Brandon started out with a bunch of announcements and reminders:
Update on MDDT proposal
We got a preliminary response from FDA on the MDDT proposal. I have put it on the wsi working group blog (https://nciphub.org/groups/wsi_working_group/blog/2017/05/update-on-eedap-medical-device-development-tool-proposal-can-we-get-approval-with-technical)LINK.
- The response explains the delay in the full response and it provides a limited response to our question about providing only technical performance results in the MDDT, no reader study data.
- “We are open to discussing the COU and the associated evidence as discussions about the MDDT proceed. The criteria for qualification do not necessitate clinical data, the evidence will primarily depend upon the MDDT and the context of use.“
- They say a full response will be coming within two weeks. This would be in time for us to discuss at Pathology Informatics.
Some project members have run eeDAP
- IIT was the first. Philips was the second. Have you tried? It is the first step to running an eeDAP study.