On March 12, the FDA issued the draft guidance “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” Which includes select updates to the FDA guidance document “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (aka, Premarket Cybersecurity Guidance). FDA is proposing to add a Section VII. to the Premarket Cybersecurity Guidance to address new considerations for cyber devices. The new section identifies the cybersecurity information FDA considers to generally be necessary to support obligations under section 524B of the FD&C Act, “Ensuring Cybersecurity of Devices.”

The Premarket Cybersecurity Guidance, in its current form, remains the agency’s current thinking until the new draft guidance is finalized, at which time the finalized version of Section II. of this draft guidance will be added as Section VII. of the Premarket Cybersecurity Guidance.

The draft guidance covers:

• Who is required to comply with 524B of the FD&C Act
• Devices Subject to Section 524B of the FD&C Act
• Documentation Recommendations to Comply with 524B

Stakeholders may submit comments under docket number FDA-2021-D-1158 at www.regulations.gov by May 13, 2024. On April 30, 2024, the FDA will host a webinar for those interested in learning more about the guidance.

Download the draft guidance here.