Articles tagged with “substantial-equivalence”

FDA 510(k) Explained: Medical Device Premarket Notification

Understand the FDA 510(k) premarket notification process for Class II medical devices. This guide covers substantial equivalence, predicate devices, and key ste

45 min read

11/14/2025

fda 510k premarket notification medical device regulation substantial equivalence predicate device class ii medical device regulatory affairs fda clearance