FDA’s Cybersecurity Authority in 2023

On March 29, 2023, the FDA has issued a new final guidance on the Refuse to Accept (RTA) policy relating to cybersecurity in medical devices, specifically for “Cyber Devices” as defined in the newly-amended FD&C Act (Section 524B). In mapping its guidance to the new statutory authority, the FDA specifies what is expected when a submission is provided to the agency for review.

Regulatory

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