The problem is that OTC/Rx is not a device attribute listed as part of the classification page. For 510(k) devices, one must read the clearance letter. I’ve seen the same device by Product Code with different OTC/RX classifications in different clearance letters.
However, I believe that that a home use HIV test kit, Product Code MVZ, is an example of a Class III, PMA, OTC device.
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Dan O'Leary
Swanzey NH
United States
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Original Message:
Sent: 17-Jan-2017 10:07
From: Debbie Koeneman
Subject: Any Class 3 devices OTC?
Does anyone know of any examples of Class 3 PMA devices that are (or through later supplemental approval became) OTC devices? I only know of prescription ones and assume that all are, but I was challenged with this question. I have researched this but cannot find any examples of OTC.
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Debbie Koeneman
Consultant
Mesa AZ
United States
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