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Parting Shots IVD Roundtable 510(k) Workshop

Parting Shots IVD Roundtable 510(k) Workshop. Steven I. Gutman, MD, MBA Director Office of In Vitro Diagnostic Device Evaluation and Safety. 510(k) Workshop. Product of the Industry IVD Round Table Good submissions are easy to review Good submissions are fast to review

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Parting Shots IVD Roundtable 510(k) Workshop

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  1. Parting ShotsIVD Roundtable 510(k) Workshop Steven I. Gutman, MD, MBA Director Office of In Vitro Diagnostic Device Evaluation and Safety

  2. 510(k) Workshop • Product of the Industry IVD Round Table • Good submissions are easy to review • Good submissions are fast to review • Bad submissions gum up the works

  3. Clear Pathways • Workshop • Guidances • Standards • Articles • Posting submissions

  4. Three Kinds of Expertise • Regulatory acumen • Scientific acumen • Statistical acumen • In-house • Contract

  5. FDA • Sound science • Least burdensome • Plain English • Ask for the same • Don’t assume

  6. Companies Can • Do a good job • Quality control their work • Use correct expertise

  7. Common Deficiencies • Unclear intended use • Failure to link data to use • Poor design -- lack of correlation to claim • Failure to clarify how data generated and analyzed • Insufficient data

  8. Words of Advice • Survey the field • Make good choices • Don’t assume more is more • Utilize Pre-IDE process • Bring in experts • Don’t be afraid to question, appeal

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