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# Comments on Computational Modeling Guidance
- URL: https://www.fdaweb.com/comments-on-computational-modeling-guidance/
- Published: 2022-03-29T12:00:00.000Z
- Updated: 2026-09-14T17:38:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151473

AdvaMed says an FDA draft guidance on assessing the credibility of computational modeling and simulation in medical device submission “is an important step toward highlighting the importance of rules and physics-based modeling and simulation in the form of evidence in a regulatory submission.” The association’s comment [letter](https://www.regulations.gov/comment/FDA-2021-D-0980-0015?ref=fdaweb.com) says it is important that computer modeling and simulation is viewed in combination with other types of evidence that are part of a regulatory submission. “We encourage FDA in the future to issue a guidance that focuses on evidence credibility holistically based on context of use and not type of model (e.g., animal, bench, computer, human),” the letter says.

AdvaMed also submitted line-by-line specific comments, as did [Stryker Orthopedics](https://www.regulations.gov/comment/FDA-2021-D-0980-0014?ref=fdaweb.com) and [Johnson & Johnson](https://www.regulations.gov/comment/FDA-2021-D-0980-0012?ref=fdaweb.com).