Guidance Addresses Computational Modeling in Device Submissions

The FDA issued final guidance on standardizing the way companies report computational modeling and simulation studies, paving the way for more computer modeling in medical device trials.

Currently, the FDA handles computational modeling data on a case-by-case basis, which has led to a lack of clarity for industry. The guidance provides recommendations on formatting, organization, and content of reports of computational modeling studies used to support device submissions.

The guidance sets out uniform ways of reporting computational modeling data and includes appendices with details on formatting, organization and content of reports in five subject matter areas: fluid dynamics and mass transport; solid mechanics; electromagnetics and optics; ultrasound; and heat transfer. It does not address proper verification or validation procedures or how to design a computational modeling study. The final guidance is almost identical to draft guidance issued in January 2014.