> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guidance on Reporting Device Studies on Computational Modeling
- URL: https://www.fdaweb.com/guidance-on-reporting-device-studies-on-computational-modeling/
- Published: 2016-09-21T12:00:00.000Z
- Updated: 2026-09-14T21:33:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136877

*Federal Register* Notice: FDA has released a guidance entitled “Reporting of Computational Modeling Studies in Medical Device Submissions.” The document provides recommendations to industry on the formatting, organization, and content of reports of computational modeling and simulation studies that are used as valid scientific evidence to support medical device submissions, and to assist FDA staff in the review of such submissions. To view the guidance, click [here](http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM381813.pdf?ref=fdaweb.com). To view this notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2016-09-21/pdf/2016-22708.pdf?ref=fdaweb.com).