Tissue Guidances, Rules and Related Documents
Get e-mail updates when this information changes.
2007 | 2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 | 1998 | 1997 | 1995 | 1993
Related Documents
- Compliance Programs
- FDA Form 3356 - Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue Based-Products (HCT/Ps)
- SOPP 8508 - Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
- 21 CFR Part 1270 - Human Tissue Intended for Transplantation - 4/1/2008
- 21 CFR Part 1271 - Human Cells, Tissues, and Cellular and Tissue-Based Products - 4/1/2008
- Human Cell Products
- Human Cell and Tissue Device Products
- Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) - Registered Establishments
- International Tissue Initiatives - World Health Organization (WHO)
- Assisted Reproductive Technology - Center for Disease Control and Prevention (CDC) - Reproductive Cells and Tissue
- Xenotransplantation Products
Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.
Guidances and Rules
2008
- Draft Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for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
2007
- 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- Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs) - 7/23/2007
- Draft Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage - 7/6/2007
- 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: Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Final Rule - 3/12/2007
- 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
- Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update - 9/2006
- Guidance for Industry: Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements - 9/8/2006
- FDA Issues Guidance to Tissue Establishments - 9/13/2006
-
FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Correction - 3/24/2006 -
(PDF, 51 KB)
-
FEDERAL REGISTER Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule - 5/25/2004 - (PDF, 331 KB)
- FDA Finalizes New Rule on Donor Eligibility for Human Tissues and Cells - 5/20/2004
-
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 - (PDF, 405 KB)
- FDA Improves the Safety of Human Cells and Tissues by Finalizing New Rules for "Good Tissue Practice" - 11/18/2004
- 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 - (PDF, 34 KB)
- FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Correction - 1/30/2004 - (PDF, 40 KB)
- FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Interim Final Rule; Opportunity for Public Comment - 1/23/2004 - (PDF, 46 KB)
FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final rule; delay of effective date - 1/21/2003 - (PDF, 55 KB)
-
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 - (PDF, 106 KB)
- FEDERAL REGISTER Combination Products Containing Live Cellular Components; Public Hearing - 5/15/2002 (PDF, 46 KB)
- Guidance for Industry: Validation of Procedures for Processing of Human Tissues Intended for Transplantation - 3/8/2002 - (PDF, 16 KB)
- 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 - (PDF, 227 KB)
- Information and Recommendations for Physicians Involved in the Co-Culture of Human Embryos with NonHuman Animal Cells
- Draft Guidance for Industry: Precautionary Measures to Reduce the Possible Risk of Transmission of Zoonoses by Blood and Blood Products from Xenotransplantation Product Recipients and Their Intimate Contacts - 2/1/2002 - (PDF, 35 KB)
- FEDERAL REGISTER Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Final Rule - 1/19/2001- (PDF, 152 KB)
- Letter to National Governors Association on " Current Good Tissue Practice for Manufacturers of Human Cellular and Tissue-Based Products; Inspection and Enforcement - 1/19/2001 - (PDF, 30 KB)
- FDA Proposes New Rules for "Good Tissue Practice" - 1/5/2001
- 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)
- Human Bone Allograft: Manipulation and Homologous USe in Spine and Other Orthopedic Reconstruction and Repair; Public Meeting: Reopening of Comment Period - 12/13/2000 - (PDF, 124 KB)
- Guidance for Industry: Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens - 6/23/2000 - (PDF, 11 KB)
- Guidance for Industry - Screening and Testing of Donors of Human Tissue Intended for Transplantation - 7/29/1997 - (PDF, 34 KB)
- FEDERAL REGISTER Human Tissue Intended for Transplantation; Final Rule - 7/29/1997 - (PDF, 111 KB)
- Proposed Approach to Regulation of Cellular and Tissue-Based Products - 2/28/1997 - (PDF, 434 KB)
- Reinventing the Regulation of Human Tissue - 2/1997 - Tables
- FEDERAL REGISTER Notice Public Hearing: Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Implantation for Structural Repair or Reconstruction - 7/18/1995 - (PDF, 25 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)