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  • Writer's pictureJL Tox Consulting

FDA Partially Recognizes ISO 10993-23:2021

On June 7th, the U.S. FDA partially recognized ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation



The following parts of the standard were not recognized:

-Clause 4 (General principles - Step-wise approach),

-Clause 6 (In vitro irritation tests),

-Annex B (Test method check list for in vitro irritation testing using reconstructed human epidermis models)

-Annex C (Example of method documentation sheet for reconstructed human epidermis models)


This partial recognition aligns with the U.S. FDA's long standing preference for in vivo irritation testing despite the shifts in the EU to recognize the use of alternative in vitro irritation tests.

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