Labeling & Transparency: Cybersecurity

Labeling documentation plays a critical role in helping device users understand cybersecurity risks and protections. Yet, medical device manufacturers often face challenges interpreting labeling guidance and preparing documentation that satisfies both regulatory expectations and customer demands for transparency.

By examining commonly used labeling documents—such as Software Bill of Materials (SBOMs), Security Whitepapers, Instructions for Use (IFUs), and Manufacturer Disclosure Statement for Medical Device Security (MDS²) forms—and clarifying their role in supporting cybersecurity communication, this project seeks to improve the transparency, usability, and regulatory requirements of cybersecurity labeling for medical devices.

Members will collaborate on best practices for maintaining labeling updates and improve alignment with stakeholder expectations through a Framework intended to guide manufacturers in creating effective labeling documentation.