- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter 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This draft guidance is for sponsors, firms, individuals, and establishments that participate in the manufacture of, or perform any aspect of the donor eligibility determination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.
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-2021-D-0401.