FDA Adds UL 2900 Cybersecurity Standard to Recognized Medical Device Standards
The FDA has added the UL 2900 cybersecurity standard for medical devices to its list of recognized standards.
The UL 2900 standard addresses cybersecurity requirements for devices that can connect to networks. Medical device applicants may now include their conformity with the standard as part of their registration in the U.S. market.
The standard covers assessments of network-connectable devices for malware, software limitations and vulnerabilities.