New Guidance on FDA ISO 10993-1
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.
We offer deep support for navigating international regulatory processes. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Reach out today and start a conversation. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)
The views and options expressed in this article are those of the author/s and do not necessarily reflect the views of Brandwood CKC Pty Ltd ACN 128 762 505.
The information presented in this article is of a general nature only and does not consider the particular circumstances of your business. Prior results and case studies do not guarantee a similar outcome in future. You should not rely on this information, and you should seek specific advice for your particular business needs.
Where indicated, certain content has been sourced from third parties; we have not independently verified it. Neither Brandwood CKC nor the author makes any warranty as to the accuracy, completeness or reliability of this article, nor do those parties accept any liability or responsibility arising in any way from omissions or errors contained in the content.