The 510 (k) process is intended for devices that are equivalent to existing devices that are already on the market and have known risks. A PMA process is intended for novel devices that have no similar devices on the market. The cost difference between the two pathways is about 100x.What is a 510 (k) Premarket Submission?
A 510 (k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent) to a legally marketed device that is not subject to PMA.What are some examples of 510 (k) devices?
All three examples you provided (i.e. – insulin pump, AED, and glucose monitoring device) are all 510 (k) devices.When is a special 510k required for device modification?
Also, a Special 510k is only possible if the device modification requires a single technical discipline to review the change. For example, changes to software and materials require a review of software validation and biocompatibility. Therefore, two reviewer specialists must coordinate their efforts, and the review cannot be completed in 30 days.