Doing a 510(k) to go from RX to OTC

[Mtmrlt]

Hello everyone,

I’ve seen several people here ask about using the 510(k) pathway to change a device from prescription-only to over-the-counter (OTC) status.

Our device is already intended for at-home use by laypersons, so we plan to use our own product as the predicate.

Has anyone here successfully gone through this pathway, or does the FDA always require a De Novo instead?

Thank you in advance for sharing your experience!

 

[shimonv]

I've worked with a company that made the transition for Rx to OTC through 510(k).
If it's the same intended use then there shouldn't be a problem with moving away from OTC to Rx, which less challenging because the user is healthcare professional.

The De Novo path is intended for novel devices where there is no existing product code for them.

Shimon

 

[Mtmrlt]

Dear Shimonv,

Thank you for your response — I truly appreciate it! I also greatly appreciate all your previous insights on this matter.

Just to confirm: were there any predicate devices that were already classified as OTC, or were they all prescription (Rx) devices?

Also, did the CFR definition of your device specifically indicate that it was a prescription device? That’s the part that concerns us — the CFR definition for our device explicitly states that it is a prescription device.

We submitted a 513(g) in 2022, and the FDA responded that we needed to pursue a De Novo. Because of that, we ended up dropping the project. Looking back now, I see a clearer path via a 510(k), and potentially even a Special 510(k). I have a feeling we didn’t explain ourselves clearly enough when we submitted our 513(g).

Thanks again for all your help!