What are the reporting requirements for serious adverse events that occur during a clinical investigation?

... 510(k) process; the agency gives the nod for them to be marketed in the U.S. Please note that FDA approval and FDA clearance mean the same. Premarket ... 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) ... Jan 12, 2024 ... The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use ... Premarket Notification vs Premarket Approval. Phillips stressed that the premarket notification, or 510(k), process is a classification process, whereas PMA is ... Mar 22, 2025 ... This determination means ... Ben Sexson, Monogram Chief Executive Officer, commented, “This FDA 510(k) clearance is a defining moment for Monogram ... 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 ... Jan 10, 2023 ... Main Outcomes and Measures Class I or class II recall of a 510(k) medical device between its FDA regulatory clearance date and December 31, 2020 ... Oct 21, 2021 ... The Premarket Notification, or 510(k) submission, is the mechanism through which the majority of medical devices obtain US marketing clearance. Nov 30, 2020 ... The 510(k) regulatory clearance pathway is used to demonstrate to the FDA ... Notably, “substantially equivalent” does not mean identical! Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, and the ...