![FDA to Overhaul 510(k) Device Approval Process](https://www.regdesk.co/wp-content/uploads/2018/11/Medical-device-industry-trends-are-driven-by-different-factors.jpg)
FDA to Overhaul 510(k) Device Approval Process
Established in 1976, a 510(k) is a “premarket submission made to FDA [by medical device manufacturers] to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not...