Device Makers Looking to FDA for Direction on Cybersecurity

Medical device manufacturers grappling with a multitude of cybersecurity issues await final direction from the federal government on better protecting patients and managing risk.

The comment deadline is March 18 for the Food and Drug Administration’s draft premarket cybersecurity guidance. The proposed guidance provides updated recommendations for device manufacturers on how they can better protect their products from risks like ransomware or a catastrophic attack on a health system.

“The real challenge is we talk about medical devices as if they were one thing, like they were chairs before us and they all serve the same function when ...