Thursday, February 29, 2024

FDA Sends New Premarket Cybersecurity Guidance Notice to OMB

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received a notice from the Food and Drug Administration (FDA) on “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability”. Such notices are not normally published in the Unified Agenda, so we have no guidance on what this new guidance may contain other than it almost certainly deals with medical device cybersecurity.

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