510(k) requires: Substantial equivalence to an existing device Marketing wants: "Revolutionary! Novel! Best-in-class!"  "Worlds First" These are in direct conflict. What Happens with "Best-in-Class" Novel Features If your device has several novel features that meaningfully change how it works or what it does, you're likely looking at: Option 1: Not 510(k) Eligible FDA may determine [...]

THE EVOLVE REGULATORY STRATEGIES STORY Background "I'm a former professional dancer turned medical device CEO. When we started developing an anti-fog solution for surgical endoscopes, I knew FDA clearance would be complex and expensive. I wanted to hire regulatory experts from day one. But my science team pushed back hard - they insisted consultants would [...]