What is the concept of "least burdensome" in the context of 510(k) submissions?

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 ... any medical devices require 510(k) clear- ance or premarket application (PMA) approval from FDA prior to commercial distribution. A firm that is purchasing ... Feb 9, 2025 ... “Prostate cancer is one of the most prevalent cancers worldwide, with an estimated one in eight men diagnosed in their lifetime. With the global ... 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 ... Nov 20, 2024 ... “THINK Surgical is excited to add the MOBIO™ Total Knee System to the TMINI System. The open platform version of TMINI is now available with ... 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, ... 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 ... 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 ... Feb 11, 2025 ... That's actually why screening is so important—it doesn't have symptoms until it's advanced. For example, bone pain would mean the cancer has ... 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 ...