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# Final Guide on Device Computational Modeling
- URL: https://www.fdaweb.com/final-guide-on-device-computational-modeling/
- Published: 2023-11-17T12:00:00.000Z
- Updated: 2026-09-14T14:16:32.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155818

*Federal Register* notice: FDA is making available a final guidance entitled “Assessing the Credibility of Computational Modeling and Simulation (CM&S) in Medical Device Submissions; Guidance for Industry and Food and Drug Administration Staff.” The document provides a risk-informed framework for credibility assessment of CM&S used in medical device regulatory submissions. It is intended to promote consistency and efficient reviews of medical device submissions, and increase confidence in using CM&S in regulatory submissions. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-11-17/pdf/2023-25470.pdf?ref=fdaweb.com).