On November 17, 2023, FDA published a new guidance document titled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”. Within this context, credibility is defined as “the trust in the predictive capability of a computational model.” Computational Modeling and Simulation (CM&S) is becoming more and more prevalent within various submission types including 510(k)s, Premarket Approval (PMA) Applications, Humanitarian Device Exemption (HDE) Applications, Investigational Device Exemption (IDE) Applications, and De Novo classification requests, as well as Medical Device Development Tools (MDDTs). Consequently, consistency and transparency in the ways CM&S is performed, utilized, and documented is essential to increase the likelihood of a seamless and efficient FDA review process.
FDA recognizes that computational models can be used in a variety of ways in medical device regulatory submissions, including but not limited to: (i) In silico device testing, (ii) CM&S used within medical device software, (iii) In silico clinical trials, and (iv) CM&S-based qualified tools. Documentation must clearly address model credibility. Demonstrating credibility involves various activities that include verification, validation, uncertainty quantification, applicability analysis, as well as adequacy assessment, all of which are explained within the guidance document. FDA further stipulates that “for in silico device testing and in silico clinical trials, final simulation results should be submitted to FDA with supporting credibility evidence so that FDA can assess the credibility of those simulation results. For CM&S in medical device software and MDDTs, example simulation results should be submitted to FDA with supporting credibility evidence so that FDA can assess if future simulations (to be performed post-market or post-tool qualification) are expected to be credible.”
To clearly demonstrate the credibility of a computational model, FDA recommends the following:
The 42-page guidance document provides very detailed information, illustrations/flow-charts, and examples relating to each of these steps, as well as definitions of all applicable terms. Medical device manufacturers should be sure to carefully review the guidance document and ensure not only a thorough and complete understanding of all recommendations but also a clear and effective approach for implementation.
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