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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.

We received feedback from FDA on 16 April 2020. We intend to summarize the feedback and how we have adapted our efforts.

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