On Oct. 6, the FDA announced its recognition of a key consensus standard to support device sponsors as they address cybersecurity concerns. ANSI/AAMI SW96:2023 Standard for medical device security - Security risk management for device manufacturers. Published by the American National Standards Institute, Inc, and the Association for the Advancement of Medical Instrumentation, it aligns with existing international safety risk management standards and quality systems expectations.
It also provides direction to sponsors on how to consider and address cybersecurity risks in device design and development. FDA encourages the use of this new standard to enhance quality and support product performance.
FDA has the Recognized Consensus Standards: Medical Devices.