Medical Device-OTC and RX

[Priyanka]

Hi All,

We are a new medical device startup and are in the process of preparing our first 510(k) submission for our medical device. I have a query regarding the medical device type of use.

Is it possible for a medical device to be classified as both prescription (Rx) and over-the-counter (OTC)? And if so, does the FDA accept this dual classification? Additionally, could you provide any specific guidelines or regulations that manufacturers should adhere to when seeking such a classification for their medical devices?

 

[Emma2010]

Hi Priyanka,

I did find some medical devices that are both Rx and OTC use cleared under a single 510(k), such as K191151 but under different intended use (so as to meet the definition of Rx and OTC, I suppose). Meanwhile, you have to label the device separately to avoid misbranding as FDA indicates that "It could also be selling a device over the counter that requires a prescription labeling. That's misbranding, and that's prohibited under the federal Food, Drug and Cosmetic Act."

I hope this can be somewhat helpful.
Regards.

 

[Priyanka]

Thank you Emma for the response