The Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices final guidance has been released. The FDA posted a regulation down-classifying Medical Device Data Systems (MDDS) from Class III to Class I on February 15, 2011. Class I devices are subject to general controls under the FD&C Act. A draft guidance regarding MDDS was issued on June 20, 2014. On February 9, 2015 the FDA released the final guidance on Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. This guidance explains the FDA’s position on the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices.

An MDDS is a hardware or software product that transfers, stores, converts formats, and displays medical device data. An MDDS does not change the data, does not control a connected medical device, and does not include devices used for active patient monitoring. A medical image storage device provides electronic storage and retrieval for medical images. A medical image communications device provides electronic transfer of medical image data between medical devices. Read more here on how the FDA classifies a medical device.

Devices that meet these definitions are a low risk to patients and they can greatly advance digital health. Therefore, the “FDA will not enforce compliance with regulatory controls, registration and listing, premarket review, postmarket reporting, and quality system regulation to MDDS devices, medical image storage devices, and medical image communications devices.”