Medical Device Data Systems (MDDS) are hardware or software products intended to transfer, store, convert formats, and display medical device data. A MDDS does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS may or may not be intended for active patient monitoring.
Per section 520(o)(1)(D) of the Federal Food, Drug, and Cosmetic Act:
- Software functions that are solely intended to transfer, store, convert formats, and display medical device data or medical imaging data, are not devices and are not subject to FDA regulatory requirements applicable to devices. The FDA describes these software functions as "Non-Device-MDDS."
- Hardware functions that are solely intended to transfer, store, convert formats, and display medical device data or results are "Device-MDDS."
Examples of Non-Device-MDDS include software functions that:
- Store patient data, such as blood pressure readings, for review at a later time;
- Convert digital data generated by a pulse oximeter into a format that can be printed; and
- Display a previously stored electrocardiogram for a particular patient.
For additional information, see the "Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices" Guidance.