FDA Listing a Class I that goes into a Class II

ScottK

Not out of the crisis
Leader
Super Moderator
#1
we make strictly Class I, 510(k) exempt devices all under one product code and one listing. We were inspected as such a few months ago and the FDA inspector saw no issues.

We have a customer who puts our part into a device that then becomes a Class II device with a 510(k). They have asked that we put that into our listings using their 510(K) number - which will now add a Class II listing to our profile.

Since our product is Class I (and fairly old - pre ISO 13485 registration for us) we don't have the design data to back it up as a Class II would require. Not sure if it's pre-amendment.

If we comply with the customer's request, what are the ramifications to us suddenly having a Class II device in our listings?

Adding the listing is easy. But I'm wary of what it might do from a regulatory standpoint - will it turn us into a Class II manufacturer with increased inspection frequency and increased scrutiny of our D&D processes?

Why is this... it appears that this customer wrote their 510(k) specifically calling out our device by name, where our other cusomters just use a generic name in their submissions.
 
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MIREGMGR

#2
In theory, you don't have a choice as to how to List your product. It fits into one Class, and that's the only way to List it. So if you have it Listed as a Class I device, and that's how you market it, how would you List it a second time as a Class II device?

You don't market your product as a Class II device (or kit, or whatever the regulatory nature of their product)...your customer does. And if their kit is Class II by means of including another product that is Class II, you have nothing to do with that action.

And yes, if you List a Class II device, you are now visible to FDA as having a Class II product.

They have asked that we put that into our listings using their 510(K) number
I'm not sure that I understand you here. Your existing Listing presumably is as the Responsible Manufacturer. Are they asking that you create a second Listing as a Contract Manufacturer, linked to their own Listing as Specification Provider, for a second version of your product as they market it?

(There are several scenarios under the existing FDA classification system in which an accessory product, marketed by a company other than the makers of the products with which the accessory is to be used, needs to be Listed under multiple Product Codes to encompass all of the target products. This problem exists due to legacy system-design errors at FDA...to my knowledge, all of the applicable instances apply only to Class I target products. And, there is at least one situation where a product can be Listed under either a Class I or a Class II Product Code...again due to a legacy problem at FDA that was never fixed. But in general, products should fit into just one Product Code and one Class.)
 

ScottK

Not out of the crisis
Leader
Super Moderator
#3
In theory, you don't have a choice as to how to List your product. It fits into one Class, and that's the only way to List it. So if you have it Listed as a Class I device, and that's how you market it, how would you List it a second time as a Class II device?

You don't market your product as a Class II device (or kit, or whatever the regulatory nature of their product)...your customer does. And if their kit is Class II by means of including another product that is Class II, you have nothing to do with that action.

And yes, if you List a Class II device, you are now visible to FDA as having a Class II product.



I'm not sure that I understand you here. Your existing Listing presumably is as the Responsible Manufacturer. Are they asking that you create a second Listing as a Contract Manufacturer, linked to their own Listing as Specification Provider, for a second version of your product as they market it?

(There are several scenarios under the existing FDA classification system in which an accessory product, marketed by a company other than the makers of the products with which the accessory is to be used, needs to be Listed under multiple Product Codes to encompass all of the target products. This problem exists due to legacy system-design errors at FDA...to my knowledge, all of the applicable instances apply only to Class I target products. And, there is at least one situation where a product can be Listed under either a Class I or a Class II Product Code...again due to a legacy problem at FDA that was never fixed. But in general, products should fit into just one Product Code and one Class.)
I'm trying to really understand what they are asking for, but I ran through the "create listing" process using their 501(k) number without pulling the final trigger and it looks like it would add their product to our listing list.
So it's essentially creating a "new" product - one that we only make a compornent for.
 

ScottK

Not out of the crisis
Leader
Super Moderator
#4
Apparently they are having trouble getting the component we make back into the country aftger prior export because there is a listing mismatch now.
 

Ronen E

Problem Solver
Moderator
#5
Hi,

To me it all sounds a little strange. I'm not aware of a requirement to list each and every component of a class II medical device, even if such component is (under another scenario / intended use) is considered a medical device in its own right.

As MIREGMGR suggested, if the situation is that you actually manufacture a finished device branded for them, or they just label it, and due to a different intended use or a classification system legacy fault it is classified by them as class II, that's a different story. You are then considered a Contract Manufacturer and required to list. Yes, you'd then be treated as a class II manufacturer, as unfortunate as that may be. In such a case the two versions should be looked at as two completely separate devices even though they are physically identical (minus the labeling), IMO.

Regarding post-export entry, it's unclear as what exactly the object is being imported. A component? A finished device? Further processed? Used? If you could elaborate a bit we might be able to be more effective.

Cheers,
Ronen.
 
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