FDA updates cybersecurity guidance for medical device makers
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
The AHA provided comments Sept. 30 to the Senate Homeland Security and Governmental Affairs Subcommittee on Disaster Management, District of Columbia and…
Headline
The FBI Sept. 29 announced an arrest of one of the alleged leaders of ShinyHunters, a cybercriminal group linked to cyberattacks in the U.S. and…
Headline
The FBI and the Cybersecurity and Infrastructure Security Agency have released a fact sheet for critical infrastructure organizations on ways to reduce risk…
Headline
The AHA will host a webinar Sept. 30 at 1 p.m. ET on ways healthcare organizations can build an effective, closed-loop cybersecurity program designed…
Headline
New guidance from the Cybersecurity and Infrastructure Security Agency encourages healthcare organizations to consider internal network and internet facing…
Headline
The National Institute of Standards and Technology and the Cybersecurity and Infrastructure and Security Agency have released guidelines to protect…