Medical Device Data Systems (MDDS) MDDS Definition by the FDA: According to the FDA, 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 does not include devices connected with active patient monitoring. The 4 Key elements that an MDDS shall not alter are: Electronic transfer of medical device data Electronic storage of medical device data Electronic conversion medical device data from one format to another format Electronic display of medical device data Identification of Non Device MDDS and Device MDDS as per FDA Regulations Non-Device MDDS:
Criteria Classification Regulatory Requirements Example Software functions that meet the definition of Non-Device-MDDS, medical image storage devices, or medical image communications devices Non Device MDDS Not subject to FDA's Pre-Market Review Store patient data, such as blood pressure readings, for review at a later time Software functions solely intended to transfer, store, convert formats, or display medical device data and results (including medical images, waveforms, signals, or other clinical information) Non Device MDDS Not subject to FDA's Pre-Market Review Convert digital data generated by a pulse oximeter into a format that can be printed Software functions that analyze or interpret medical device data in addition to transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results Does not fall into Non Device MDDS Subject to FDA Regulatory Oversight Display a previously stored electrocardiogram for a particular patient and it automatically detects issues.
Criteria Classification Regulatory Requirements Examples Hardware functions intended to transfer, store, convert formats, or display medical device data and results Device MDDS Not subject to FDA's Pre-Market Review A dedicated medical data storage server that archives patient data from connected medical devices like ECG machines and blood glucose monitors. The server stores the data securely without modifying it, allowing healthcare providers to retrieve and review the information as needed. Hardware functions limited to assisting the software functions: electronic transfer, storage, conversion of formats, or display of medical device data, provided they do not modify the data or control the functions or parameters of any connected medical device Device MDDS Not subject to FDA's Pre-Market Review A device that transfers patient data from various medical devices, such as glucose meters and blood pressure monitors, to a central server without altering the data. For instance, a communicator which integrates with ECG devices and helps in communicating the data from the ECG to another specific location. An in vitro device intended for assessing the risk of cardiovascular diseases or for use in diabetes management Does not fall into Device MDDS Subject to FDA Regulatory Oversight The hardware may consist of the firmware which processes and analyses the signal. In such a case it is not a Device MDDS and it needs to comply with relevant FDA's requirements.
What is Not an MDDS? General-purpose IT infrastructure in healthcare facilities that remains within its original manufactured specifications is not considered MDDS. Modifications within the predefined operational parameters are still regarded as general IT infrastructure. For instance, components performing the following functions are NOT considered MDDS if used as part of general IT infrastructure, even if they transfer, store, display, or convert medical device data along with other information:
Function Examples The electronic transfer of medical device data Network Router, Network Hub, Wireless Access Point The electronic storage of medical device data Network Attached Storage (NAS), Storage Area Network (SAN) The electronic conversion of medical device data from one format to another in accordance with a preset specification Virtualization System (e.g., VMware), PDF Software The electronic display of medical device data Computer Monitor, Big Screen Display