What are the requirements for reporting device malfunctions under the Medical Device Reporting (MDR) regulation?

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 ... Sep 19, 2022 ... The 510(k) approval process is an FDA requirement for medium-risk medical devices such as self-fitting hearing aids. 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 ... 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 ... 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 ... Many of the products submitted to the FDA for clearance use the 510(k) regulatory approval process. ... The phrase “substantially equivalent” means your ... Mar 17, 2025 ... What does the FDA 510(k) clearance mean for Monogram's mBôs TKA System (MGRM)?. The clearance allows Monogram to legally market and sell ... any medical devices require 510(k) clear- ance or premarket application (PMA) approval from FDA prior to commercial distribution. A firm that is purchasing ... 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. Aug 12, 2021 ... When a medical device is cleared, this means it has undergone a 510(k) submission, which the FDA has reviewed and provided clearance. For Class ...