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HTT and the Medical Device Development Tool Program Description

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.

Our pilot study has provided valuable feedback about issues needed to create a generalizable dataset fit for a regulatory purpose: study size, stratified sampling of the patient population, and required pathologist training and qualifications.

We will next solicit feedback from the FDA via the MDDT program and from the broader digital pathology and AI community. Ultimately, we intend to share the dataset, statistical methods, and lessons learned.

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