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How is the labeling of units cleared for both Rx and OTC uses handled?

Gaby

Registered
#1
Hello,

For a unit which 510(k) has both the "Prescription Use" and the "Over-The-Counter Use" checked on its 510(k) summary - how is the labeling supposed to be handled?
- one set of artwork for the OTC unit ... a version without Rx functions enabled or claimed?
- a separate set of artwork for Rx unit ... a version with Rx functions enabled and indicated on labeling?

I wouldn't think so.... but assuming one single set of artwork can be used, I guess the restrictions with respect to the Rx functions must be addressed via labeling?
How would sales be controlled then, being that there are certain functions cleared under prescription only? Could we sale it OTC even if marked Rx?

Thanks in advance.

Gaby
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
In my understanding Rx and OTC can't be cleared together. These are two different Intended Uses and thus two different devices that would require separate submissions. Then the labeling and distribution would be controlled according to the version.

The only way to clear both in a single device is to have one version - the lay use (OTC) one, with all the applicable limitations - also sold as an Rx one with the proper label statement (but no extra claims or features).
 

Gaby

Registered
#3
Thank you Ronen. The device I'm referring to was cleared under one single submission for both Prescription and OTC uses - see below how its 510(k) was issued. Said device is a combination of multiple cleared devices all in one, with combined intended uses. One of the multiple devices is a software analysis library which was cleared itself for both Prescription and OTC uses, and its 510(k) reads "This [device] is NOT intended for use in OTC use only devices". The software has a number of different capabilities, and one of them was cleared with a comment stating "(when prescribed or used under the care of a physician)".
I am really curious to know how the labeling of the combined device is supposed to be handled and if could be sold OTC (having the one software capability enabled).
Any further thoughts you may offer or other members of this forum would be highly appreciated.


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Ronen E

Problem Solver
Staff member
Super Moderator
#4
Sorry, I stand corrected. I was thinking in terms of simple devices and this case is apparently a complicated one, maybe even a special case (good reminder why the kind of help you can get in an open, voluntary forum is limited). Honestly, it doesn't make too much sense to me but I'm aware that I don't have the full history, technical/labeling details and rationales. Having only what you've written here, I'd say you need to go back to the FDA and ask them for guidance.
 
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