The CBER is responsible for regulatory oversight of the U.S. blood supply. FDA develops and enforces standards for blood collection and for the manufacturing of blood products, including both transfusible components of whole blood and blood components. Also under the CBER’s jurisdiction are medical devices used to collect, process and store blood and blood products as well as diagnostic tests for blood borne infectious diseases (i.e. HIV, Hepatitis B).
FDA also inspects blood establishments and monitors reports of errors, accidents and adverse clinical events.
While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been. The role of FDA is to drive risk to the lowest level reasonably achievable without unduly decreasing the availability of this life saving resource.
Blood Proposed and Final Rules:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ActsRulesRegulations/BloodProposedFinalRules/default.htm
Blood Guidance:
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/default.htm
Further information on Blood and Blood Products is available at the following:
http://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/default.htm
