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

Issue Date: September 21, 2016
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE)
Status: Final

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

For many years, computational modeling and simulation (CM&S) studies have been used by sponsors to support device design/development and have been reported in medical device submissions. These studies have traditionally been used in the areas of fluid dynamics (e.g., calculate shear stress in ventricular assist devices), solid mechanics (e.g., determine maximum stress locations in a hip implant), electromagnetics and optics (e.g., radiofrequency safety in magnetic resonance imaging, fluorescence for fiber optic spectroscopy devices), ultrasound propagation (e.g., absorbed energy distribution for therapeutic ultrasound), and thermal propagation (e.g., temperature rises with radiofrequency and laser ablation devices). The purpose of this guidance document is to provide recommendations to industry on the formatting, organization, and content of reports of CM&S studies that are used to support medical device submissions. Moreover, this guidance is also for FDA Staff, to improve the consistency and predictability of the review of CM&S studies and to better facilitate full interpretation and complete review of those studies.

Download the Guidance Document