The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices draft guidance has been released to communicate the FDA’s standpoint on enforcing regulatory controls in regards to digital health efforts. The FDA understands that medical device access to digital technology has the opportunity to create more efficient and improved patient care. This draft guidance discusses how medical devices and this digital technology will work together.
Medical devices and Medical Device Data Systems (MDDS) are “hardware or software products that transfer, store, convert formats, and display medical device data.” (FDA) A MDDS does not change data, control any part of the connected medical device, and cannot be used with active patient monitoring. Mobile apps within the proper parameters will be categorized as MDDS. Medical Device Data Systems, Medical Image Storage Device, and Medical Image Communications Devices draft guidance also states that the FDA does not anticipate enforcing “compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices.” (FDA)