Federal Register Notice: FDA is making available a draft guidance document entitled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics. It is intended to provide greater clarity on the principal benefit-risk factors that FDA considers during the review process for a 510(k) submission when there are different technological characteristics between the new device and the legally marketed (predicate) device. To download this guidance, click here. To view this notice, click here.