
Eligibility Determination for Donors of Human Cells, Tissues Form
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People also ask
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What is the FDA in 21 CFR 1271 subpart C?
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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What is donor eligibility?
You must be at least 17 years old to donate to the general blood supply, or 16 years old with parental/guardian consent, if allowed by state law. There is no upper age limit for blood donation as long as you are well with no restrictions or limitations to your activities.
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What are the laboratory tests for donors FDA eligibility?
Per FDA requirements, all HCT/P donors must be tested for the following infectious diseases: HIV, types 1 and 2; HBV; HCV; and Treponema pallidum.
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