Key Steps To Prepare for FDA's New Medical Device Cybersecurity Rules

Recent changes to U.S. Food & Drug Administration (FDA) policy are now requiring all medical device manufacturers to implement cybersecurity measures to protect patients from cyberattacks.

With the passage of the Consolidated Appropriations Act of 2023, the FDA is now required by law to include cybersecurity in its review of certain medical devices that contain software and connect to the internet. Given that FDA approval is required prior to market most new devices, this new rule puts the FDA at the forefront of cybersecurity for device manufacturers.

The healthcare and life sciences spaces are no strangers to cyberattacks, and the FDA has been concerned about the cybersecurity of medical devices for nearly a decade. The administration's concerns stem from fears that cybercriminals could hack into internet-connected medical devices and compromise the ability of these devices to function, potentially causing life-threatening physical harm to patients.