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FDA Issues Long-Awaited Guidance On Device Security For Premarket Submissions, Seeks Industry Feedback

The US agency says increasing threats require an updated approach

 
• By Brian Bossetta

The US FDA’s 8 April draft guidance on device security replaces the agency’s 2018 guidance on the topic to better meet current cyber challenges.

Cybersecurity Concept
• Source: Alamy

While the US Food and Drug Administration addressed cybersecurity in premarket submissions in 2014 and then again with an updated guidance in 2018, the agency now says an “updated approach” is needed to meet the demands of heightened cyber risks.

Issued on 8 April, the FDA’s new draft guidance, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” replaces its 2018 guidance on the topic to...

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