Touting interoperability, FDA will not regulate medical device data systems

The FDA will not regulate medical device data systems (MDDS), medical image storage devices and medical images communication devices, citing the need for more interoperability with health IT systems.

In a guidance issued Monday, the agency’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research said they made the decision on such devices “due to the low risk they pose to patients and the importance they play in advancing digital health.”

MDDS, which include software for transfer and display of data from medical devices and are not medical devices in and of themselves, the FDA explained. “An MDDS does not modify the data, and it does not control the functions or parameters of any connected medical device. An MDDS does not include devices intended for active patient monitoring,” the guidance explained.

In 2011, FDA reclassified medical device data systems as Class I (low-risk) technology from the high-right Class III. “Since down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public. Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices and medical image communications devices,” the new guidance said.

The recommendations are considered nonbinding, however, so the FDA reserves the right to change its policy in the future.