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Purpose: Software that satisfies the definition of a “medical device” under FDA regulations is subject to the same FDA regulatory oversight as any other medical device. This guidance document provides information regarding FDA requirements when investigating medical image-based software in clinical research. In most circumstances, such deployment activities should be conducted according to the FDA Investigational Device Exemption (“IDE”) regulations set forth in 21 CFR Part 812, as administered by the Institutional Review Board (“IRB”).

Any questions, please reach out to Chris Bridge, Translational Data Science Team.

Any questions, please reach out to Chris Bridge, Translational Data Science Team.

The Defined Exam Retrieval Service enables Mass General Brigham investigators to obtain radiologic imaging studies for research purposes. Researchers may request retrieval of up to 1,000 imaging studies per request. Studies will be automatically retrieved from clinical imaging archives and stored in a temporary location that has security and access control based on IRB permissions. There is an option for images to be de-identified if required for the research protocol. The de-identification process follows the DICOM standard for de-identification and replaces/removes/modifies PHI following a standard workflow. A key to the de-identification will be provided so that the study staff can identify the studies as needed. Estimated image retrieval time is 5 days.