FDA Draft Computational Models Submission Guidance

FDA issued a new draft guidance “Reporting of Computational Modeling Studies in Medical Device Submissions”. This guidance for use of computational modeling and simulation (CM&S) studies in premarket submissions provides recommendations to industry on the formatting, organization, and content of reports of CM&S studies that are used as valid scientific evidence to support medical device submissions. Moreover, this guidance is also for FDA Staff, to help improve the consistency and predictability of the review of computational modeling and simulation studies and to better facilitate full interpretation and complete review of those studies.The full draft is at the link provided and the comment period ends April 18. 2014.