Reporting of Computational Modeling Studies in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Investigational Device Exemption (IDE), Premarket
Published
September 21, 2016
Last updated
March 17, 2019
Description
This document provides guidance on reporting computational modeling studies in medical device submissions for FDA staff and industry.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)