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FDA Issues Guidance on Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act

Today, the U.S. Food and Drug Administration (FDA) issued a guidance for immediate implementation: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act.

The FDA generally intends not to issue “refuse to accept” (RTA) decisions for premarket submissions for cyber devices that are submitted before October 1, 2023, based solely on information required by section 524B of the FD&C Act. Instead, the FDA will work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process.

For more information about cybersecurity in medical devices, read Cybersecurity in Medical Devices Frequently Asked Questions (FAQs).

Questions?

If you have questions about this guidance, contact the Division of Industry and Consumer Education.