 93N-0453.

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