HTT and the Medical Device Development Tool Submission
We are crowdsourcing pathologists to collect data (images + pathologist annotations) that can be qualified by the FDA/CDRH medical device development tool program. If successful, the MDDT qualified data, along with a statistical software package for data the analysis, will be available to any algorithm developer to be used to validate their algorithm performance in a submission to the FDA/CDRH.
Original Proposal
Here is the original proposal submitted 15 November 2019.
- 00_MDDTproposal_TILsAnnotatedDataset_Gallas-public.pdf (324 KB, uploaded by Brandon D. Gallas 2 years 3 months ago)
We received feedback from FDA on 16 April 2020. We intend to summarize the feedback and how we have adapted our efforts.