510(k) Submission: Ensuring FDA Clearance for Medical Devices

Tue, 06 May 2025 05:32:29 +0000

A 510(k) submission is a premarket notification filed with the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is safe, effective, and substantially equivalent to a legally marketed predicate device. This process is essential for most Class II and select Class I devices before entering the U.S. market.