Monday
Jul252011
FDA Releases Draft Guidance on Mobile Apps
Monday, July 25, 2011 at 11:56AM US FDA announces publication of draft guidance on Mobile Medical Applications. FDA signals a “narrowly-tailored approach” focussing on a subset of apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device but the scope is still broad and includes anything that meets the definition of a device under the FD&C Act.
tagged FDA, FDA guidance, Mobile apps, software validation IEC 62304, ssoftware | Tweet
FDA, FDA guidance, Mobile apps, software validation IEC 62304, ssoftware | Tweet 