What are the implications for manufacturers seeking to market their devices in both the EU and the UK?

Dec 22, 2021 ... The FDA clearance is based on data from multiple studies of the ... mean tear film breakup time and meibomian gland secretion score ... Feb 14, 2025 ... The goal of the 510(k) submission is to demonstrate that the device is "substantially equivalent" to a device that has already been cleared by ... Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical! Pending 510(k) clearance, not available for sale within the United States. Check out our next-generation MRI!! Page 11. □ “FDA does not intend to object to” ... Jan 12, 2024 ... The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use ... Dec 10, 2019 ... The InSet™ Total Shoulder System is used to treat significant disability in degenerative, rheumatoid, and traumatic disease of the glenohumeral ... Deliver more personalised digital-first care and research with our enterprise platform which now has FDA 510 (K) Class II clearance for any physician-specified ... Oct 21, 2021 ... The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance. 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) ... May 21, 2017 ... Soterix Medical is the world leader in non-invasive neuromodulation and brain stimulation technology. Researchers and clinicians choose ...