On January 14, 2019, the FDA announced recognition (partial) of ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
In the Supplementary Information Sheet (SIS), it was noted that the FDA does not recognize Table A.1 in Annex A of the standard as it is in conflict with the FDA’s guidance “Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (14 Sept 2016).” The most notable differences between the ISO standard Table A.1 and the FDA guidance Table A.1, are that the FDA guidance Table A.1 does not include a column for “Physical and/or chemical information” and does include “Material-mediated pyrogenicity” as an endpoint for consideration for medical devices in contact with mucosal membranes for greater than 24 hours.
The FDA notes that declarations of conformity, in support of premarket submissions, to the old standard will be accepted until 26 December 2020. For more information on the FDA’s Standards and Conformity Assessment Program, visit the FDA website, located here.
If you would like to learn more about the changes incorporated in ISO 10993-1:2018, or to speak to a member of our team about how this might impact your biocompatibility testing strategy, feel free to drop us an email. Our toxicology consulting team is ready to support you!