- 2013. Food and Drug Administration. Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis). U.S. Department of Health and Human Services, Rockville, Maryland.
- 2013. Food and Drug Administration. Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). U.S. Department of Health and Human Services, Rockville, Maryland.
- 2011. 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). U.S. Department of Health and Human Services, Rockville, Maryland.
- 2011. Food and Drug Administration. Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2009. Food and Drug Administration. Draft Guidance for Industry: Use of Seriological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion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. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2008. Food and Drug Administration. Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). U.S. Department of Health and Human Services, Rockville, Maryland.
- 2008. Food and Drug Administration. Guidance for Industry: Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostics Tests. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2007. Food and Drug Administration. Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Small Entity Compliance Guide. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2007. Food and Drug Administration. Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2007. Food and Drug Administration. Guidance for Industry: Current Good Tissue Practice (CGTPs) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). U.S. Department of Health and Human Services, Rockville, Maryland.
- 2007. Food and Drug Administration. Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2006. Food and Drug Administration. Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2006. Food and Drug Administration. Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2005. Food and Drug Administration. Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). U.S. Department of Health and Human Services, Rockville, Maryland.
- 2004. Food and Drug Administration. Guidance for Industry: Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). U.S. Department of Health and Human Services, Rockville, Maryland.
- 2002. Food and Drug Administration. Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation. U.S. Department of Health and Human Services, Rockville, Maryland.
- 2000. Food and Drug Administration. Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens. U.S. Department of Health and Human Services, Rockville, Maryland.
- 1997. Food and Drug Administration. Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation. U.S. Department of Health and Human Services, Rockville, Maryland.
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