The guidance recommends manufacturers conduct appropriate verification, validation and risk management processes as well as specify medical devices’ functional, performance and interface characteristics to users.
“It’s not likely that medical device interoperability is a part of the everyday vocabulary of American consumers — and frankly, we hope it stays that way,” wrote Bakul Patel, associate director for digital health at the FDA’s Center for Devices and Radiological Health, in an FDA blog post. “We want patients and consumers to have confidence that medical devices work as intended without concern over how these devices operate together.”
The guidance also clarifies what information device manufacturers should include in premarket submissions.
Click here to view the full guidance.
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