1. Parting Shots IVD 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