US FDA announces publication of draft guidance on Mobile Medical Applications.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.
Archives for July 2011
The European Restriction of Hazardous Substances (RoHS) directive has been updated by release of Directive 2011/65/EU. The Directive now includes medical devices and IVDs (except for active implants) within its scope. The Directive mandates Technical Files, records retention and traceability information.