In general, the 510 k premarket notification for devices in the U.S. marketplace are clearances by FDA as findings of substantial equivalence (SE). These devices usually follow simpler regulatory processes than the PMA device route.
The FDA 510(k) clearance timeline is variable based on the complexity of the device and ability of the Center for Devices and Radiological Health (CDRH) to review submissions in a timely manner.
A device manufacturer must notify FDA that they intend to market a medical device at least 90 days ahead of launch. This Premarket Notification, better known as the 510(k). is the source of information for FDA determination of SE. SE depends on selection of one or more predicate devices, usually also 510(k) devices.
Since September 2019, FDA has finalized a guidance for abbreviated 510(k)s. This ‘voluntary’ program uses special controls and voluntary consensus standards to facilitate review. This program is designed to conserve sponsor and FDA resources and is not to alter decisions of SE. There are FDA-recognized standards and methods for submission.
Sponsors should know that there are also devices that require De Novo requests to FDA. These are to avoid 510(k) submissions that do not have proper predicate devices and would be found not SE. FDA notes in 2019 that proper De Novo submissions can “save medical device manufacturers unnecessary costs and reduce our review times.” De Novo requests should allow device sponsors to more quickly introduce their novel medical products to the market.
A medical device expert can help guide the assembly of information, proper device submissions and optimized interactions with FDA.