Cybersecurity Policy Report, MEDICAL DEVICES—FDA GUIDANCE NOTICES: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, (Mar 13, 2024)

By WK Editorial Staff

The FDA is announcing the availability of the draft guidance entitled “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.”

This draft guidance proposes select updates to the final guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” This draft guidance, when finalized, will identify the information FDA generally considers to be necessary for cyber devices to support obligations under the new amendments to the Federal Food, Drug, and Cosmetic Act (FDC Act) for ensuring cybersecurity of devices. This draft guidance is not final nor is it for implementation at this time. (Notice, 89 FR 18421, March 13, 2024).

Dates. Submit either electronic or written comments on the draft guidance by May 13, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

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