We've been developing a wearable, which is classified as a medical device, so we've been looking at the FCC/CE/etc regulations for a while.

We're using ESP32s, and are currently going through ethics approval, which, from what I understand, means we can use the device prior to sale, but maybe we've got that wrong. I can't imagine having to have each hardware iteration certified by the FCC.

What struck me more about this article is the subject of marketing.

For companies that are doing pre-sales, and are still in development, and likely haven't been certified yet. Isn't that considered marketing? How are other companies handling this? We're looking to run a marketing trial in a few months, and marketing is part of the recruitment process for a trial.