News & Insights

Why should you care about Essential Performance? Essential performance are equipment specifications that, if one or more fail to be achieved during intended use, the result is the risk of patient harm. If you do not define the essential performance of your product you will not be able to fully claim…

Introduction The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees are intended to be used by FDA on the resources needed to support the review of marking…