What types of questions can be addressed during a pre-submission meeting with the FDA?

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 ... May 29, 2024 ... This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a ... Jan 10, 2013 ... Because many predicates have never been assessed for safety and effectiveness, an FDA finding of substantial equivalence does not mean that a ... Jan 27, 2025 ... LYNX is battery-powered and provides surgeons an untethered laser ... Faster LIO treatments means less ergonomic stress, more quality ... Apr 11, 2023 ... A 510(k) clearance means that FDA has completed its review of the 510(k) review and determined that the device is substantially equivalent to an ... Jul 21, 2016 ... The INTRACEPT System is the first specific therapy to relieve chronic low back pain (CLBP) of at least six months duration that has not responded to at least ... Premarket Notification vs Premarket Approval. Phillips stressed that the premarket notification, or 510(k), process is a classification process, whereas PMA is ... Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. ... The phrase “substantially equivalent” means your ... Jun 5, 2024 ... A legally marketed predicate means the device has previously gone through a 510(k) clearance process and obtained FDA clearance or was on the ... 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 ...