Direct Links to important GMP Blood Product Guidelines
FDA Guidance for Industry Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors
FDA Compliance Program Guidance Manual Chapter 42 - Blood and Blood Products Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors- 7342.001
FDA Compliance Program Guidance Manual Chapter 42 – Blood and Blood Products Inspection of Source Plasma Establishments, Brokers, Testing Laboratories, and Contractors - 7342.002
Compliance Program Guidance Manual Chapter – 42 Blood and Blood Products Inspection of Licensed In-Vitro Diagnostic (IVD) Devices 7342.008
FDA FEDERAL REGISTER Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
FDA Guidance for Industry Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container
FDA FEDERAL REGISTER Medical Devices; Hematology and Pathology Devices; Classification of Cord Blood Processing System and Storage Container
Investigational New Drug Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System
FDA 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)
FDA Guidance for Industry Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens
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