Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

FDA issued a final guidance on Medical Device Data Systems for industry and FDA staff on September 27, 2019. The policy described in this guidance document is also consistent with the Agency’s updated guidance entitled “Policy for Device Software Functions and Mobile Medical Applications,” originally issued on February 9, 2015, with the title “Mobile Medical Applications.”

The FDA recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software, typically referred to as medical device data systems (MDDS) that transfer, store, convert formats, and display medical device data or medical imaging data.