This page provides an overview of the medical device classification and reclassification processes for the medical devices reclassified by the FDA each year. The FDA considers software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device to be software as a medical device… Medical Device Data Systems (MDDS) are hardware or software products intended to transfer, store, convert formats, and display medical device data. FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. Medical Device definition from the Medical Device Regulation MDR 2017/745 The full EU MDR Medical Device definition is: ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: