FDA updates Guidance on ISO 10993-1 and biological evaluation

FDA has updated the guidance to assist industry in preparing premarket applications and notifications for medical devices that come into direct contact or indirect contact with the human body.

Published in September 2020, the FDA guidance document on ISO 10993-1 incorporates several new considerations, such as the use of risk-based approaches to determine if biocompatibility testing is needed and recommendations for chemical assessment. Furthermore, it includes recommendations for biocompatibility test article preparation for devices with nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials.

The ISO standard 10993-1 concerns "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process”.

For more information on biological evaluation, please contact:

Brian Svend Nielsen
Tel +45 4516 9140