Class II to OTC conversion of a medical device



Our company wants to apply to US FDA for an OTC classification of our Class II medical device. I have the following questions:

1. Should we submit a 510(k) application? - our device already has a 510(k) certification, but as a Class II device.
2. What if there was no other device of the same type in the OTC classification? Can we still apply and request to be considered for an OTC classification, even if there is no predicate device with OTC classification ?
3. Is there any guidance documents available from FDA on this subject?



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Yes, you will have to submit a 510(k). This is not a change in classification (though FDA might create a new product code); rather, it's an extension of your indications for use.

There are a number of guidance documents for a submission of a 510(k), but I don't think there is one specific to going from Rx to OTC.
You should be able to find some info in one of these guidance docs.

I'm also providing a link to a usability guidance, because one of the main things you will have to provide is usability data that the lay users can properly use the device.
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