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FDA Updates Its Recognized Standards List

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and authorization of medical devices.

In a Notice published in the Federal Register in early March, the agency announced 20 additions and 53 modifications to the list of FDA Recognized Consensus Standards. Notable among the new standards added to the list are ISO/IEC/IEEE 29119-1 Second edition 2022-01, dealing with software testing, and ANSI/AAMI SW 96:2023, which details requirements for security risk management for device manufacturers.

Also newly added to the list of recognized standards is ANSI/AAMI ST 108:2023, which addresses water quality for processing medical devices.

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Read the updated Recognized Standards list as published in the Federal Register.

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