Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff

Issue Date: September 28, 2022
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Digital Health, Radiology, Labeling
Status: Final

Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions: Guidance for Industry and FDA Staff

This guidance document provides FDA’s recommendations on clinical performance assessments to support premarket notification (510(k)) submissions for computer-assisted detection (CADe) devices applied to radiology images and radiology device data. This guidance applies to CADe devices, including when a CADe device is part of a combined system, such as the detection portion of combined computer-aided detection and diagnostic devices. The recommendations are intended to promote consistency and facilitate efficient review of clinical performance assessments in CADe 510(k) submissions.

Download the Guidance Document