Beck 2024 510 K. Redirecting the regulatory strategy from the special 510 (k) to the traditional 510 (k). However, there is no user fee for 510 (k)s submitted to the.

510 (k) premarket notification 510 (k) premarket notification fda home medical devices databases Fda 510 (k) submission (premarket notification) the purpose of a 510 (k) submission is to demonstrate that a medical device is similar enough to an fda.