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Apr 13, 2021 Kelly Stanton

FDA Launches New Biocompatibility Assessment Resource Center

Are you trying to gauge the biocompatibility of your medical device for an upcoming audit or regulatory submission? 

If so, you’ll be happy to learn about the FDA’s newly launched Biocompatibility Assessment Resource Center, a site designed to help explain and clarify the most important terms and concepts outlined in the ISO 10993 standards that govern the biocompatibility of medical devices. 

In order to increase the chances that your device meets biocompatibility standards, the FDA recommends that you first read its Biocompatibility Guidance on Use of ISO 10993-1

Once you’ve done that, you need to follow the steps outlined in the new resource center, which we’ll briefly summarize next.

Step 1: Biocompatibility basics

The first step is understanding the basics of biocompatibility

According to the FDA, this involves knowing when biocompatibility information is needed, what and how the FDA assesses or evaluates biocompatibility, and the biocompatibility factors the FDA is interested in

At this point, you will also want to familiarize yourself with the glossary of biocompatibility terms so you are familiar with the lexicon you’ll be dealing with as you move closer to regulatory approval.

Step 2: Evaluation endpoints

Next, it’s time to take a look at biocompatibility endpoint tables, which the FDA provides by device category and by contact duration.

Step 3: Test articles

Here, you need to document how test articles compare to proposed medical devices

The FDA provides guidance on component documentation, device documentation, new processing and sterilization changes, and formulation changes.

Step 4: Test report

The final step in the process outlines what you should include in a test report

Learn about test reports, test article preparation, test parameters and acceptance criteria, analysis of results, and conclusions.

What else you need to know

After these four steps, the FDA recommends medical device manufacturers check out relevant device-specific guidance documents and Class II Special Controls Documents for additional information.

If you have any specific questions about biocompatibility, you’re able to send over a pre-submission to get feedback. Learn how to do that here. The FDA also encourages manufacturers that have general biocompatibility questions to drop them a line.

For more information on what you can do to ensure your medical device gets fast-tracked for approval, check this out.

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Published by Kelly Stanton April 13, 2021