How to Pick a 510(k) Predicate Device — A Founder's Guide If you're a medical device founder working toward FDA 510(k) clearance, predicate device selection is one of the most consequential decisions you'll make. Get it right and your path to clearance is clear and defensible. Get it wrong and you may not discover the [...]

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 [...]