• Summary
• Background
• Webinar Materials

Summary

On Tuesday, April 30, 2024, the U.S. Food and Drug Administration (FDA) held a webinar to discuss the draft guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.

Background

This draft guidance proposes updated recommendations to industry on cybersecurity considerations for cyber devices and for documentation in device premarket submissions. The Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, in its current form, remains the Agency's current thinking on this topic until this draft guidance is finalized, at this time the finalized version of Section II. of this draft guidance will be added as Section VII. of the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.

Webinar Materials

The presentation, printable slides and transcript are available on CDRH Learn End of
Translation under "Specialty Technical Topics", sub-section "Digital Health" as well.

If you have questions about this guidance document, please contact the CDRH Digital Health Center of Excellence at digitalhealth@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.