Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency or we) is announcing the availability of a draft guidance for industry #254 entitled "Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products." FDA's Center for Veterinary Medicine (CVM) is issuing this guidance 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), which meet the definition of new animal drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Donor eligibility is a critical component of current good manufacturing practices (CGMPs) 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.