Issue Date: September 28, 2022
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Labeling, Radiological Health, Radiology
Status: Final
Display Devices for Diagnostic Radiology: Guidance for Industry and Food and Drug Administration 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.
Download the Guidance Document
