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CVM GFI #254 Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products September 2021


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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: FDA-2021-D-0401

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This draft guidance is for sponsors, firms, individuals, and establishments that participate in the manufacture of, or perform any aspect of the donor eligibility determination for animal cells, tissues, and cell- and tissue-based products (ACTPs) that meet the definition of a new animal drug.   ACTPs that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or are intended to affect the structure or function of the animal generally meet the definition of a new animal drug.  All new animal drugs, including ACTPs, are required to be manufactured in accordance with Current Good Manufacturing Practices (CGMPs) to ensure that such drugs meet the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as to safety, and have the identity, strength, quality, and purity characteristics which they purport to or are represented to possess.   Donor eligibility is critical to ensuring safety and quality when manufacturing ACTPs.  A donor should be considered eligible to donate ACTPs only if screening of the donor shows that the donor is free from risk factors for, and clinical evidence of, infection with relevant disease agents and diseases, and the donor (and product/source material) test results for relevant disease agents are negative or nonreactive.   


Contact Point
Lynne Boxer
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-114
Rockville, MD 20855
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