A company wants to know what are the requirements/process to have a Class II disposable medical device get OTC 510(k) clearance? The device has has a cleared 510(K) but there is no predicate for OTC.
I
think if there is no OTC predicate for a device type currently being marketed Rx, it can't get to OTC via Traditional 510(k).
Have you talked to FDA yet? Maybe it's possible for them to allow that via re-classification.
If the device will be considered low or medium-low risk by FDA, you could consider the relatively new De Novo procedure, in which you file for automatic Class III classification, then re-file for De Novo (predicate-less) re-classification to Class I or II. In the De Novo procedure, I don't know of any restriction on ending up at OTC if safety and effectiveness have been adequately shown.
Clinicals have been done to show ease of use etc.
Done with the typical OTC users? Did the clinicals only focus on use as intended, or did they cover the full range of potential uses and misuses to show safety and effectiveness?
Also - what parameters need to be proven from a user's perspective? Usability? comprehension of IFU, ease of use? anything else? Are these type of requirements defined somewhere?
All of those. Ease of use isn't really the point, though, except insofar as it pertains to safety and effectiveness. The FDA will focus on whether the device is assuredly safe and effective when used without professional guidance, and when it could be used in combination with other treatment approaches, or mis-used.