FDA clearance for a device that can't be used clinically (at present)

#1
My client has an innovative idea for an electro-mechanical software controlled device (a "system") that has available predicates for a future 510(k) submission.

A key component (mechanical in nature) possibly could be cleared in advance of the system. Its design is unique but the intended use/indication for use is substantially equivalent to existing devices. This clearance would be valuable to my client for fund raising purposes and regulatory risk minimization re the unique design of the key component.

However, if this component were cleared, it could not be used clinically because the system is not cleared and there is no interoperability available with existing cleared medical devices.

Has anyone seen where FDA will clear a device even tho it cannot be used clinically? I've not seen any guidance on this. I do know that we can ask FDA for an opinion via the Q-sub process.
 
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Watchcat

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#2
We regulatory professionals I try never to say never, only "it depends." In this case, however, I will just say no.

...the intended use/indication for use is substantially equivalent to existing devices.
...it could not be used clinically
These statements are contradictory. It cannot have an intended use substantially equivalent to existing devices, because, as cleared, and also as a component, it is not intended to be used clinically. The fact that the intention is to some day clear a system, of which it is only a component, that will have an intended use substantially equivalent to existing devices does not change this. As a component that cannot be used clinically on its own, it is not even a medical device.

To look at it from a different perspective, this is "the intention." The statistics on medical device startups say that it is unlikely to ever become a reality. From FDA's perspective, this would be a poor use of its resources.
 
#5
Hello, Watchcat and Ed,
Thank you for your comments. The following class II medical device codes cannot be used clinically by themselves yet FDA has devices in these codes: these devices must be used with other components which may or may not be medical devices: IXI, block, beam shaping, radiation therapy; JAD therapeutic x ray system (has systems cleared and collimator type (beam shaping block) components only); KQA, device, beam limiting, x-ray, therapeutic; IYI accelerator, linear, medical (includes systems and components); x-ray generators (IYH, IYD). Additionally FDA cleared K102915 treatment planning software in advance of clearing the system that the software would run on.
 

Watchcat

Trusted Information Resource
#6
The following class II medical device codes cannot be used clinically by themselves
"By themselves" isn't the issue. Your device cannot be used clinically with other devices, because there are no other devices that it can be used with clinically, except in your client's head.
 
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