New Guidance on FDA ISO 10993-1

Authority

Authority

Author: James Morrison

On 4 September 2020 FDA re-issued their guidance on the use of ISO 10993-1 and Biocompatibility.

I don’t think anyone saw this coming. It’s a big surprise!

But the good news is that it is unlikely that this will change anything. It’s really just a clarification.

This was a minor update to include FDA’s Center for Biologics Evaluation and Research (CBER) explicitly on the cover of the guidance in addition to Center for Devices and Radiological Health (CDRH), since the guidance already applied to CBER-regulated devices and combination products with a device constituent part. There are also some administrative updates, such as correction of broken links and edits to reflect the Office of Product Evaluation and Quality (OPEQ) reorganization.

This won’t change the way FDA considers the use of the ISO standards, or the way it wants to see Biocompatibility evaluated in submissions. And certainly there are no technical changes.

But if you are still wondering how to make good use of this complex document, or you are at all uncertain of how to conduct a Biological evaluation on a medical device or combination product, then please reach out to us at Brandwood CKC.

Reference: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and

We tailor our services to the requirements of your business and can help you implement plans that are best suited to your projects. Contact us now to discuss your needs and how we can help.Contact us

Disclaimer:

The contents of this article/presentation are solely the opinion of the author and do not represent the opinions of PharmaLex GmbH or its parent AmerisourceBergen Corporation. PharmaLex and AmerisourceBergen strongly encourage readers/listeners to review available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto.

Scroll to Top