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FDA issued a draft guidance dated 9-Feb-2016 “Display Devices for DiagnosticRadiology”.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

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.