If all goes as planned, patients who suffer from life threatening or irreversible debilitating conditions will have faster access to new technologies.
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
A recent report describes an ambitious national medical device monitoring system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care.
The MDSAP pilot has reached a major milestone with manufacturers around the globe interested in marketing medical devices in Australia, Brazil, Canada, and the U.S. invited to participate in the program.
Popularity of smartphone applications, or apps, has increased explosively. Among the implemented functionality, more and more medical device features have started to creep in. In this article, we discuss when an app is simply fun and when it needs to be regulated as a medical device.