On 25 May 2026, the United States Food and Drug Administration (FDA) updated its Recognized Consensus Standards database by adding Supplementary Information Sheet (SIS) FR Recognition List Number 066 for ISO 10993-1 Sixth Edition (2025-11), covering biological evaluation of medical devices within a risk management process. The standard outlines requirements and general principles for assessing biological safety of medical devices that directly or indirectly contact patients or other users, including products intended for personal protection such as medical gloves and surgical masks. According to the FDA, the recognition is partial, with specific exclusions including the phrase “consumer products or” in Clause 6.5.11.3 and Clause 6.9 on biological risk estimation due to conflicts with existing FDA guidance and ISO 14971:2019. The agency noted that ISO 10993-1:2025 supports biological safety evaluation throughout a device’s lifecycle, from design and development through use and eventual withdrawal. FDA further confirmed that recognition of ISO 10993-1 Fifth Edition (2018) will transition to the Sixth Edition, with declarations of conformity to the earlier edition accepted until 1 July 2029. The update supports FDA’s current regulatory and scientific evaluation framework for medical devices
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