Me al De e and Medic edica evice d cal De evice Cla catio assific on

By Chris y stian S Yorgu ure Lig Fab ght bricati ions, In nc.

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Introduction Workingwithmanystartupsandbusinessesventuringintothemedicaldevicemarket,ithas becomecommonknowledgethatthetermmedicaldeviceisconfused.Themajoritybelieves thatamedicaldevicemustpossesssomemechanicalcomponents,andothersquicklydismiss thefacttheirdeviceisclassedandregulated.Thispaperisintendedtoclearthemurkinessthat thesemisconceptionsintroduce.Thegoalbeingtoreducethetimetakenbycontract manufacturingorganizationssuchasLightFabrications,Inc.inconvincingstartupbusinesses andindividualinventorsonwhatisamedicaldeviceanditsclassasmaybeapplicable accordingtotheprovisionsoftheUnitedStatesFoodandDrugAdministration(FDA). TheFoodandDrugAdministration(FDA)regulatemedicaldevice.Title21oftheCodeof FederalRegulations(CFR)containsarticlesarticulatingtheproceduresandstandardsgoverning CurrentGoodManufacturingPractices(cGMP)ofmedicaldevices. About1,700devices,groupedinto16medicalspecialtiesorpanelsareclassifiedintothree broadcategories.ThedescriptionofeachpaneliscontainedinTitle21CFR,Parts862892,and eachclassisdefinedbyregulatorycontrolsimposedbytheFDAtoensurethesafetyand effectivenessofthedevice.Letusunderstandwhatisamedicaldeviceisbeforedelvingintoits classification. Whatisamedicaldevice? TheFoodandDrugAdministration(FDA),definesmedicaldeviceas: "Aninstrument,apparatus,implement,machine,contrivance,implant,invitroreagent,or othersimilarorrelatedarticle,includingacomponentpart,oraccessorywhichis:

recognizedintheofficialNationalFormulary,ortheUnitedStatesPharmacopoeia, oranysupplementtothem, intendedforuseinthediagnosisofdiseaseorotherconditions,orinthecure, mitigation,treatment,orpreventionofdisease,inmanorotheranimals,or intendedtoaffectthestructureoranyfunctionofthebodyofmanorotheranimals, andwhichdoesnotachieveanyofitsprimaryintendedpurposesthroughchemical actionwithinoronthebodyofmanorotheranimalsandwhichisnotdependent uponbeingmetabolizedfortheachievementofanyofitsprimaryintended purposes."(FDA,2011) Medicaldevicecontrolsandclassification Allthreeclassesaresubjecttogeneralcontrolsandsomespecialcontrols.Controlsare procedures,andorprocessesthatmanufacturersanddistributorsofmedicaldeviceMUST implement,unlessincaseswhereexemptionstatusprevail.FDAspecifiedGeneralControlsand SpecialControlsare:
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GeneralControls

Adulteration/Misbranding ElectronicEstablishmentRegistration ElectronicDeviceListing PremarketNotification[510(k)] QualitySystems Labeling MedicalDeviceReporting(MDR)

SpecialControls

Guidelines MandatoryPerformanceStandard RecommendationsorOtherActions SpecialLabeling

Thethreeclassesare: 1. ClassI SubjecttoGeneralControlswithandwithoutexemptions Thisistheclasswiththelowestriskdevices;containingmostlynoninvasivedevices.. Examplesincludemosttypesofbandageelastic,liquid,cast,absorbentetc.,hydrogel wounddressing,stethoscopes,hospitalbeds,wheelchairs. 2. ClassII SubjecttoGeneralControlsandSpecialControlswithandwithoutexemptions Thisclasshaslowtomediumtohighriskdevices;examplesofthelowtomediumrisk devicesincludehearingaids,electrocardiographs,ultrasonicdiagnosticequipment, drapessurgical,urological,etc. ExamplesofmediumtohighriskdevicesinClassIIaresurgicallasersinfusionpumps (nonimplantable),ventilators,intensivecaremonitoringequipment. 3. ClassIII SubjecttoGeneralControlsandPremarketApproval ClassIIIdevicesarehighriskdevices;failurewouldresultinadversehealthconsequence orfatality.Theseareusuallylifesustaining,andorlifesupportdevices.Examplesinclude ballooncatheters,prostheticheartvalves,Implantablepacemakerpulsegenerator, implanteddiaphragmatic/phrenicnervestimulator,pacemakerbattery,etc. Classificationofamedicaldevicedependsontwofactors,itsuseanditsrisktopatientoruser. Thedegreeofcontrolisafunctionoftherisklevel;orputdifferently,itisafunctionofthe
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propensityforadverselossduetomalfunctioningofthedevice.Apparently,ClassIdevices poselesserrisktothepatientoruser,whileClassIIIdevicesposegreaterrisk.Noticethat ClassesI&IImayenjoysomeexemptions,whileClassIIIdoesnot.Thelevelofriskassociated withadevicemaybededucedfromitsuse,hencetheimportanceofusetotheclassification process. Theindicatedandintendedusegreatlyimpactmedicaldeviceclassification.Theintendeduse ofadeviceisfundamentallythepurposeofthedevice;itpredictstherisklevelanddrivesits classification.Medicalproductlabelingisalsobigonintendeduseasstipulatedintitle21CFR Part809. DetermineClassification TheFDAmaintainaclassificationdatabaseofmedicaldevicesat http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm Onceatthesite,simplytypeinthenameofthedeviceandchoosetheitemorthatwhichbest resemblesyourdevicefromthelistofresults.Doubleclickonyourchoiceofdevicetoseethe classandotherdetailsincludingcontrolsandexemptions,etc. References FDA(2011).ProductClassification.Retrievedfrom http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm FDA(2011).Presentation:OverviewofRegulatoryRequirementsMedicalDevices.Retrieved fromhttp://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm126245.htm FDA(2010).Whatisamedicaldevice?Retrievedfrom
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm211822.htm

FDA(2010).WhatdoesitmeanforFDAto"classify"amedicaldevice?Retrievedfrom
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm

FDA(2009).DeviceClassification.Retrievedfrom http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyY ourDevice/default.htm.

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