How does the FDA evaluate performance data when there are differences in technological characteristics compared to the predicate?

Nov 29, 2023 ... With this unprecedented FDA clearance, Vivos redefines what it means to have a truly non-invasive treatment for all levels of OSA severity. The goal of a FDA 510k submission is to demonstrate that the device being brought to market is at least as safe and effective to another legally marketed ... Aug 12, 2021 ... When a medical device is cleared, this means it has undergone a 510(k) submission, which the FDA has reviewed and provided clearance. For Class ... Aug 4, 2022 ... “When Xoran states that TRON is the 'One RING to rule them all,' we truly mean that this compact, mobile, open-bore device is poised to ... Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical! Sep 19, 2022 ... The 510(k) approval process is an FDA requirement for medium-risk medical devices such as self-fitting hearing aids. Jan 24, 2023 ... What does this all mean for you? It means we did the work to ... What that means: A 510(k) filing contains detailed technical, safety ... Mar 18, 2024 ... What do the different FDA terms mean? Regulatory professionals ... All other Class II devices require 510(K) clearance as a premarket ... Jan 3, 2024 ... May is an incredibly variable month for FDA decision-making and I don't honestly know why. Variability means that there's a lack of consistency, ... Jan 7, 2025 ... This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve and is specifically designed so that it can ...