How to handle optional software feature that is part of a medical device, but not sold in the USA

Hello community,

We are planning to add a new software feature (a complex image processing algorithm) to our software product that is sold in Europe (under MDR) and in the US (under the FDA). The specific feature is bound to a dedicated license key.

We don't want to sell the feature/license key in the USA and only in the EU in the first step, so it should not be relevant to the FDA clearance process for the next version of our software product. Nevertheless, the feature is of course fully described in our technical documentation (functional specification, risk analysis, verification plan and report, etc.) that form the basis of for the clearance under MDR and FDA.

How should we set up our technical documentation and communication for the FDA clearance of our software product? Do we have to make two versions of the full technical documentation (one for FDA and one for MDR) or is there a lean alternative?

Thank you all!
Thorsten

 

Ultimately, I think you're going to have to say the feature is not available in the US. Probably a good topic for a pre-sub. You'd have to state an approach, you can't just ask them what the right approach is.