FDA backs off regulating medical device data systems

The Food and Drug Administration is treating the data systems and IT infrastructure that capture information from medical devices as low-risk, as a way to encourage innovation.

 Shutterstock image: global health.

The data systems that carry and store information from medical devices like blood pressure readers and glucose monitors are being tagged as low-risk by the Food and Drug Administration so they do not have to comply with regulatory controls, according to a new FDA policy guidance issued June 20.

The guidance doesn't 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.

Mostly, the guidance is designed to alert manufacturers and developers of apps and systems that use historical medical data -- such as output information from a ventilator  or the display of stored medical images -- that concerns about regulation shouldn’t slow down product innovation.

"Because they pose such a low risk, FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems. FDA believes that this will encourage greater innovation in the development and maturation of these systems," Bakul Patel, a senior policy advisor at FDA's Center for Devices and Radiological Health, wrote in a blog post.

FDA's guidance gives some long-sought regulatory clarity for companies such as Apple and Samsung that are looking to make health apps an integral feature of their mobile offerings and a new generation of wearable computing devices.

Under the new policy, apps 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 move is in keeping with an April report from the FDA, the Federal Communications Commission, and the Office of the National Coordinator of Health IT, which proposed a risk-based approach to government regulation of the new generation of health IT data products. The stated goal of the approach was to give developers room to experiment, innovate and pivot without the long lead times required for medical device approval.

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