Not Sure If Software Is A Device? It's All About Intended Use,' FDA Says

摘要

FDA software compliance expert John Murray says any product can become a medical device if it meets the broad legal definition of a medical device: an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar article, .including a component part or accessory, used in the diagnosis, mitigation, treatment or cure of disease."What's important is what the intended uses are,"Murray says."If you have an intended use that meets the definition of a device,then it will be a device under the law.That would be the strictest view or interpretation of that.