Is it required to put"Rx only" on the home page of an app?

#1
Hi everyone,
We have a medical device wirelessly controlled by a smartphone app. Our product is for Prescription use. So we have to put Rx only on the IFU and the label of the product.
But what about the app? Is it required to put Rx only on the home page of the app, in legal information.(The app is like a remote control for our product).
I have not seen anything about it in FDA guidance.
Thank you for your Help
 
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yodon

Staff member
Super Moderator
#2
The app is (I presume) nothing (esp. no risk) without the device so if someone were to download it, it would be of no use if they didn't have the device - so I would think Rx only would NOT be needed in the app. (That's my best guess - always best to check with a regulatory expert.) You might even want to pose the question directly to FDA.
 

yodon

Staff member
Super Moderator
#4
Might not be a bad idea to add something in the description in the app store about it only being used with a by-Rx-only device.
 
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