Predicate device recalled - Still a valid predicate device?

tehuff

Involved In Discussions
#1
Hi Covers,
My company has selected a predicate device that was just recently recalled (Class 2 recall per FDA) because it doesn't meet its specifications. Unfortunately, much testing has already been done. Can this device still be used as a viable predicate for a 510(k) submission? There is a performance standard for these devices so the plan is to compare the new device to the performance standard and cite the specifications from the 510(k) of the predicate device to demonstrate substantial equivalence. Is this reasonable?
 
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MIREGMGR

#2
I don't think there is a definitive answer for you, or path forward. You may need to request a meeting with FDA to determine how to proceed. They may request a Pre-Sub to define the questions that the meeting is to address.
 

somashekar

Staff member
Super Moderator
#3
Hi Covers,
My company has selected a predicate device that was just recently recalled (Class 2 recall per FDA) because it doesn't meet its specifications. Unfortunately, much testing has already been done. Can this device still be used as a viable predicate for a 510(k) submission? There is a performance standard for these devices so the plan is to compare the new device to the performance standard and cite the specifications from the 510(k) of the predicate device to demonstrate substantial equivalence. Is this reasonable?
For me, the recall is to a specific lot / batch of that device.
This recall does not invalidate the device you predicate.
Its more an issue to that manufacturer than to his device which has a 510k.
A final word with FDA is the way to go, now that you know of the recall.
 
#4
As long as the predicate hasn't been removed from the market by the Commissioner or hasn't been determined to be misbranded or adulterated by a decision of the courts, then the predicate will still be valid.
 
M

MIREGMGR

#5
My take would be that the question is not theoretical...it instead goes to what actually happens when the reviewer group becomes aware of the recall and begins asking questions about the testing process, the device substantial-equivalence comparison, and to what extent the performance discrepancy of the predicate device is potentially applicable to the subject device.

If I were the submitter, I very much would want to discuss those matters with FDA as early as possible, rather than having them be the initiator of the interactions after considerable submission effort had been made.
 

mihzago

Trusted Information Resource
#6
Devices are frequently recalled because they fail to meet the specified performance or safety.
In the 510(k) you compare your new device to a predicate that was submitted to the FDA, not the one that's currently on the market. So unless, as J0anne said, the device hasn't been removed you can still use it; but, be prepared to address questions related to the recall. Better yet, include the cause of the recall of the predicate device in your risk assessment and show how you've addressed it.
 
J

Julie O

#7
If you really mean "recalled," rather than "withdrawn," then, yes, it is still a valid predicate. You will want to pay attention to the reason for the recall, and consider whether your device might have the same problem, or whether it was just due to a goof by the manufacturer of the predicate. For example, the fact that they put the wrong label on a lot of their predicate, doesn't mean anything to you, except as a reminder for you (and all of us), that it's important to assure that you are putting the right labels on your product.
 
#8
This is not a comment on the validity of the predicate - several comments above have covered that.
If there has been any changes as to how the FDA views the predicate or the specific class of device in light of the recall, in terms of the classification of the device itself or the software contained in it, that will affect the new submission.
 
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