Submit under a new product code in a 510k?

SSchoepel

Involved In Discussions
#1
Hello, we have a class II device that has two product codes under which companies have cleared their device. One is more software and one is more hardware, but neither exclude the other wholesale so there is a mix of devices (hardware only, hardware/software, software only) in one and mostly software in the other. The benefit of the "other" code is that it can be reviewed by a third-party reviewer. We'd prefer not to use both codes since they are under two different groups in the FDA so would then be reviewed by the third-party AND the FDA.

Is it possible/allowable to submit under a new product code with a new 510k submission? We would then change our listings once cleared under the new code. However, I'm not sure if that would fly with the FDA.

Does anyone have experience switching codes?
 
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shimonv

Trusted Information Resource
#2
It depends on how well the new product code describes your product and also what is the product code of your predicate. FDA may ask you to change the product code to something more suitable.
 

SSchoepel

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#3
It depends on how well the new product code describes your product and also what is the product code of your predicate. FDA may ask you to change the product code to something more suitable.
That's the problem, both could describe the product. Many new ones have used the "other" code because it's a 3rd party review and seems to be a little less scrutinized. I'm not sure if the FDA would push back on the re-categorization. (I also believe they have two codes that are too similarly used but have different requirements and should combine them.)

I hope others have experiences so I can see if this is a viable thing to do given that I am being asked about making that change.
 

mihzago

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#4
I don't understand why you wouldn't want to include both codes. It's very common to identify the primary and secondary (subsequent) product codes.
Why would your device be reviewed by the FDA and a third-party?

Your primary code should be the same (in most cases) as the main predicate you use to claim substantial equivalence.
 

SSchoepel

Involved In Discussions
#5
I don't understand why you wouldn't want to include both codes. It's very common to identify the primary and secondary (subsequent) product codes.
Why would your device be reviewed by the FDA and a third-party?

Your primary code should be the same (in most cases) as the main predicate you use to claim substantial equivalence.
The two codes are in two different areas so would get review by both teams at the FDA, which could lengthen the review process.

Historically the product was cleared under the more product code that doesn't allow 3rd party review and has a FDA review group that seems to hold the devices to a much stricter set of claims. The other product code wasn't supposed to have devices like ours but has expanded as companies have pulled apart their devices into "modules" and used the same code, reviews seem to move faster, and have fewer requirements for documentation submitted and proof based on a review of the two codes.
 

mihzago

Trusted Information Resource
#6
The submission would not be reviewed by both teams or assigned to two lead reviewers, unless you send two separate submission. FDA does not have that many resources. At most, a lead reviewer may ask for a consult from an SME in another branch, but that will not extend the time beyond FDA's review goal, i.e., 90 days.

3rd party review is a an option to you, but it's not a requirement or something automatically imposed on you. Just because a 3rd party review is available for a product code does not mean your submission will go to them. They charge a lot of money for it so the FDA cannot force you to do that either.
And even when a 3rd party performs the review, FDA still reviews parts of the submission and 3rd party's recommendation, and make final determination, so the 3rd party cannot be simply less strict.

It is possible that one branch may be more difficult than another, so if you have a predicate with the primary product code within the preferred branch, then submit under that classification/product code. The agency could still assign it to another branch depending on reviewer availability and expertise.
If reviewers have less to review because the device is simpler (e.g., software only vs. software/hardware) or if they have to review fewer modifications, then naturally the review will go smoother and possibly faster, but that's because the submission is simpler, not because somehow two branches are involved or two codes are applicable.

I don't know what your device is or what product codes in question, so maybe you are in a really weird situation, but still my advice is to select the product code based on your most appropriate predicate device.
 
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