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 Bad submissions gum up the works

Clear Pathways Workshop Guidances Standards Articles Posting submissions

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

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

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

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

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