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on “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability”.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 28^th, 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.

Bills Introduced – 9-24-20

Yesterday, with both the House and Senate in session, there were 107 bills introduced. Two of those bills may receive additional coverage in this blog:

HR 8379 To require the Director of the Cybersecurity and Infrastructure Security Agency to establish cybersecurity guidance for small organizations, and for other purposes. Rep. Eshoo, Anna G. [D-CA-18]

S 4731 A bill to require the Director of the Cybersecurity and Infrastructure Security Agency to establish cybersecurity guidance for small organizations, and for other purposes. Sen. Rosen, Jacky [D-NV]

I suspect that these are companion measures with nearly identical language. I will be watching both bills for definitions and language that would include requirements for guidance on control system security, but I am not holding my breath.

Bills Introduced – 8-11-20

Yesterday with the Senate in Washington (or at least pretending to be) and the House meeting in pro forma session there were 39 bills introduced. One of these bills may receive additional coverage in this blog:

HR 7998 To require the Director of the National Institute of Standards and Technology to disseminate guidance to institutions of higher education and non-profit research institutions to help mitigate cybersecurity risks to COVID-19 related research, and for other purposes. Rep. Barr, Andy [R-KY-6] 

I will be watching this bill for language or definitions that would pertain to the cybersecurity of laboratory equipment or management systems, the lab equivalent of industrial control systems. Not expecting much but watching for it just the same.