FDA Issues Order for Partial Exemption of Radiology Computer-Aided Detection and Diagnosis Devices from Premarket Notification

The U.S. Food and Drug Administration (FDA) has issued an order, effective September 17, 2026, granting a partial exemption from premarket notification requirements for certain radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices. This decision follows a petition and subsequent review, aiming to streamline regulatory processes for these specific medical device types.