FREE ON-DEMAND WEBINAR
This webinar will focus on the key steps when preparing your 510(k) Premarket Notification and some of the common pitfalls that can occur during this process.
A 510(k) submission allows a medical device manufacturer to claim that their device is substantially equivalent to a device that is already commercially available, also known as a predicate device. It includes many components such as the device description, performance testing, and a discussion about substantial equivalence.
Choosing an appropriate predicate device, knowing how to interact with your FDA review team, and deciding what to include (and not include!) in your file are crucial components to ensure the success of your device.