In a draft guidance released on June 20, FDA’s Center for Devices and Radiological Health (CDRH) indicated that it plans to stop regulating medical device data systems (MDDS), medical image storage devices, and medical image communications devices. As part of its rationale, CDRH cited the important foundation such health data tools provide for medical devices to be “interoperable with other types of medical devices and with various types of health information technology.”
The announcement marks a significant stage in the ongoing evolution of the agency’s approach to health data systems. Before February 15, 2011, MDDS were placed in FDA’s highest risk category for devices, Class III. On that date, the agency reclassified them as Class I, or low-risk devices. Now it proposes to exempt them from regulation altogether.
The proposal is currently in a comment period for 60 days, after which a final rule may be issued. A PDF of the proposal may be downloaded from the FDA website.