Is a US-based test dataset mandatory for FDA clearance of dental AI software?

Question

At our company, we are developing dental AI software and are preparing for FDA clearance in the US. We understand that having data from US sources is beneficial, but is it always mandatory? Our product does not pose severe risk to patients or users. We would like to hear from those who have experience with FDA submissions for AI medical devices, especially regarding the origin of your test datasets and FDA expectations.

Dr. Oliver Eidel · Accepted Answer

In my experience, the FDA never explicitly stated what was wrong with our non-US clinical data, but they strongly suggested we include at least one US site in a multicenter study. They raised concerns about factors like skin color and obesity, but conceded these weren't relevant after discussion and review of our data. We referenced ISO 14155 to explain our protocols, even though our data was historical. Overall, US data was not officially mandatory, but there was significant pressure to include it, especially for non-US manufacturers.

Answer

From what I've heard from FDA experts, using a US dataset is good but not strictly necessary, unless there are population-dependent safety or efficacy concerns. It's important to address these concerns in your pre-submission to the FDA and justify your data sources.

Answer

We were more or less required to use a US dataset due to differences in acquisition protocols, patient characteristics, equipment, and reading protocols. However, our device's indication was quite different from dental AI, so your experience may vary.

Answer

From my two 510(k) applications (not for active devices), I saw that the process was much faster for a US manufacturer using the same data and indication. As a non-US manufacturer, we faced far more questions and were eventually forced to withdraw our application. It feels like the FDA is more protective of the US market and demands more from non-US manufacturers, regardless of the scientific rationale.

Is a US-based test dataset mandatory for FDA clearance of dental AI software?

4 Answers

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