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FDA Sticks With Premarket Plans In Cybersecurity Guidance

A final guidance issued by the agency on premarket submission content to support device cybersecurity is consistent with last year’s proposal. FDA was not swayed by calls to allow device firms to address cybersecurity risks and mitigation efforts within design history files rather than in premarket submissions.

FDA issued final recommendations to device firms for incorporating cybersecurity testing, data and mitigation efforts into premarket submissions for new devices in advance of a public meeting on the topic planned for later this month.

The agency’s final guidance on the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” (FDA-2013-D-0616)...

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