Display Devices for Diagnostic Radiology

On 28 September 2022 the FDA published the final guidance on premarket notification submissions for display devices for industry and FDA staff.

This guidance document provides FDA’s recommendations regarding premarket notification (510(k)) submissions for display devices intended for use in diagnostic radiology. This guidance applies to display devices intended for diagnostic radiology as identified by their classification regulation (21 CFR 892.2050) and product codes. This includes display devices for diagnostic radiology that may be referred to as soft-copy display or medical grade monitors. The recommendations are intended to promote consistency and facilitate efficient review of display devices.