Regulatory Update: ISO 10993-1 Set for Major Revision

A new edition of ISO 10993-1, the cornerstone standard for biological evaluation of medical devices, is nearly here. The standard has moved from the “in voting” phase to “under publication,” meaning it has been formally approved and is expected to be released within the next seven weeks. ISO 10993-1:2025 listing

This upcoming release is anticipated to bring substantial updates. Once published, the FDA will initiate its recognition process, which typically concludes within a few months. Upon recognition, sponsors may begin referencing the new version in premarket submissions.

Importantly, the FDA traditionally allows a 12–18 month transition period, during which both the outgoing (2018) and incoming (2025) versions may be used, provided the approach is justified and documented. This provides manufacturers and test labs with time to review changes, update procedures, and ensure alignment without disrupting active development efforts.

At Polaris Biomedical, we are closely monitoring these developments. For in-flight programs, this transition should pose no regulatory risk provided submissions are made before the end of the FDA’s transition window. Once the new version is published, Polaris Biomedical can help prepare a formal gap analysis that highlights key changes and provides recommendations for adopting the revised standard.

Stay tuned for a detailed summary once the final version is available.

Polaris Biomedical helps medical device companies navigate regulatory change with confidence. If you need support evaluating standards updates or adjusting your biocompatibility strategy, we’re here to help.