AdvaMed® Comment Letter to FDA: Exemptions from Premarket Notification Requirements for Class II Devices

AdvaMed® Comment Letter to FDA: Exemptions from Premarket Notification Requirements for Class II Devices

In AdvaMed’s® recent comment letter to the U.S. Food and Drug Administration, AdvaMed responds to FDA’s proposed framework on exemptions from premarket notification requirements for certain Class II devices. The letter outlines key considerations to ensure that any expansion of exemption pathways maintains appropriate risk-based oversight while supporting timely patient access to safe and effective medical technologies.