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# Donor Eligibility Guide for Animal Cell, Tissue Products
- URL: https://www.fdaweb.com/donor-eligibility-guide-for-animal-cell-tissue-products/
- Published: 2021-09-22T12:00:00.000Z
- Updated: 2026-09-14T17:15:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150193

*Federal Register* notice: FDA is announcing the availability of a draft guidance for industry #254 entitled *Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products*. The document emphasizes that donor eligibility is a critical component of current good manufacturing practices when manufacturing such products. It says a donor should be considered eligible only if donor screening 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. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-20517.pdf?ref=fdaweb.com).