How to Build a 510(k) Without Losing Your Mind | Device & Conquer | S2:E3

Building a 510(k) isn’t just about filling in forms — it’s about telling the FDA a story they can’t say no to.In this episode of Device & Conquer , Michelle Lott and Tianna Benson unpack what really goes into preparing an FDA 510(k) submission — from substantial equivalence and predicate devices to the eSTAR template , testing requirements , and why your submission is basically a regulatory novel.…