Parting ShotsParting ShotsIVD Roundtable 510(k) IVD Roundtable 510(k)

WorkshopWorkshop

Steven I. Gutman, MD, MBASteven I. Gutman, MD, MBADirectorDirector

Office of Office of In VitroIn Vitro Diagnostic Device Diagnostic Device Evaluation and SafetyEvaluation and Safety

510(k) Workshop510(k) Workshop

Product of the Industry IVD Round Product of the Industry IVD Round TableTable

Good submissions are easy to reviewGood submissions are easy to review Good submissions are fast to reviewGood submissions are fast to review Bad submissions gum up the worksBad submissions gum up the works

Clear PathwaysClear Pathways

WorkshopWorkshop GuidancesGuidances StandardsStandards ArticlesArticles Posting submissionsPosting submissions

Three Kinds of ExpertiseThree Kinds of Expertise

Regulatory acumenRegulatory acumen Scientific acumenScientific acumen Statistical acumenStatistical acumen In-houseIn-house ContractContract

FDAFDA

Sound scienceSound science Least burdensomeLeast burdensome Plain EnglishPlain English Ask for the sameAsk for the same Don’t assumeDon’t assume

Companies CanCompanies Can

Do a good jobDo a good job Quality control their workQuality control their work Use correct expertiseUse correct expertise

Common DeficienciesCommon Deficiencies

Unclear intended useUnclear intended use Failure to link data to useFailure to link data to use Poor design -- lack of correlation to Poor design -- lack of correlation to

claimclaim Failure to clarify how data generated Failure to clarify how data generated

and analyzedand analyzed Insufficient dataInsufficient data

Words of AdviceWords of Advice

Survey the fieldSurvey the field Make good choicesMake good choices Don’t assume more is moreDon’t assume more is more Utilize Pre-IDE processUtilize Pre-IDE process Bring in expertsBring in experts Don’t be afraid to question, appealDon’t be afraid to question, appeal