FDA Updates Recognized Consensus Standards Database with List 61

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FDA Updates Recognized Consensus Standards Database with List 61

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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.

Reference

Recognized Consensus Standards: Medical Devices

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Starting your journey towards meeting with the FDA regulatory requirements? Let Celegence assist you. Reach out to us today to explore the possibilities of partnering with Celegence’s regulatory team. For more information reach out to us at info@celegence.com, contact us online or learn more about our service offering on our services page.

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