FDA names its first medical device cybersecurity director - Fierce Biotech

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According to the article:

"The FDA has appointed its first medical device cybersecurity chief to help guide the agency’s regulatory strategies as more devices become interconnected—and potentially more vulnerable to digital attacks and breaches.

Kevin Fu, an associate professor and research fellow at the University of Michigan, was named to the post. He will serve a one-year term as an expert-in-residence at the agency’s Center for Devices and Radiological Health (CDRH) as well as at its nascent Digital Health Center of Excellence, which launched last fall."

Read the full source article:  FDA names its first medical device cybersecurity director - Fierce Biotech

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FDA outlines cybersecurity recommendations for medical device manufacturers

Read the full article:  Press Announcements > FDA outlines cybersecurity recommendations for medical device manufacturers - FDA.gov:

"The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market. The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats."

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Read the FDA draft guidance:
Postmarket Management of Cybersecurity in Medical Devices (PDF)

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The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov

Read the full press release:  Press Announcements > The FDA takes steps to strengthen cybersecurity of medical devices - FDA.gov:

"To strengthen the safety of medical devices, the U.S. Food and Drug Administration today finalized recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information.

The final guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” recommends that manufacturers consider cybersecurity risks as part of the design and development of a medical device, and submit documentation to the FDA about the risks identified and controls in place to mitigate those risks. The guidance also recommends that manufacturers submit their plans for providing patches and updates to operating systems and medical software."

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