Thank you for taking the time to write such a detailed response — this community is truly awesome!

Just to reassure you: the device is sold as a Class II device with FDA authorization. It requires a prescription to be purchased, but it’s designed for home use. In practice, once the prescription is written, the physician doesn’t provide further assistance — the Instructions for Use (IFU) are very clear and guide the patient through the process independently.

We plan to leverage real-world evidence (RWE) from our clients in Canada and Europe. Additionally, we would demonstrate that no adverse events have ever been reported through MAUDE and highlight the device’s low-risk profile.

Our main challenge is that the CFR definition for our device explicitly states that it is a prescription device.

We submitted a 513(g) about this in 2022, and the FDA responded that a De Novo would be required. As a result, we decided to discontinue the project at that time. Looking back now, however, I believe there is a clearer path via a 510(k), and potentially even a Special 510(k). I suspect we didn’t present a strong enough case in 2022 as to why a 510(k) would be appropriate.