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FDA Recognizes ANSI/AAMI SW96:2023 Standard for Medical Device Cybersecurity


The Food and Drug Administration (FDA) has recognized the ANSI/AAMI SW96:2023 standard for medical device security and security risk management. Published by the American National Standards Institute and the Association for the Advancement of Medical Instrumentation, this standard aligns with international safety risk management standards (ISO 14971) and provides guidance to medical device manufacturers on addressing cybersecurity risks in design and development. The FDA encourages the adoption of this standard to enhance quality and support product performance. This standard is seen as operationally beneficial for hospitals and health systems, offering consistent security standards for evaluating cyber risks associated with new medical devices.


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