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FDA Proposes New Cybersecurity Submission Standards For Devices

The agency issued a draft guidance and safety communication last week in response to a recent emergence of cybersecurity breaches occurring in wirelessly connected medical devices in hospitals.

Device companies would be expected to more directly address potential cybersecurity threats in pre-market submissions under a FDA draft guidance released June 13.

The agency issued the guidance in conjunction with a safety communication to hospitals and device makers on appropriate safeguards to prevent against cyber-attacks on devices. On the same...

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