On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices and medical image communications devices, due to the low risk they pose to patients. The guidance, titled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices,” is a clarifying follow-up to the January 2011 regulation that down-classified medical device data systems. In a blog released along with the publication, Bakul Patel, senior policy adviser for FDA’s Center for Devices and Radiological Health, wrote that since 2011, “…FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public.” Mr. Patel further expressed that “[t]oday, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced.”
Medical device data systems are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices. According to the draft guidance, medical device data systems do not aim to control or “alter the functions … of any connected medical devices,” but rather are intended to:
• Facilitate electronic transfer or exchange of medical device data;
• Store and retrieve medical device information, such as blood pressure data;
• Convert medical device data from one format to another; and
• Display medical device information
As a result of FDA’s draft guidance, medical device data systems — such as software that collects data from a glucometer or a weight scale — no longer will have to comply with FDA rules. The guidance does not, however, apply to systems engaged in active medical monitoring or systems that control the delivery of medicine or oxygen, or modify patient data. It’s meant to cover the storage, transfer, conversion and display of medical device data. Under the new policy, applications that are “used as a secondary display to a regulated medical device and are not intended to provide primary diagnosis, treatment decisions, or to be used in connection with active patient monitoring” meet the definition of the low-risk medical device data systems, and will not be treated as regulated devices under FDA rules.
The new draft guidance is consistent with the April 2014 report from the FDA, the Federal Communications Commission and the Office of the National Coordinator of Health IT, proposing a risk-based approach to government regulation of the new generation of health IT data products. In releasing this guidance, the FDA recognizes that medical device data systems are critical to the success of digital health and are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT. At the same time, the FDA recognizes that they pose low risk and thus the FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems. In doing so, the FDA believes that this will encourage greater innovation in the development and maturation of these systems. The draft guidance can be found here.