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FDA Issues Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act

Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. This draft guidance proposes updated recommendations to industry on cybersecurity considerations for cyber devices and for documentation in device premarket submissions.

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance

Submit comments under docket number FDA-2021-D-1158 at www.regulations.gov by May 13, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

Upcoming webinar on this guidance

On April 30, 2024, the FDA will host a webinar for those interested in learning more about the guidance.

Questions?

If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.