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REFERENCES

Donor qualification requirements are located in 21 CFR 1271, Subpart C – Donor Eligibility.

Listed below are FDA final rules and guidance documents:

U.S. Department of Health and Human Services, Food and Drug Administration, Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule (69 FR 29785, May 25, 2004)

U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated August 2007.

U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O Infection, dated August 2009.

The Yellow Book, “Health Information for International Travel”, CDC. Includes information on malaria.

U.S. Department of Health and Human Services, Food and Drug Administration,

Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion and Human Cells, Tissues, and Cellular and Tissue-Based Products dated March 2009.

U.S. Department of Health and Human Services, Food and Drug Administration,

Draft Guidance for Industry and FDA Staff

Investigational New Drug Applications (INDs) for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications dated October 2009

U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution for Specified Indications dated October 2009.

U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) dated December 2011.

U.S. Department of Health and Human Services, Food and Drug Administration,

Guidance for Industry: Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products dated March 2016.

Additional references include:

AABB Standards for Cellular Therapy Product Services, current edition

FACT/JACIE International Standards for Cellular Therapy Product Collection, Processing & Administration, current edition

DHQ-HPC, Cord Blood UserInstApp_Ref v 1.2 eff. March 2016