Devices Regulated by CBER
Jursidiction of medical device review by the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) is governed by the FDA Intercenter Agreeement between CBER and CDRH (October 31, 1991).
CBER regulates medical devices related to licensed blood and cellular products by applying appropriate medical device laws and regulations. The medical devices regulated by CBER are intimately associated with the blood collection and processing procedures as well as the cellular therapies regulated by CBER. CBER has developed specific expertise in blood, blood products and cellular therapies and the integral association of certain medical devices with those biological products supports the regulation of those devices by CBER.
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications - 8/7/2008
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications - 11/9/2007
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications - 8/24/2007
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications - 3/15/2007
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications - 6/3/2005
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications - 6/30/2004
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications - 5/27/2004
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications - 1/6/2004
- Medical Devices Regulated by the Center for Biologics Evaluation and Research; List of Premarket Approval Actions - 3/31/2000
Devices
(Listed by the Office and Division responsible for the device.)
Office of Blood Research and Review
Division of Blood Applications
All Pending/Cleared/Approved OBRR Device Inquiries: Sayah Nedjar 301-827-3524
CODE CLASS DEVICE BSA III Warmer, blood, electromagnetic radiation BSB II Warmer, blood, non-electromagnetic radiation KZL II Blood and plasma warming devices GGK I Red cell lysing reagent (including elution reagents) KJA II Blood specimen collection devices-vacuum KSE II Blood storage refrigerators and freezers KSF II Quality control kits for blood banking reagents KSG II Potentiating media for in vitro diagnostic use KSI II Lectins and protectins KSK II Stabilized enzyme solutions KSL I Copper sulfate for specific gravity determination KSM II Automated Coombs test systems KSN II Automated cell-washing centrifuges for immunohematolgy KSO I & II Blood bank centrifuges for in vitro diagnostic use KSP I Cell-freezing apparatus and reagents (for in-vitro use) KSQ I Blood mixing and weighing devices MYJ II Blood mixing and weighing devices, semi-automated KSS I & II Blood bank supplies (including temperature monitors) KSX II Blood grouping substances of non-human origin KSY I Blood grouping view boxes KSZ II Automated blood grouping and antibody test systems MMH TBD Stand alone blood bank software MTQ II Software blood virus application (data management systems, not instrumentation) MTH II Tray,leukocyte typing (including qualitative HLA typing, non diagnostic) MTI II Kit,cell screening,fetal KST I Vacuum-assisted blood collection system MYX II Automated Vacuum-assisted blood collection system MYY I Semi-automated blood component separator KSH II Environmental chambers for the storage of platelet KSD I Heat sealing devices (crimpers) MZI II Qualitative Test for HLA, non-diagnostic MZH II Quantitative Test for HLA, non-diagnostic MYQ II Antibody Elution Kit MYW II Indicator, Irradiation, Blood ZZZ I & II & III Unclassified Office of Blood Research and Review
Division of Hematology
Non product related inquires only: Sayah Nedjar 301-827-3524
CODE CLASS DEVICE CAC III Fibrin Sealant Preparation Device CAC II Autotransfusion Device MZM II Fibrin Sealant Preparation Device CAK II Blood transfusion microfilters GKT II & III Automated blood cell separator MYO II Function Test for Platelet Products GKZ II Automated differential cell counter (including quantitative HLA tests) KSB II Transfer sets (including sterile docking devices) KSR II Empty containers for the collection and processing KSS I & II Blood bank supplies KSW II Processing system for frozen blood MTM II Reagent, thrombin MYP II Platelet Antibody Test MYS II Automated Cryoprecipitated AHF Device MZB II Blood Irradiator MZC II Bacterial Detection Systems for Platelet Transfusion Products MZG II Test for Residual WBC in Leukoreduced Blood Components Office of Blood Research and Review
Division of Transfusion Transmitted Diseases
Non product related inquires only: Sayah Nedjar 301-827-3524
CODE CLASS DEVICE KSF II Quality control kit for blood banking reagents (including viral marker controls for donor screens MTK II Kit, sample collection,HIV MTL III Test, monitor, HIV (MTN)MYR II Test, syphilis,Treponemal (for Donor Testing) MTO II Software,management microplate assay MTP TBD Antibody to HTLV-1, ELISA LOM III Hepatitis, hepatitis B test, (anti-HBc IgM) LFZ II Cytomegalovirus, enzyme linked immunoabsorbant assay (including donor screens) MVZ III HIV Testing Service MYZ II Quality control kit for bloodborne pathogen testing of donors MZA II Automated Bloodborne Pathogen Test Equipment MYE II CMC Test for Donors MZC II Bacterial Detection Systems for Platelet Transfusion Products MZF III HIV Testing Service Office of Cellular, Tissues, and Gene Therapies
Division of Cellular and Gene Therapies
All Pending/Cleared/Approved OCTGT Device Inquiries: Deb Lavoie 301-827-5102
CODE CLASS DEVICE GKZ II Automated differential cell counter KSR II Empty containers for the collection and processing LWE II Kit, bone marrow collection MTR II Progenitor cell enumeration MYK II Cord Blood Collection Kit MZJ III Stem Cell Concentration System MZK III Stem Cell Separation System OAO II Cord Blood Processing System and Storage Container Office of Vaccines Research and Review
Division of Vaccines and Related Products Applications
All Pending/Cleared/Approved OVRR Device Inquiries: Paul Richman, Ph.D. 301-827-3070
CODE CLASS DEVICE MTS II Challenge Vials, Endotoxin MZL II Quality Control Kit for Endotoxin Test
Note: To process applications more efficiently, sponsors may voluntarily use a submission cover sheet found on CDRH's web site.