Zdrowie i gospodarka · 21.09.2016

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

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Reporting of Computational Modeling Studies in Medical Device Submissions." The purpose of this guidance document is to provide recommendations to industry on the formatting, organization, and content of reports of computational modeling and simulation (CM&S) studies that are used as valid scientific evidence to support medical device submissions, and to assist FDA staff in the review of computational modeling and simulation studies by improving the consistency and predictability of the review of CM&S and facilitating full interpretation and complete review of those studies.