Different technological characteristics

Different technological characteristics do not rule out substantial equivalence. FDA then asks whether the differences raise different questions of safety and effectiveness and whether performance data show the device is as safe and effective as the predicate.

(B) For purposes of subparagraph (A), the term “different technological characteristics” means, with respect to a device being compared to a predicate device, that there is a significant change in the materials, design, energy source, or other features of the device from those of the predicate device.

FDA guidance: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 2014), Section IV.A, The 510(k) Review Standard (quoting section 513(i) of the FD&C Act)