What is the Medical Device User Fee Amendments (MDUFA) program and its impact on 510(k) submissions?

Jan 30, 2025 ... In addition to the clearance, AI Optics is ... A total of 196 patients (48.5% women; mean age, 61 years) were identified who had been referred for ... Aug 22, 2022 ... The step means that Nerve Tape's development partner, Atlanta ... Nerve Tape is the company's first FDA-cleared medical device and ... Apr 19, 2023 ... At this time, the FDA does NOT approve hearing aids, and no one can claim that a hearing aid is FDA-approved. What is 510(k) FDA approval? Oct 6, 2020 ... Although FDA's 510(k) program is the most ... clearance, meaning that manufacturers can market their device without clearance from the FDA. FDA clearance through the 510(k) process means the agency is in agreement with the manufacturer that a medical device is similar to a previously approved ... Jun 14, 2021 ... ... 510(k) process is focused on equivalence, not safety.'"10. The Court was critical of the amount of time and resources the FDA spends on 510(k) ... FDA 510(k) Medical Device Clearance. The 510(k) pathway is based on ... A claim of substantial equivalence does not mean the device(s) must be identical. Oct 21, 2021 ... The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance. Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of ...