FDA recognized the 2025 revision of ISO 10993-1 in May 2026, with one carve out. Clause 6.9, which covers biological risk estimation, is only partially recognized. The agency said the new text lacks specificity for implementation and does not line up with ISO 14971:2019.
Shuliang Li, a senior standards advisor at FDA, said the agency is not asking for biological risk estimation under clause 6.9 in marketing submissions. A submission that follows the rest of the 2025 standard and leaves that clause alone is on solid ground today.
The revision adds terms including intermittent contact, bioaccumulation and reasonably foreseeable misuse. It also recategorizes devices by contact duration and tissue type, and it tightens the link to ISO 14971. FDA has not updated its own biocompatibility guidance for any of it. CDRH refreshed its biocompatibility resource center and test report guidance on September 9.
For a startup writing a biological evaluation plan this quarter, the workable answer is to test to the 2018 categorization and cite the 2025 version where it helps. FDA is running town halls on extractions September 23 and on toxicological risk assessment October 7.