Possible to Submit a 510(k) if you have never, do not and cannot produce the device for which you're submitting the application?

[supadrai]

Happy 2021 everyone. I'm conducting due diligence on a medical glove transaction and have determined that the purported manufacturer actually doesn't have a facility capable of manufacturing the product. They have provided evidence of a 510(k) submission that was acknowledged by the FDA and expect it to be approved soon.

 

[monoj mon]

It doesn't matter if the manufacturer physically manufactures the device at their facility or not as long as the manufacturer follows 21CFR 820 while sub-contracting it to others. Since the manufacture doesn't manufacture it at their facility, they will need to identify the 'sub-contractor' facility while registering-listing their product.

Edit: I assume they must have already mentioned their 'sub-contractors' in the 510(k) submission.

 

[supadrai]

Thank you very much. I don't have access to their submission but the gloves they've sent to Satra, the government labs (Thailand), TUV, BSI, and local private labs were certainly not their own products and of course all those entities act upon the representations of the submitter.

 

[Watchcat]

I take it that, when you say "actually doesn't have a facility" you don't just mean they themselves do not own one, but they have not established a contractual relationship with the owner of another facility that could manufacture it?

One can pretty much always submit a 510(k). It will not always be accepted for review and it will not always be cleared.

What is it you want to know? Whether it is legal to submit one? Whether the FDA will accept it? Clear it? What value it has without a manufacturing facility available to make the cleared device? Whether they are likely to be misrepresenting when they claim they have submitted one?

If the latter, they should have an acknowledgement of receipt from FDA.

 

[Ed Panek]

FDA will approve a device even if a contract manufacturer is exclusively making it. I am assuming the submitter has design control over the product.