The FDA added the UL 2900 cybersecurity standard for medical devices to its list of recognized standards. The standard covers assessments of network-connectable devices for malware, software limitations and vulnerabilities.
Medical device applicants may now include their conformity with the standard as part of their registration in the U.S. market.
The standard reflects consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements, the agency said, in an Aug. 21 Federal Register notice.
The notice includes several updates and corrections made to the list of existing recognized standards, which the agency will continue to modify at least once a year.
Read the full list here: www.fdanews.com/08-24-17-UL2900Standard.pdf.