FDA Issues Draft Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.

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the final guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” and issued a draft guidance of the same name. This draft guidance replaces the 2018 draft version and is intended to further emphasize the importance of ensuring that devices are designed securely, enabling emerging cybersecurity risks to be mitigated throughout the Total Product Life Cycle, and to outline the FDA’s recommendations more clearly for premarket submission content to address cybersecurity concerns.

Read the Draft Guidance

Facts about the draft guidance

This guidance, when finalized, is intended to:

• Provide recommendations to industry on cybersecurity considerations for devices.
• Help industry identify issues related to cybersecurity in the design and development of their medical devices.
• Provide recommendations for documentation in device premarket submissions.

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance

This draft guidance will be open for public comments for 90 days at www.Regulations.gov under docket number FDA-2021-D-1158.

Questions?

If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.