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FDA Announces Release of “FDA Guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”

Computational modeling and simulation (CM&S) can sometimes be useful to demonstrate the safety and effectiveness of medical devices or incorporated into devices. On December 23, 2021, the U.S. Food and Drug Administrations (FDA) announced the release of a draft guidance, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions,” to provide clarification for medical device manufacturers seeking submission approval. FDA indicates that, while they receive regulatory submissions for computational modeling, the submissions “often lack a clear rationale for why models can be considered credible for the context of use.”

What Should Medical Device Sponsors Know?

  • The draft guidance describes a nine-step framework for evaluating the credibility of CM&S information submitted in pre-market applications.
  • The draft guidance applies to physics-based or mechanistic CM&S and not statistical or data-driven CM&S, such as those incorporating artificial intelligence or machine learning.
  • There are three types of credibility evidence (code verification, calculation verification, validation) and ten distinct categories within these three types of credibility evidence that are discussed in the draft guidance.
  • The draft guidance references ASME V&V 40 Standard and is recognized by FDA.
  • Although a pre-submission is optional, the draft guidance suggests it may be useful to receive FDA feedback on the model risk assessment and prospective adequacy assessment. A Credibility Assessment Plan is suggested for inclusion in pre-submissions, while a Credibility Assessment Report is recommended for regulatory submissions. The structure for both a Credibility Assessment Plan and Credibility Assessment Report are provided in Appendix 2 of the draft guidance.

Next Steps

FDA is extending the comment period for the guidance. Continued feedback is welcomed through public docket (FDA-2021-D-0980 @ www.regulations.gov). Submit either electronic or written comments on the draft guidance by March 24, 2022, to ensure your comments are considered before FDA begins work on the final version of the guidance.

How can NAMSA Help?

Navigating the FDA regulatory landscape can be overwhelming for any medical device manufacturer—not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving regulatory requirements, market success and accelerated timelines.

Does your software product meet FDA’s definition of a medical device? At NAMSA, our team of regulatory experts have SaMD, AI/ML and cybersecurity experience with a variety of software devices and can guide you through the challenges of this unknown regulatory environment to get your product to market in a timely manner.

NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings, to Pre-IDE preparation and FDA inspection preparation and SAMD/AI/ML reviews, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise is proven to save medical device organizations up to $17M in costs and 23 months in development timelines.

If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: https://www.namsa.com/contact-us.

Monica R. Montanez

Monica R. Montanez, MS, RAC, CQA currently serves as NAMSA's Principal Strategy Consultant. Monica has over twenty years’ experience in the medical device industry in Regulatory Affairs and Quality Assurance. Her primary focus is navigating the regulatory pathways for electro-mechanical and software driven medical devices worldwide. She has received clearance of many 510(k)s and approval of new indications for PMA device(s) of which 90% involved software. She has broad regulatory expertise in several areas of digital health, including: Software in a Medical Device (SiMD), Software as a Medical Device (SaMD), mobile medical apps, clinical decision support software, telehealth, artificial intelligence, machine learning, interoperability, cybersecurity and human factors engineering, including wireless medical devices -radio frequency (RF), electromagnetic compatibility (EMC) and electromagnetic interference (EMI). While in industry, she assisted in the development of FDA 510(k) guidance and FDA Software guidance directly with FDA. Monica holds a Masters of Science (MS) degree in Regulatory Science (RS) from the University of Southern California (USC) School of Pharmacy. Currently. she holds Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and Certified Quality Auditor (CQA) from the American Society for Quality (ASQ).