Donor Eligibility

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Regulations Under Certain Other Acts Administered by the Food and Drug Administration
  6. Human Cells, Tissues, and Cellular and Tissue-Based Products
  7. Donor Eligibility

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Section
1271.45

What requirements does this subpart contain?

Section
1271.47

What procedures must I establish and maintain?

Section
1271.50

How do I determine whether a donor is eligible?

Section
1271.55

What records must accompany an HCT/P after the donor-eligibility determination is complete; and what records must I retain?

Section
1271.60

What quarantine and other requirements apply before the donor-eligibility determination is complete?

Section
1271.65

How do I store an HCT/P from a donor determined to be ineligible, and what uses of the HCT/P are not prohibited?

Section
1271.75

How do I screen a donor?

Section
1271.80

What are the general requirements for donor testing?

Section
1271.85

What donor testing is required for different types of cells and tissues?

Section
1271.90

Are there other exceptions and what labeling requirements apply?