Zdrowie i gospodarka · 17/01/2014

Reporting of Computational Modeling Studies in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Reporting of Computational Modeling Studies in Medical Device Submissions." Computational modeling and simulation (CM&S) studies are often used by sponsors as a tool to support medical device applications. The purpose of this draft guidance document is to provide recommendations to industry on the formatting, organization, and content of reports of CM&S studies that are used as valid scientific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, and to assist FDA staff in the review of computational modeling and simulation studies by improving the consistency and predictability of the review and facilitating full interpretation and complete review of those studies. This draft guidance is not final nor is it in effect at this time.