Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Medical Devices
Topics
Digital Health, Premarket
Published
November 17, 2023
Last updated
November 16, 2023
Description
This document is a guidance for industry and FDA staff on assessing the credibility of computational modeling and simulation in medical device submissions.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)