What if I already submitted my cyber device?

This was pulled from the FDA Cybersecurity in Medical Devices - Frequently Asked Questions on October 12, 2023:

As provided by the Omnibus, the cybersecurity requirements do not apply to an application or submission submitted to the Food and Drug Administration (FDA) before March 29, 2023. If a cyber device was previously authorized, and the manufacturer is making a change to the device that requires premarket review by the agency, the law would apply for the new premarket submission.

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