FDA Issues Draft Guidance on Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

Today, the U.S. Food and Drug Administration (FDA) issued the draft guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The FDA is seeking input from industry, researchers, and other interested stakeholders on the draft guidance.

The FDA developed this draft guidance document to assist industry and FDA staff in assessing the credibility of Computational Modeling and Simulation (CM&S) used to support medical device regulatory submissions. This draft guidance is only applicable to certain computational models (for example, physics-based or mechanistic) and not others (for example, machine learning or artificial intelligence) models.

Read the Draft Guidance

Facts about the draft guidance

This draft guidance, when finalized, is intended to:

• Help improve the consistency and transparency of the review of CM&S evidence
• Increase confidence in the use of this evidence in regulatory submissions
• Facilitate improved interpretation of this evidence submitted in regulatory submissions reviewed by FDA staff

Note: This draft guidance is not for implementation.

Submit comments on this draft guidance

This draft guidance will be open for public comments for 60 days at www.Regulations.gov under docket number FDA-2021-D-0980.

Questions?

If you have questions about this draft guidance, email OSEL_credibilityofmodels@fda.hhs.gov.