Sale of Rx Only Medical Device to Physician Online

[macchiato]

Hi All,

We have an Rx only device with class II 510k for home & hospital use. Up till now, we've been selling to large hospital systems but we have repeated requests from physicians to just buy a single device to use in their own practice with their patients. We'd like to make this easy for them to do online - just buying through the website - but make clear its Rx only and must only be purchased by a physician.

Does anyone know of:

A) whether this is legal under applicable legislation?
B) any applicable guidance in this area?

I've done a lot of searching but I can't seem to find much in the way of guidance on the topic.

TIA.

 

[Ronen E]

Hi,

As much as I understand, as a minimum you'll need the following to make the sale legal in the USA:

1. Your outlet (the site you'll process the transaction in and dispatch from) must be licensed by the Board of Pharmacy of the US State it's located in.
2. You'll need a signed prescription/order from a licensed (verify!) physician, for each device being dispatched.

FWIW, there's a seemingly current article here. It talks of prescription drugs but I have reasons to believe it's essentially the same for prescription devices - if not, I believe that the Board you approach will be able to tell you. I can't, though, vouch for the reliability of that article or website. The best, of course, would be to ask the FDA.

HTH
Ronen.