• Summary
• Background
• Meeting Materials

Summary

The U.S. Food and Drug Administration (FDA) is announcing a webinar for stakeholders to share information and answer questions about the draft guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

During this webinar the FDA will:

• Describe the differences between 2018 and 2022 drafts
• Describe the General Principles of the guidance
• Describe the design and documentation recommendations
• Describe the transparency and labeling recommendations

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Background

As medical devices have become more interconnected, cybersecurity threats have become more numerous, more frequent, more severe, and more clinically impactful. As a result, adequate medical device cybersecurity is essential to ensuring medical device safety and effectiveness. In 2018, the FDA proposed updates to the final guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” and issued a draft guidance of the same name. This 2022 draft guidance replaces the 2018 draft guidance. This draft guidance is intended to further emphasize the importance of ensuring that devices are designed securely, are designed to be capable of mitigating emerging cybersecurity risks throughout the Total Product Life Cycle, and to more clearly outline the FDA's recommendations for premarket submission content to address cybersecurity concerns.

Meeting Materials

Printable Slides

After the webinar, the presentation, printable slides, and transcript will be available at CDRH Learn under "Specialty Technical Topics", sub-section "Digital Health."

Comments

Please submit your comments regarding this draft guidance to https://www.regulations.gov, Docket No. FDA-2021-D-1158 by July 7, 2022.

The resulting discussions from the meeting and comments received in the docket will be taken into consideration.

Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at http://www.regulations.gov.