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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Devices Regulated by the Center for Biologics Evaluation and Research

Jurisdiction 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 Agreement 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.

Federal Register Notices related to Devices Regulated by CBER are at the bottom of this page.


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

CODECLASSDEVICE
BSAIIIWarmer, blood, electromagnetic radiation
BSBIIWarmer, blood, non-electromagnetic radiation
KZLIIBlood and plasma warming devices
GGKIRed cell lysing reagent (including elution reagents)
KJAIIBlood specimen collection devices-vacuum
KSEIIBlood storage refrigerators and freezers
KSFIIQuality control kits for blood banking reagents
KSGIIPotentiating media for in vitro diagnostic use
KSIIILectins and protectins
KSKIIStabilized enzyme solutions
KSLICopper sulfate for specific gravity determination
KSMIIAutomated Coombs test systems
KSNIIAutomated cell-washing centrifuges for immunohematolgy
KSOI & IIBlood bank centrifuges for in vitro diagnostic use
KSPICell-freezing apparatus and reagents (for in-vitro use)
KSQIBlood mixing and weighing devices
MYJIIBlood mixing and weighing devices, semi-automated
KSSI & IIBlood bank supplies (including temperature monitors)
KSXIIBlood grouping substances of non-human origin
KSYIBlood grouping view boxes
KSZIIAutomated blood grouping and antibody test systems
MMHTBDStand alone blood bank software
MTQIISoftware blood virus application (data management systems, not instrumentation)
MTHIITray,leukocyte typing (including qualitative HLA typing, non diagnostic)
MTIIIKit,cell screening,fetal
KSTIVacuum-assisted blood collection system
MYXIIAutomated Vacuum-assisted blood collection system
MYYISemi-automated blood component separator
KSHIIEnvironmental chambers for the storage of platelet
KSDIHeat sealing devices (crimpers)
MZIIIQualitative Test for HLA, non-diagnostic
MZHIIQuantitative Test for HLA, non-diagnostic
MYQIIAntibody Elution Kit
MYWIIIndicator, Irradiation, Blood
ZZZI & II & IIIUnclassified

Office of Blood Research and Review
Division of Hematology
Non-product-related inquires only:
Sayah Nedjar 301-827-3524

CODECLASSDEVICE
CACIIIFibrin Sealant Preparation Device
CACIIAutotransfusion Device
MZMIIFibrin Sealant Preparation Device
CAKIIBlood transfusion microfilters
GKTII & IIIAutomated blood cell separator
MYOIIFunction Test for Platelet Products
GKZIIAutomated differential cell counter (including quantitative HLA tests)
KSBIITransfer sets (including sterile docking devices)
KSRIIEmpty containers for the collection and processing
KSSI & IIBlood bank supplies
KSWIIProcessing system for frozen blood
MTMIIReagent, thrombin
MYPIIPlatelet Antibody Test
MYSIIAutomated Cryoprecipitated AHF Device
MZBIIBlood Irradiator
MZCIIBacterial Detection Systems for Platelet Transfusion Products
MZGIITest 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

CODECLASSDEVICE
KSFIIQuality control kit for blood banking reagents (including viral marker controls for donor screens
MTKIIKit, sample collection,HIV
MTLIIITest, monitor, HIV
(MTN)MYRIITest, syphilis,Treponemal (for Donor Testing)
MTOIISoftware,management microplate assay
MTPTBDAntibody to HTLV-1, ELISA
LOMIIIHepatitis, hepatitis B test, (anti-HBc IgM)
LFZIICytomegalovirus, enzyme linked immunoabsorbant assay (including donor screens)
MVZIIIHIV Testing Service
MYZIIQuality control kit for bloodborne pathogen testing of donors
MZAIIAutomated Bloodborne Pathogen Test Equipment
MYEIICMC Test for Donors
MZCIIBacterial Detection Systems for Platelet Transfusion Products
MZFIIIHIV 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

CODECLASSDEVICE
GKZIIAutomated differential cell counter
KSRIIEmpty containers for the collection and processing
LWEIIKit, bone marrow collection
MTRIIProgenitor cell enumeration
MYKIICord Blood Collection Kit
MZJIIIStem Cell Concentration System
MZKIIIStem Cell Separation System
OAOIICord Blood Processing System and Storage Container

Office of Compliance and Biologics Quality
Division of Biological Standards and Quality Control

All Pending/Cleared/Approved OCBQ Device Inquiries:
Dr. William McCormick, 301-594-6299

CODECLASSDEVICE
MTSIIChallenge Vials, Endotoxin
MZLIIQuality Control Kit for Endotoxin Test

 

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Federal Register Notices

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Contact FDA

(800) 835-4709
(240) 402-8010
Manufacturers Assistance and Technical Training Branch (CBER)

Division of Manufacturers Assistance and Training

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002