FDA Finalizes Guidance on Use of ISO 10993-1 in Evaluation of Biocompatibility of Medical Devices
October 3, 2020 at 11:37 PM EST
The FDA has finalized guidance on the use of an international standard on preparing biocompatibility evaluations intended to support marketing applications submitted to the agency for new or modified medical devices that come into direct or indirect contact with the human body.
The final guidance — “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical ... Read More
