FDA Finalizes Guidance Just as New Device Cyber Regs Kick In

Starting Oct. 1, Agency to Require Secure Dev Framework, Threat Modeling, SBOMs
The FDA has issued final guidance on how medical device makers should approach cybersecurity in their products to meet new requirements for including cyber details in their premarket product submissions. Starting Oct. 1, the FDA will "refuse to accept" submissions lacking those details.

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