Tissue Guidances

Tissue Guidances

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Tissue Guidance Documents

• 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). (PDF - 265KB)
  12/2011
• Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
  Updated: 3/2011
• Draft Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components for Transfusion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 3/2009
• Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for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) 4/25/2008
• 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 Diagnostic Tests 4/16/2008
• Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide 8/24/2007
• Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products 8/8/2007
• Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies 1/16/2007
• Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update 9/20/2006
• Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements 9/8/2006
• 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) 11/30/2005
• 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) 11/12/2004
• Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation 3/8/2002
• Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens 6/23/2000
• Guidance for Industry: Screening and Testing of Donors of Human Tissue Intended for Transplantation (PDF - 59KB)
  7/1997

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Withdrawals

Withdrawn - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells

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