FDA's DRLM (Device Registration & Listing Module) Listing Number Question

[piccoto]

Hi all!
We manufacture a medical device that comes in different colors and cable lengths, hence we have several different catalog numbers all covered under one 510K and one Listing Number.
My question is: In the FDA's DRLM (Device Registration & Listing Module) - are we requires to specify all catalog numbers that are under this Listing Number/510K? We entered our "Propriety Name" of the device, but never entered any "Device Identifiers". Are we obliged to do it?

Thanks for any inputs on this issue! So confused!

 

[Mark Meer]

Just based off memory, I don't think it's even possible to do this in the DRLM. If I recall correctly, you can only have one listing for a given 510(k).

The GUDID database, on the other hand, is where you'd have multiple entries for the different configurations.

EDIT: this was a confusion that I'd also expressed in this thread. There was no resolution. I ended up just entering a "generic" identifier in the DRLM listing, and then specifying the different configurations (with their unique DIs) using the GUDID.

 

[piccoto]

Thanks Mark! I though "Device Identifiers" was in the meaning of "Catalog numbers". We also have many DIs on one 510K/Listing Number... I would simply leave this field empty.

I still don't understand whether I have to register all my catalog number with the FDA. In Canada, for instance, all our catalog numbers are registered. Same goes for Europe - all numbers appear in the DoC. Is it possible that in the US you don't need to specify which catalog numbers are covered in your 510K ???

 

[LFZR88]

Hello,
There is some pretty good advice from the FDA here Frequently Asked Questions about the New Device Registration and Listing Requirements Under 'Proprietary (Brand) Names' heading. My understanding of this is that they are asking for a brand name and not a product code, so you do not need to add all sizes etc just the main name of the branded product. However I do add a product code when there is a specific difference ie a single device or a pack of 2, this is personal preference, it makes it easier for anyone else in the company to see exactly what is listed/registered with the FDA.
you could also have a search through some companies that have similar products and see what they have done (if they are not hidden from view)

 

[piccoto]

Thank you LFZR88, this is very helpful information!
I actually looked at other companies' submissions and didn't see the catalog numbers, but these 510K were all very old.

Would you please explain how do you add a product code? Is it in the DRLM?

Thanks!

 

[LFZR88]

Hello Piccoto,
Did you search for devices under 'pro codes'? if you go to the establishment search page Establishment Registration & Device Listing and put in the 3 letter FDA pro code (for your device) that will give you all the devices under that pro code for comparision, if you have the company name it's easier, anyway you may not need to but it is a useful search.
your question re adding a product code, are you asking about adding your product code to an existing proprietary name listing or something else?

 

[piccoto]

Hi LFZR88!
I really made a mess with the terminology! I meant "Product Code" in the meaning of "Catalog Number"...
Here is the situation. We have:
1 510K number,
1 listing number,
1 FDA Product code,
for 20 different catalog numbers which appear on our website and catalog. The question is: how can someone be sure that all 20 different catalog numbers are covered under our 510K/listing number? they do not appear in the 510K documentation. Are we suppose to make the link between the catalog numbers and the 510K/listing number?

I have been trying to figure this out in last few days and from all the information I have, I believe the answer is NO. No connection between 510K/listing number and catalog numbers. For instance, I can add catalog numbers to a certain 510K number/listing number (assuming minor change were made and new submission isn't required) and FDA does not need to be notified (as opposed to Canada and Europe).

If someone thinks or knows something else - kindly let me know
Thanks!

 

[jeinho1]

How do I obtain a LST # (device listing number)

Hello,

I recently started importing FDA approved medical devices. Currently, not registered with the FDA as I was just a domestic distributor. I know now I need to register as I'm importing these devices. The problem I'm running into is providing the LST # when asked trying to get the shipment released from customs/FDA. If the exporter is not registered there is nothing I can do as its proprietary information.
My question - Once registered with the FDA how do I go about registered devices that I'm importing? I would like to register each device I'm importing so I have the information if asked. Is there a fee for each device I register? How long does this process take? Thanks in advance!

 

[JeantheBigone]

Registration and Listing shouldn't take very long.

How to Register and List

Step one is to get a DFUF account so you can pay the fee. Don't even look at the DRLM until you've paid it, because without both the Payment Identification Number and the payment Confirmation Number the system won't save anything you've entered. So you can spend an hour for nothing.

The fee goes by establishment address, so once you are registered, you can list as many devices as you want.

I'm not sure what you mean by LST#. If the foreign manufacturer or exporter isn't registered and hasn't listed, there is a much bigger problem. US Customs will spot check incoming goods and turn over inspection to an FDA Inspector. If that inspector cannot verify that the goods are coming from an establishment that is registered and has listed the device and is intended for an establishment that is registered and has listed the device (unless it's a final customer) then they will quarantine it and someone will get a detained entry notice.

It usually takes a day or two for payment to clear and once you have the PIN-PCN you can register and list.

 

[jeinho1]

Thank You so much for your reply, JeantheBigone!