510(k) for a research purposes

shimonv

Trusted Information Resource
Hello Cove dwellers,
Recently one CEO approached me with a request to run a 510(k) application for research only purposes.
I am sure it has business advantages for a small start up seeking funding / exit, but from regulatory standpoint it makes little sense.

I found a 510(k) clearance with a similar concept - K152749, where the indication for use statement says the following:
510(k) for a research purposes


Have any of you accompanies such an application? it's not clear to me how and why should FDA deal with such an application.

Thanks for your input.
-Shimon
 

shimonv

Trusted Information Resource
That's the odd thing, they don't have an IRB. I guess they would like to show off to a potential investor and claim they have a 510(k) approval which is something. But it's not for commercial use...

I am trying to figure out what's the point in applying for such a clearance as apposed to classic 510(k) for commercial clinical device.
 

Hi_Its_Matt

Involved In Discussions
In my experience, smart people can sometimes ask for things using the wrong terminology. Is it possible that the CEO meant to ask you to run the type of premarket approval that is necessary to use an investigational device in a clinical trial, and they just accidentally called it a 510(k) instead of an IDE?

 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
A 510(k) by definition is not a new or unique device. That would be De Novo or IDE.
 

shimonv

Trusted Information Resource

Hi_Its_Matt,​

They want to get a 510(k) clearance for research a device. They want to sell their device to research facilities.
I think that's what K152749 is all about, but I have't seen something like that before.

Shimon
 

EmiliaBedelia

Quite Involved in Discussions
IMO, I don't think this company has a regulatory responsibility to get 510k clearance prior to selling their devices if they are for research use only. However, I imagine they think this would help those research facilities with THEIR regulatory submissions. Are they intending on working with pharmaceutical companies? If so, I see where the line of thinking is coming from... without knowing all the details, this sounds a lot like an ask I've gotten from pharma companies before.

From my experience with trying to sell devices for "research" or clinical trial use, a lot of companies like having a clearance to reference, even if it is not for their intended use. Saying in an IND or BLA, "We are using a device cleared for X use in K000000" answers a lot of questions that would otherwise have to be answered with, you know, actual testing or something. Using a cleared device reduces the risk for the pharma company - or at least, they think it does.

Personally I agree with you that this is a weird ask and maybe not 100% required, but I can see why someone got the idea and why it might be useful. If they pay you in legal tender, why not? :)
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Our device is 510(k) and used heavily in Pharma clinical trials.I dont think a trial manager would want a non reviewed device.
 

shimonv

Trusted Information Resource
Thanks EmiliaBedelia and Ed Panek,
Actually they don't intend on working with Pharma companies and initially it is intended to be sold for research institutes.
The thing is I don't know how much of a "discount" they get from FDA reviewers if it is indicated for research only. If no discount, then they should push for commercial release if they are ready for it. For sure, it would take more effort.


Shimon
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I guess a pre sub with FDA would help. I dont know how the FDA would review a not for commercial use device for clearance.
 
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