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What if information in predicate 510k is obviously wrong?

Mark Meer

Trusted Information Resource
#1
I'm currently struggling with the following situation:

We've identified a great predicate that has the same technology and indications for use.

But, when I look up their 510(k), I notice that the listed product-code is inaccurate (there is a much more concise code to describe), and the listed review panel is obviously wrong (has nothing to do with the device).

So I'm struggling with the following decision: In our 510(k) should we:
a) Just list the same pro-code & panel, despite them being inaccurate/incorrect, or
b) Correct the error and use a more accurate pro-code, and the correct panel?

(b) is obviously preferable (as the resulting listing would more correctly describe the product), but I'm afraid that it would stall the approval process...

Any advice/input much appreciated...
 
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somashekar

Staff member
Super Moderator
#2
5. What do I do if the classification product code on my 510(k) substantially equivalent (SE) or PMA approval letter is incorrect?

Answer: Contact the appropriate review division within CDRH/CBER. The contact information will be at the bottom of the SE letter or approval letter. If the classification product code is incorrect, they will make the correction and send you a corrected clearance or approval letter.

7. What should I do if I notice an error in the product classification database?

Answer: Contact the product code coordinator at 301-796-5640 and the database will be corrected. The product classification database found at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/PCDSimpleSearch.cfm is updated weekly.
Above from HERE

I believe FDA has answers to most questions put in the FDA guidance documents...
 

Mark Meer

Trusted Information Resource
#3
Thanks somashekar, but I think what you've posted relates specifically to:
a) errors in your own 510k letter or listing; or
b) an error in the database

In the case I bring up the "error" is in an existing 510(k). We've obtained much of the 510(k) under FOI, and the inaccurate pro-code and erroneous panel were at the 510(k) submission level, and not in the subsequent acceptance letter or database entry. Apparently the 510(k) reviewer(s) didn't scrutinize these details in the application.

So, I don't want to challenge someone else's 510(k) details, even though any reasonable person would acknowledge the inaccuracy of the procode and incorrect panel.

Rather, I'm trying to survey people's opinions on how I should proceed in using this predicate 510(k) in my own submission. Is it better to:
a) Just list the same pro-code & panel, despite them being inaccurate/incorrect, or
b) Correct the error and use a more accurate pro-code, and the correct panel - Though this will surely attract FDA scrutiny when assessing substantial equivalence?
 
M

MIREGMGR

#5
I agree with Somashekar.

My expectation is that ultimately you will be asking FDA to fix the predicate 510(k), and they will do so.

Perhaps it won't be a simple process for any of the involved parties, but that's the only correct solution to the problem.
 
J

Julie O

#6
I recently came across an error in the PMA database. I contacted FDA. It took a bit of emailing back and forth with several different FDAers, in part because it spanned several different groups, but they corrected it within a week or two, as I recall.

You might want to start by emailing DICE and let them find the appropriate person to help you. Or you could start by contacting the appropriate branch, if you feel like you know which one that is.

Unless the information is factually consistent with the information in the clearance letter or 510(k) summary, I would not tell them that it is wrong, based on your opinion. They may think you are trying to argue for a code and panel that you think will serve you better. They get that a lot. I'd be inclined to simply ask why the one code was assigned instead of the other, and why the one panel instead of the other. If it is indeed the wrong code and panel, they will figure that out soon enough.

Would love to know how it goes.
 
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