Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act." This draft guidance proposes select updates to the final guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions." This draft guidance, when finalized, will identify the information FDA generally considers to be necessary for cyber devices to support obligations under the new amendments to the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 (FD&C Act) for ensuring cybersecurity of devices. This draft guidance is not final nor is it for implementation at this time.