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
ecommendations 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
FDA FEDERAL REGISTER Blood Vessels Recovered With Organs and Intended for Use in Organ Transplantation
The purpose of
this final rule is to amend the
regulations so that blood vessels
recovered with organs and intended for
use in organ transplantation, and
labeled as such, are governed by the
regulations pertaining to organs.
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
This guidance document provides recommendations for the submission of a biologics license application (BLA) (21 CFR Part 601) for placental/umbilical cord blood products that are:
manipulated minimally; and
intended for hematopoietic reconstitution in patients with hematological malignancies; and
intended to be used in recipients unrelated to the donor.
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)
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)