Hello,
I’m looking to submit my Rx device for OTC clearance via the 510(k) pathway, using my own previously cleared device as the predicate. This would make it the first device of its kind on the market to do so.
I understand that this roadmap has been used multiple times before, but I’m concerned it may not be applicable in my case since the device is currently defined as prescription under 21 CFR.
Is this considered a hard stop, or can the FDA grant an exemption to pursue an OTC indication via the 510(k) pathway—particularly if the predicate device is already designed for lay users and has a strong safety profile?
Has anyone had experience with a similar situation?
Thank you, as always, for your support!
I’m looking to submit my Rx device for OTC clearance via the 510(k) pathway, using my own previously cleared device as the predicate. This would make it the first device of its kind on the market to do so.
I understand that this roadmap has been used multiple times before, but I’m concerned it may not be applicable in my case since the device is currently defined as prescription under 21 CFR.
Is this considered a hard stop, or can the FDA grant an exemption to pursue an OTC indication via the 510(k) pathway—particularly if the predicate device is already designed for lay users and has a strong safety profile?
Has anyone had experience with a similar situation?
Thank you, as always, for your support!
