> This is the "efficacy" part of "safety and efficacy".
Yes. FDA 100% cares if your device works as well. "Works as well as the predicate" is the foundation of the substantial equivalence paradigm that underlies the 510(k) process.
Better is a different story. Legally, they _can't_ care (in a 510(k) anyway), if it works better or not.
Yes. FDA 100% cares if your device works as well. "Works as well as the predicate" is the foundation of the substantial equivalence paradigm that underlies the 510(k) process.
Better is a different story. Legally, they _can't_ care (in a 510(k) anyway), if it works better or not.