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GUIDANCE DOCUMENT

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Guidance for Industry August 2007

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
2004D-0193
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance to assist you, establishments making donor eligibility determinations, with complying with the requirements in Title 21 Code of Federal Regulations, part 1271, subpart C (21 CFR part 1271, subpart C) (Ref. 1). The regulations under 21 CFR part 1271, subpart C set out requirements for determining donor-eligibility, including donor screening and testing, for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).

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Submit Comments Online

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:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2004D-0193.

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