On June 20, 2014, FDA issued a draft guidance entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” informing manufacturers and others “that the Agency does not intend to enforce compliance with the regulatory controls” that apply to these three types of devices.
Medical device data systems (MDDS), medical image storage devices, and medical image communications devices have been regulated as Class I, 510(k)-exempt devices. Although exempt from premarket review, they have been subject to other FDA regulatory requirements. In addition, the 510(k) exemption was subject to certain limitations (21 CFR 880.9 & 892.9), including premarket notification for MDDS intended to be used in a system assessing the risk of cardiovascular disease or in diabetes management.
FDA makes clear in the draft guidance that the regulatory controls which FDA would no longer enforce for these types of devices include registration and listing, premarket review, postmarket reporting, and the quality system regulation. In addition, the limitations on the 510(k) exemption for these devices would not be enforced.
According to the draft guidance, MDDS are “hardware or software products that transfer, store, convert formats, and display medical device data.” A MDDS does not modify the data or control the functions or parameters of any connected medical device and is not used for active patient monitoring. MDDS are classified at 21 CFR 880.6310. A medical image storage device is a device that provides electronic storage and retrieval functions for medical images (21 CFR 892.2010). Finally, a medical image communications device is a device that provides electronic transfer of medical image data between medical devices (21 CFR 892.2020).
The draft guidance proposes conforming revisions to the Mobile Medical Applications Guidance (Mobile Apps Guidance) that was issued on September 25, 2013 (see our previous blog post on the Mobile Apps Guidance here). The revisions to the Mobile Apps Guidance would shift these types of devices from the category of mobile apps that FDA intends to regulate to the category that are subject to enforcement discretion.