FDA attempts to achive uniformity in registration dossiers for medical devices
FDA announced the availability of the final guidance entitled “Reporting of Computational Modeling Studies in Medical Device Submissions”.
The guidance represents FDA’s current position on proper formatting, organization, and content of reports of computational modeling and simulation (CM&S). Agency considers these studies a valid scientific evidence of medical device effectiveness and safety as part of the registration dossier. The guidance enlightens recommended structure of computational modeling studies of fluid dynamics and mass transport, solid mechanics, electromagnetics and optics, ultrasound and heat transfer.
Full-text guidance is available at http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm381813.pdf