30 AAOSNow October2010 Advocacy Advocacy October2010 AAOSNow 31

reviewerswrotetomembersofCongressalleginginterferenceinthereviewprocessfromFDAleadershipandfailuretoadheretointernalprocesses.CongressrespondedwithrequestsformoreinformationaboutspecificreviewsandtheAgency’sprotocols.

Muchofthiscommunicationcenteredonthereviewofonesub-mission,ReGenBiologicsInc.’sap-plicationtomarketadeviceforuseintreatinginjuriestothemeniscus.TheinternalandexternalscrutinyofthisclearanceledtotheproductbeingreviewedagainbytheFDA’sOrthopaedicandRehabilitativeDevicesPanelonMarch23,2010.Because510(k)submissionsarenotroutinelyreviewedbyAdvisoryCommitteePanels,thismoveun-derscoredtheAgency’seffortsattransparencyinthewakeofCon-gressionalscrutiny.

Additionally,areportbytheU.S.GovernmentAccountabilityOffice(GAO),releasedinJanu-ary2009,concludedthattheFDAshould“takestepstoissueregula-tionsforclassIIIdevicetypescur-rentlyallowedtoenterthemarketviathe510(k)processbyrequir-ingPMAsorreclassifyingthemtoalowerclass.”Laterthatyear,theHouseEnergyandCommerceCommitteeheldahearingonwhethercurrentregulationsweresufficienttoensurethesafetyandeffectivenessofmedicaldevices.

TheFDAconvenedaninternalworkinggroupinSeptember2009toevaluatethe510(k)programandsuggestchangestoimproveconsistency,withanemphasisonactionsthatcouldbetakenwithintheagency’sexistingstatutoryauthority.Atthesametime,theInstituteofMedicine(IOM)wascommissionedtocompleteaninde-

pendentstudyoftheprogram.TheIOMstudyisfocusedonthefol-lowingtwokeyquestions:•Doesthecurrent510(k)process

optimallyprotectpatientsandpromoteinnovationinsupportofpublichealth?

•Ifnot,whatlegislative,regula-tory,oradministrativechangesarerecommendedtooptimallyachievethegoalsofthe510(k)process?

Current statusThepreliminaryreportoftheFDA’sinternalassessmentwasreleasedonAugust6,2010,and

thepubliccommentperiodclosedonOctober4,2010.Thereportincluded70recommendations—rangingfromtheprovisionofad-ditionaltrainingandguidanceforreviewersandsubmitterstothecreationofanewsubsetofdevices.Thisnew“ClassIIb”designationwouldbe“anadministrativedes-ignationtoprovidegreaterclarityregardingwhatsubmitterswouldgenerallybeexpectedtoprovideforcertain510(k)s.”TheIOM’sre-portisdueinthesummerof2011.

AAOS involvementBoththeFDAandtheIOMhave

heldopenpublicmeetingstogatherstakeholderinput.Onmorethanoneoccasion,AAOSmembersweretheonlyphysicianassociationmembersinattendance.

Randall J. Lewis, MD,repre-sentedtheAcademyattheFDAmeetingheldFeb.18,2010,andattheIOMmeetingonMarch1.Kent Jason Lowry, MD,amemberoftheAAOSBiomedicalEngineer-ing(BME)Committee,deliveredcommentsattheIOMmeetinginJune.AschairoftheBMECom-mittee,William M. Mihalko, MD, PhD,attendedthefinalIOMpanelonJuly28.

Inallcases,theAAOSurgedbothorganizationstocarefullyas-sessthe510(k)programtoidentifyspecificareasinneedofimprove-mentandtoallowtheFDAtodeterminetheappropriateadminis-trativechangestooptimizetheef-fectivenessofitsreviewprocesses.

TheAcademy’spositionwasvalidatedbyapresentationfromRalphF.Hall,JD,representingtheUniversityofMinnesotaLawSchool.Mr.HallcomparedClassIrecallsofproductsclearedthroughthe510(k)programandthoseofproductsapprovedthroughthePMApathwaytodetermineiftherewasasignificantdifferenceintherisktopatientsfrom510(k)devices.Ofnearly20,000510(k)

510(k) frompage1

Table1:Deviceclassifications

The three device classes are based on the degree of regulatory control necessary to ensure their safety and effectiveness:

Class Description Examples

I Devices present a low risk of harm to the user and are Nonpowered breast pumps, elastic bandages, subject to general controls that are sufficient to protect tongue depressors, examination gloves, most the user. Most are exempt from the regulatory process. hearing aids, arm slings, microbial analyzers, keratoscopes

II Devices are more complicated and require special controls Powered wheelchairs, CT scanners, contact for labeling, guidance, tracking, design, lens care products, endolymphatic shunts performance standards, and postmarket monitoring. Most require Premarket Notification 510(k).

III Devices usually sustain or support life, are implanted, Pacemakers, implanted weight loss devices, or present potential unreasonable risk of illness or injury. noninvasive glucose testing devices, medical They have the toughest regulatory controls. Most of these imaging analyzers, cochlear implants, devices require Premarket Approval because general and breast implants special controls alone cannot reasonably assure their safety and effectiveness.

Source: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHTransparency/ucm203018.htm

Require Information

501(k)“SubstantialEquivalence”Decision-MakingProcess(Overview)

New Device is compared to Marketed Device

Does New Device have same intended use?

Does New Device have technological characteristics

that raise new types of safety or effectiveness questions?

Does descriptive or performance information demonstrate

equivalence?

“Substantially equivalent” determination

“Not substantially equivalent” determination

Insufficient

Information

Yes

No

No

Yes

No

Yes

See 510(k), page 31

Fig. 1Thedecision-makingprocessfor510(k)submissions,whichcomparesnewdevicestoalreadymarketeddevices.TheFDArequestsadditionalinformationiftherelationshipbetweenthenewdeviceandthe“predicate”deviceisunclear.Decisionsonintendeduseandsafetyoreffectivenessquestionsarenormallybasedondescriptiveinformationalone,butlimitedtestinginformationissometimesrequired.Descriptiveorperformanceequivalencedatamaybeinthe510(k)submission,inother510(k)submissions,classificationfiles,orliterature.

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