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Cybersecurity Guidance Update Lays Out ‘Cyber Device’ Rules

 
• By Elizabeth Orr

Draft guidance from the US Food and Drug Administration details what the agency wants to see to demonstrate cybersecurity in connected devices during premarket submissions. 

Cybersecurity
• Source: Shutterstock

A draft update to the US Food and Drug Administration’s guidance document on premarket regulation of medical device cybersecurity clarifies the agency’s expectations around establishing cyber threat protection in submissions for so-called “cyber devices.”

When finalized, the document will become the new Section VII of a guidance document last updated in September 2023....

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