The Food and Drug Administration Sept. 26 finalized guidance updating the cybersecurity information device makers should submit to its Center for Devices and Radiological Health or Center for Biologics Evaluation and Research for premarket review of devices that have cybersecurity considerations. The recommendations are intended to help manufacturers meet their obligations under section 524B of the Federal Food, Drug, and Cosmetic Act, enacted in December 2022 as part of the Consolidated Appropriations Act of 2023, which defines “cyber device” as one that includes a device or software that can connect to the internet and be vulnerable to cybersecurity threats.

Related News Articles

Headline
John Riggi, AHA’s national advisor for cybersecurity in risk, participated July 18 as the opening keynote speaker in the Information Security Media Group’s…
Headline
A joint advisory issued the week of July 8 by the Cybersecurity and Infrastructure Security Agency, National Security Agency, FBI and several international…
Headline
The AHA July 2 submitted comments to the Cybersecurity and Infrastructure Security Agency on its proposed rule establishing reporting requirements for…
Headline
The Department of Health and Human Services Health Sector Cybersecurity Coordination Center June 27 issued an alert about a critical vulnerability in MOVEit, a…
Headline
A joint report released June 26 by the Cybersecurity and Infrastructure Security Agency, FBI, the Australian Cyber Security Centre and Canadian Centre for…
Headline
The Health Information Sharing and Analysis Center June 27 issued a threat bulletin alerting the health sector to active cyberthreats exploiting TeamViewer. H-…