# Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/assessing-the-credibility-of-computational-modeling-and-simulation-in-medical-device-submissions-guidance-for-industry-and-food-and-drug-administration-staff/deda9f0c-89aa-46ae-8793-ff31b91a4909

> FDA guidance document: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: November 17, 2023. Get complete insights and analysis.

---

## Details

- Title: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2023-11-17
- Comment Close Date: 2022-03-24
- Last Changed: 2023-11-16
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-0980">FDA-2021-D-0980</a>

## Related Documents

- [Reporting of Computational Modeling Studies in Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/reporting-of-computational-modeling-studies-in-medical-device-submissions-guidance-for-industry-and-food-and-drug-administration-staff/422a1a1e-f32d-4df7-a042-f1af0d663768)
- [Qualification of Medical Device Development Tools:  Guidance for Industry, Tool Developers, and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/qualification-of-medical-device-development-tools-guidance-for-industry-tool-developers-and-food-and-drug-administration-staff/392746b7-77c7-453d-abc3-dea7880c9864)
- [Pediatric Information for X-ray Imaging Device Premarket Notifications:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/pediatric-information-for-x-ray-imaging-device-premarket-notifications-guidance-for-industry-and-food-and-drug-administration-staff/7a347f68-87ec-48b0-b385-4a82d1ebd6a3)