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FDA Updates Recognized Consensus Standards Database with List 61

The U.S. Food and Drug Administration (FDA) has released List 61 which is an update to the Recognized Consensus Standards Database. It includes new standards, updated versions, and revisions to the extent of recognition for existing standards.

Facts About This Update

One significant addition is ANSI/AAMI SW96:2023 Standard for Medical Device Security – Security Risk Management for Device Manufacturers that focuses on medical device security. This key consensus standard addresses cybersecurity concerns and aligns with international safety risk management standards and provides crucial direction for manufacturers in managing cybersecurity risks in device design.

Why Is This Important?

List 61 also contains updates to new versions for two existing standards, and revisions to the extent of recognition for three existing standards under the Accreditation Scheme for Conformity Assessment (ASCA).

The FDA plans to publish the next Federal Register notice in 2024. Meanwhile, manufacturers are encouraged to cite these changes in their submissions while aligning with FDA guidance on voluntary consensus standards.


Recognized Consensus Standards: Medical Devices

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