New Guidance on FDA ISO 10993-1



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.


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