USA Premarket Submission :

A premarket submission made to FDA to demonstrate your device is safe and effective for use and substantially equivalent to a legally marketed device. Your 510(k),De Novo or PMA  submission must include technical information that compares your device to one or more predicates, or similar legally marketed devices. These submissions, as well as other aspects of the submission process, must meet FDA’s necessarily thorough standards.
Navigating the premarket submission process can be very challenging, and you’ll need to partner with a firm that has broad experience and expert knowledge. SMART QARA Medical exclusively focuses on bringing medical devices to market, and we have successfully submitted dozens of 510(k), PMA and De Novo for our clients.