FDA Draft Display Devices for Diagnostic Radiology

FDA issued a draft guidance dated 9-Feb-2016 “Display Devices for DiagnosticRadiology”. The guidance is at the link provided. This guidance may cause some confusion since software for medical imaging is outside its scope and described in a much earlier separate guidance. The new guidance focuses on physical display devices but includes the software/firmware embedded in these devices. The guidance indicates these devices are Class II requiring a 510(k) although most simple Medical Image Management software devices do not require 510(k)s based on the other guidance. Appendix B of the new guidance discusses Device modifications and states changes in graphics drivers and calibration software most likely would not require a new 510(k). The guidance also discusses Device Bundling in 510(k) submissions in Appendix C. Section 7 defines specific physical laboratory testing to perform and Section VIII provides extensive specifics and labeling requirements.

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