Friday, March 8, 2024

OMB Approves FDA Premarket Cybersecurity Guidance Notice

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a notice of availability from the 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on “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability”. This guidance was submitted to OIRA on February 28th, 2024.

As with most guidance documents, this was not listed in the latest version of the Unified Agenda.

This notice will likely appear in the Federal Register within the next couple of weeks. There have been some unusual delays in these publications due to the large volume of rulemakings being processed by the Biden Administration.

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