Premarket Notification 510(k) submissions to the FDA

Three types of Premarket Notification 510(k) submissions to the FDA are

• Abbreviated
• Special
• Traditional

The FDA introduced the Special and Abbreviated 510(k) programs in 1998 to make the review process more accessible for specific submissions. Initially, these programs were explained in a guidance called "The New 510(k) Paradigm." In 2019, the FDA updated this into two separate guidance documents: one for the Special 510(k) Program and one for the Abbreviated 510(k) Program. If your submission meets specific criteria, you can use the Special and Abbreviated 510(k) types.

The Traditional 510(k) Program can be used for any device to get FDA approval for marketing. Instead of a specific form, a 510(k) submission includes all necessary information according to FDA regulations (21 CFR 807.87). Every 510(k) shows that the new device is substantially equivalent to an already approved device, called a predicate. This involves comparing the new device to the predicate device to prove they are similar (https://www.fda.gov/medical-devices/premarket-notification-510k/how-prepare-traditional-510k)