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FDA issued a draft guidance dated 9-Feb-2016 “Display Devices for DiagnosticRadiology”.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.

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

Corporate Office

Partners located in the US (CA, FL, MA, MN, TN) and Italy.