Review time should not be impacted. Your Usability studies would be different as would your labeling. It would also depend on if the same type of device has ever been cleared for OTC use for the same indications; if the indications are appropriate for OTC use; if the safety and efficacy is appropriate for OTC use. For example, a device intended for use for Sleep Apnea would likely be problematic for an OTC clearance because a physician must diagnose sleep apnea - it cannot be self-diagnosed.Another example: TENS devices for OTC use typically have limited output so the output of energy is much lower for OTC than Rx devices. FDA did have draft guidance for TENS devices for RX and OTC, but they were withdrawn. Only 3 guidance documents include "Over the counter" so probably not too much help there. You could search the 510(k) database under your product code and see what is different in the 510(k) summaries of those that are Rx versus OTC.
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Diane Rutherford
Corinth TX
United States
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Original Message:
Sent: 23-Mar-2018 08:56
From: Mary Ann Greenawalt
Subject: Rx vs OTC for devices
Hi all. Can anyone explain to me and/or cite a reference on the clear distinctions for go-to-market as Rx devices vs OTC device. I realize labeling and review time are distinctions. Is there anything we know for certain?
Mary Ann
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Mary Ann Greenawalt
Regulatory Affairs
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