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# Computational Modeling Credibility Guidance
- URL: https://www.fdaweb.com/computational-modeling-credibility-guidance/
- Published: 2022-01-03T12:00:00.000Z
- Updated: 2026-09-14T17:26:55.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150826

FDA has published a draft guidance, *Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions*, to provide a risk-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-medical-devices-physiologic-closed-loop-control-technology?ref=fdaweb.com) defines credibility as trust in the predictive capability of a computational model used to support medical device submissions.

For this guidance, CM&S refers to first principles-based computational models and not statistical or data-driven models. The document is intended to help improve the consistency and transparency of CM&S evidence, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S evidence submitted in regulatory submissions reviewed by FDA staff.

In the guidance are Introduction, Background, Scope, Definitions, Generalized Framework for Assessing Credibility of Computational Modeling in a Regulatory Submission, Key Concepts for Assessing Credibility of Computational Modeling in a Regulatory Submission, and two appendices.