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Enhancing IVD Submissions: Insights from the FDA 510(k) Workshop

Join Dr. Steven I. Gutman for a comprehensive discussion on the importance of quality submissions in the in vitro diagnostics (IVD) field during the 510(k) workshop. Learn about effective pathways for submission, the significance of clear communication, and the need for scientific, regulatory, and statistical expertise. Understand common deficiencies in submissions and gain valuable advice on utilizing the Pre-IDE process, engaging experts, and ensuring well-structured data presentation. Elevate your submission strategy for clearer, faster FDA reviews.

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Enhancing IVD Submissions: Insights from the FDA 510(k) Workshop

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Presentation Transcript

  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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