# Reporting of Computational Modeling Studies in Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: 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

> FDA guidance document: Reporting of Computational Modeling Studies in Medical Device Submissions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: September 21, 2016. Get complete insights and analysis.

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## Details

- Title: Reporting of Computational Modeling Studies 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: 2016-09-21
- Last Changed: 2019-03-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2013-D-1530">FDA-2013-D-1530</a>

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