U.S. Food and Drug Administration (FDA): Medical Device Data Systems

Medical Device Data Systems or MDDS is a collection of hardware or software products used for storing, transferring, converting formats, and displaying data from the medical device. This system (MDDS medical device) does not have the control to modify the data or the display of the data. Software functions that perform data storage, data transfer, format conversion, and data display are not subject to FDA regulatory requirements otherwise needed for devices.