Biocompatibility testing questions answered in pre-submission requests

The following is a copy of my responses to someone that submitted biocompatibility testing questions in preparation for the 510k pre-submission webinar that I am hosting Thursday, February 22 @ 4pm EST.

510k pre submission webinar February 22 for LinkedIn.jpg 1024x459 Biocompatibility testing questions answered in pre submission requests

Can you please answer the following biocompatibility testing questions?

This was the request by a person that registered for my live webinar next Thursday. The person asked some great questions that are very similar to other clients I work with. They also asked the biocompatibility testing questions in a way that did not divulge any confidential information–other than to indicate they live in Germany. Therefore, I am sharing my email response with you. Please register for this webinar and submit your own questions. Questions are entered in an open text box, and you have room to ask multiple questions.

1. Does the FDA now already ask for the AET (Analytical evaluation threshold) for chemical analyses?

I’m not an analytical chemist. That would be an awesome question for Thor Rollins at Nelson Labs. He is giving a 1-day workshop on bicompatibility testing on March 20:
Nelson Labs is offering a 1-day seminar the day before the 510(k) workshop on biocompatibility ($499):


2. How can I avoid time consuming genotox studies for FDA?

Typically if you perform the “Big 3” (i.e., cytotox, irritation and sensitization), and then you perform chemical characterization, you are often able to prepare a Biological Evaluation Report to explain why there are no identified compounds in the chemical characterization that would warrant performing the genotox studies. This is also often true for the acute toxicity testing and sub-chronic toxicity testing. In order to verify the FDA will accept this approach, you will typically provide a biological evaluation plan (BEP) as part of your pre-submission request. This often saves > $10K.


3. And how can I face FDA with a cytotoxic wound dressing but which passed irritation, sensitization, genotox and pyrogenicity tests?
I had a product that contained aluminum. Aluminum is cytotoxic to the cell line that is used in the cytotoxicity testing. However, aluminum does not have a high level of toxicity for the route of administration for that product. You should identify the reason why your product is cytotoxic and then provide an explanation why the device is no toxic for the intended use and duration of contact. This would normally be part of that BEP mentioned above.


4. Which genotox tests are state of the art for the FDA?
There are three ways to determine that. One is to look in the recognized standards database on the FDA website. Second is to review the FDA guidance on biocompatibility and application of ISO 10993-1. Finally, you can ask the FDA about the suitability of another test you want to perform during a pre-sub. If they prefer a different test, they will say so in an email response and they are available for discussion by conference call during the pre-sub meeting to clarify their response.


Note: I did not answer this question outright, because biocompatibility testing (and all verification testing) requirements change over time. In fact, for one 510k project I had 7 different standards change just prior to submission. During a pre-submission meeting, the FDA should make you aware of coming changes to these tests. Also, the better biocompatibility testing labs, such as Nelson Labs, are also aware of the changes before they are implemented. This is because personnel like Thor Rollins personally get involved in the revision of standards.


5. Will the meeting be recorded since I live in Germany?
Yes, all of my webinars are recorded. I will email you a link for downloading it and you will receive that email in the morning after the webinar. You can also schedule calls with me as a follow-up using the following link:



Future Related Events

In addition to the 1-day seminar by Thor Rollins on biocompatibility testing (March 20), we are also offering a 2-day 510k workshop at the same Embassy Suites Hotel in Las Vegas. The cost is $995 (discount for multiple attendees). Here’s the link for registration–or email and I can invoice your company.

Posted in: 510(k)

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