FDA 510(k) Clearance and Premarket Approval for USA
What is FDA 510(k)? The FDA 510(k) is a required submission for most medical devices in the U.S., demonstrating that a new device is substantially equivalent to an existing approved device. This process ensures safety and effectiveness before market clearance. Operon Strategist assists manufacturers by providing expert guidance through the 510(k) submission process, including initial assessments, information gathering, and compliance with FDA regulations, ensuring a seamless path to certification.