Devices

Computational Modeling Studies Reporting Guidance

FDA has issued a guidance, Reporting of Computational Modeling Studies in a Medical Device Submission, with recommendations for industry on the formatting, organization, and content of reports of computational modeling and simulation (CM&S) studies used to support medical device submissions. The document says its recommended format aims to establish uniformity in reporting CM&S studies.

“FDA recognizes that the level of detail to be reported will vary and will depend on the context of use for the CM&S studies,” the guidance says. “Moreover, there are a variety of CM&S modalities and thus the specific details will vary across disciplines…. The main body is written in general terms to capture reporting for any modality. Five appendices provide more background, structure, and specific terminology for the following subject areas: fluid dynamics and mass transport, solid mechanics, electromagnetic and optics, ultrasound, and heat transfer.”

The guidance’s scope is limited to how CM&S studies and their outcomes can be used to support a regulatory submission when medical devices use such studies to determine safety and effectiveness. It does not address or make a determination of whether CM&S tools may be considered medical devices.

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