New version of the FDA guidance on the use of ISO 10993-1

The US Food and Drug Administration (FDA) has published an updated version of the guidance on the use of ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) to support medical devices application.

The guidance supersedes the version published in June 2016 that represented a major update of the previous guidance published in 1995. Changes in the 2020 version are not significant changes.

The most important information to mentioned, is that although published in September 2020, the FDA guidance still refers to the 2009 version of ISO 10993-1, and therefore not the most recent one. A new version of ISO 10993-1 was approved in April 2018, but has not yet been adopted as a European standard.

Changes introduced in ISO 10933-1: 2018 may not been considered in the FDA guidance. For examples, ISO 10993-1: 2018 introduced an additional category for devices with a duration of contact of less than 1 minute: the transitory-contacting devices, for which biocompatibility testing may not be necessary. This is not addressed in the FDA guidance.

However, ISO 10993-1: 2018 used the FDA modified matrix for updating the biocompatibility evaluation endpoints to consider. The two matrixes now look really similar and manufacturers who have followed ISO 10993-1: 2018 for the development of their biocompatibility testing programme, may not have to perform additional testing before submission to FDA.

The guidance is accessible here.