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The recommended format provided in this document 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. Moreover, there are a variety of CM&S modalities and thus the specific details will vary across disciplines. Therefore, we have provided a general outline in the main body of this document and five subject matter appendices for CM&S modalities that are widely used in regulatory submissions. The main body is written in general terms to capture reporting for any modality. The five appendices provide more background, structure, and specific terminology for the following subject areas:
I. Fluid Dynamics and Mass Transport
II. Solid Mechanics
III. Electromagnetics and Optics
IV. Ultrasound
V. Heat Transfer

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