By Jayet Moon
The U.S. Food and Drug Administration (FDA) has issued its much-anticipated final guidance on cybersecurity risk management in medical devices, effective June 2025. This document, titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions,” marks a major milestone in aligning medical device cybersecurity with regulatory expectations, emphasizing safety, effectiveness, and life cycle security.
Defining A “Cyber Device”
Everything in this guidance applies to “cyber devices.” There is some confusion on what exactly this means. Let’s clarify that in FDA’s own words:
FD&C Act defines a “cyber device” as a device that:
- includes software validated, installed, or authorized by the sponsor as a device or in a device;
- has the ability to connect to the internet; and
- contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats
Informed in part by the definitions recognized by NIST for the term “software,” the FDA considers a “cyber device” to include devices that are or contain…
