How should manufacturers document and track changes made to their 510(k) cleared devices?

Oct 1, 2024 ... ... (FDA) for its PlaqueIQ™ imaging analysis software to help physicians diagnose cardiovascular disease (CVD). PlaqueIQ is the first FDA-cleared ... Mar 21, 2022 ... Developing a new medical device? Here's how much time and cash it could take to get FDA 510(k) clearance or De Novo classification. 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, ... Apr 16, 2017 ... FDA's analysis of whether to exempt a type of device from the 510(k) requirements is specific to the devices within the generic category in ... Aug 22, 2024 ... A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a ... The US Food and Drug Administration (FDA) cleared the disc via the 510(k) pathway, which does not require clinical testing data. Instead, clearance is based on ... The FDA's 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American ... Sep 29, 2023 ... Many Software as a Medical Device and AI developers are looking to the US for a cheaper and speedier regulatory approval via an FDA 510(k) ... Aug 1, 2011 ... 1) The 510(k) clearance process generally is not intended to evaluate the safety and effectiveness of medical devices because the standard for ... The 510(k) pathway allows the clearance of a new medical device if the manufacturer shows that the device is substantially equivalent to one or more legally ...