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FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 
• By Brian Bossetta

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

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The US Food and Drug Administration published a revised final guidance document on June 26 offering cybersecurity recommendations for medical device makers.

The document — “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” —...

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