Tissue Guidances, Rules and Related Documents
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Documents are Organized by Category:
- General
- Registration and Listing
- Donor Eligibility
- Current Good Tissue Practices
- Reporting
- Medical Devices
- Hematopoietic Stem Cells
- Compliance/Inspection
- Related Information
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General
- Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide - 8/24/2007
- Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage - 7/6/2007
- FEDERAL REGISTER: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Final Rule - 3/12/2007
- Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update - 9/2006
- Draft Guidance for Reviewers: Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs) - 8/15/2003
- Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation - 3/8/2002
- Human Cells or Tissues Intended for Transplant Into a Human Recipient That Have Ex-vivo Contact With Live Nonhuman Animal Cells, Tissues, or Organs Letter - 3/8/2002
- Information and Recommendations for Physicians Involved in the Co-Culture of Human Embryos with NonHuman Animal Cells
- Office of Inspector General - January 2001 Report: Informed Consent in Tissue Donation, Expectations and Realities (PDF, 158 KB)
- Office of Inspector General - January 2001 Report: Oversight of Tissue Banking (PDF, 111 KB)
- FEDERAL REGISTER Human Tissue Intended for Transplantation; Final Rule - 7/29/1997
- Proposed Approach to Regulation of Cellular and Tissue-Based Products - 2/28/1997
- Reinventing the Regulation of Human Tissue - 2/1997
Tables for Proposed New Regulatory Framework (PDF, 215 KB) - FEDERAL REGISTER Application of Current Statutory Authorities to Human Somatic Cell Therapy Products and Gene Therapy Products; Notice - 10/14/1993 (PDF, 489 KB)
Registration and Listing
- FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Correction - 1/30/2004
- FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Opportunity for Public Comment
- FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final rule; delay of effective date - 1/21/2003
- FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final Rule - 1/19/2001
Donor Eligibility
- 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: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products - 8/8/2007
- FEDERAL REGISTER: Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling; Final Rule - 6/19/2007
- FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction - 3/24/2006
- FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule - 5/25/2004
- FDA Finalizes New Rule on Donor Eligibility for Human Tissues and Cells - 5/20/2004
- 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: 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 - 7/29/1997
Current Good Tissue Practices
- Draft 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) - 1/16/2009
- Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements - 9/8/2006
- FEDERAL REGISTER Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement; Final Rule - 11/24/2004
- FDA Improves the Safety of Human Cells and Tissues by Finalizing New Rules for "Good Tissue Practice" - 11/18/2004
- FDA Proposes New Rules for "Good Tissue Practice" - 1/5/2001
Reporting
- 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
- SOPP 8508 - Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based
Medical Devices
- Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs) - 7/23/2007
- Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container - 1/31/2007
- FEDERAL REGISTER: Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container; Final Rule - 1/31/2007
Hematopoietic Stem Cells
- Draft Guidance for Industry: Minimally Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic Reconstitution in Patients with Hematological Malignancies - 1/16/2007
- Request for Proposed Standards for Unrelated Allogeneic Peripheral and Placental/Umbilical Cord Blood Hematopoietic Stem/Progenitor Cell Products; Request for Comments - 1/20/1998
Compliance/Inspection
- FDA Issues Guidance to Tissue Establishments - 9/13/2006
Related Information
- 21 CFR Part 1270 - Human Tissue Intended for Transplantation
- 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products
- Assisted Reproductive Technology - Center for Disease Control and Prevention (CDC)
- International Tissue Initiatives - World Health Organization (WHO)
- Products (HCT/Ps)
- Other Document Listings