Must electrodes for Rx/prescription stimulators be Rx only?

N

noedum

#1
Hello

For USA market , we have 2 products which are electrical stimulators for nerve and muscle : one with IPF classification under prescription and one NGX for OTC use (510k in process). Both of the stimulators need the same electrodes (GXY classification) as accessories in order to perform. We purchased those electrodes from original supplier and repackage them under our brand name.
Our supplier historically got a 510k for the electrodes for prescription and recently issued a new 510 k for the same electrodes for OTC use only (not both OTC and prescription). The problem is that they will discontinue the old packaging for prescription (with Rx only statement) and only sold electrodes for OTC use.
But we still continue to market Rx stimulator. Then my questions.
Must electrodes for Rx/prescription stimulators be Rx only too ?
Can we market OTC electrodes to be used with Rx/prescription stimulators?
Should we label our electrodes for both prescription and OTC use based on the two 510 k from our original supplier, one for OTC one for prescription even if the original supplier electrodes are labelled only for OTC currently?
Thank you in advance,
Best regards,
 
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M

MIREGMGR

#3
We purchased those electrodes from original supplier and repackage them under our brand name.
Presumably you are re-labeling (in the regulatory sense) to implement the branding change.

Must electrodes for Rx/prescription stimulators be Rx only too ? Can we market OTC electrodes to be used with Rx/prescription stimulators?
Legally, an OTC device is required to come with IFU that is sufficient for the device to be used safely and effectively by a lay user. An Rx Only device is exempted from that requirement. That, in essence, is the substance of OTC vs. Rx Only.

So, a device that was cleared for marketing as OTC can be sold with Rx Only labeling. The only special requirement would be that the IFU and other product labeling information provided with the Rx Only version not contain conflicting information, i.e. pertaining to lay use, that might create confusion as to OTC vs. Rx Only status.

Should we label our electrodes for both prescription and OTC use
If what you mean is: put both OTC and Rx Only indications in the labeling for the same device, then no. No individual device may be labeled to indicated both OTC and Rx Only.
 
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