A medical device data system (MDDS) is a device intended to provide one or more of the following uses:
- The electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.
- The electronic storage and retrieval of medical device data, without altering the function or parameters of connected devices.
- The electronic display of medical device data, without altering the function or parameters of connected devices.
- The electronic conversion of medical device data from one format to another, in accordance with preset specifications.
Classified as Class III systems, the FDA is now considering reclassifying these systems as Class I systems, which means many more vendors and providers will now be brought under the compliance umbrella.
