Use repackers 510(k)?

[Fredde]

Urgent help needed.

We are manufacturing a class II device which is sold in bulk to a company who has made a 510(k) on the device.

We are now in the situation that we would like to also sell this device in the US under a different name and our own IFU (which basically is identical). Transfer of the 510(k) or Private labeling in cooperation with the original 510(k) holder is not an option.

The question is simple; Can we use the existing 510(k) from the other company and just list the "new" device, or not?

We ourselvesw are registered in US with several 510(k)s of our own, but would like not to have to do our own for this particular device since there is one already (but with a different name).

Searched the forum, and there are some similar questions, but no clear answer.

Thank you.

 

[Ronen E]

Re: Use repackers 510(k) ?

Urgent help needed.

We are manufacturing a class II device which is sold in bulk to a company who has made a 510(k) on the device.

We are now in the situation that we would like to also sell this device in the US under a different name and our own IFU (which basically is identical). Transfer of the 510(k) or Private labeling in cooperation with the original 510(k) holder is not an option.

The question is simple; Can we use the existing 510(k) from the other company and just list the "new" device, or not?

We ourselvesw are registered in US with several 510(k)s of our own, but would like not to have to do our own for this particular device since there is one already (but with a different name).

Searched the forum, and there are some similar questions, but no clear answer.

Thank you.

Hi,

In order to sell based on the existing 510k you must be able to prove that the device you sell is identical to the one described in that 510k submission, from any and all significant aspects. Can you do it? Do you have access to the full original submission?

Cheers,
Ronen.

 

[Fredde]

Re: Use repackers 510(k) ?

Thank you for your response.

Yes, we provided the documentation for the 510(k) submission to them.

 

[Ronen E]

Re: Use repackers 510(k) ?

you must be able to prove that the device you sell is identical to the one described in that 510k submission, from any and all significant aspects.

This includes packaging, sterilization (if applicable) and labelling. You noted that you sell them the product in bulk. Did you also provide them the 510k documentation concerning the aspects above?

 

[ascherp]

To my knowledge, you need a 510(k) owner's written permission to use his K-number for listing. For marketing purposes in the US, the device has become the 510(k) owner's device and sale of the device by any other company (even the actual manufacturer) needs to be authorized by the 510(k) owner.

I'm afraid the only advantage you can get from the fact that you have all the documentation and that the cleared device is identical to the one you would put on the market is that you have a perfect predicate for your own 510(k) submission.

 

[Fredde]

We helped them with their labeling and other aspects of the 510(k) although not submitted by us to the FDA.

As far as I can understand, the best option would be to try to get an agreement in place and transfer the 510(k) to us?
The 510(k) clearly identifies us as being the manufacturer of the device so there should not be any problems as far as FDA is concerned.

At least that would save us the time instead of a 510(k).
Anyone who has transfered a 510(k) and could supply any practical advise?

Thanks for great help!!

 

[ascherp]

I agree, transferring the 510(k) to you would be the best option.

Once you have your agreement in place with the 510(k) owner, you need to notify the FDA so that they can put you in their system as the new 510(k) owner. Then you can list.

The last time (18 months ago) we took care of a 510(k) transfer the new owner had to send a letter stating that he was the new owner of the 510(k) and some sort of evidence, such as a signed agreement. The transfer was then added by the FDA to the 510(k) records. (The 510(k) database will always show the original applicant's name, by the way.)

Since there has been a lot of reorganizing going on at the FDA, I suggest you call DICE to find out whether the procedure has changed and where to send your documentation.

 

[Ronen E]

Hi,

Ascherp, could you please refer to the regulation that requires what you've stated? There may be some "proprietary law" provision somewhere (not my expertise), but I'm not aware of a medical devices (FDA) per-se regulation that requires so.

Please also note that the OP didn't ask about 510k ownership transfer. I far as I could understand the current owner intends to continue marketing, so they probably won't be interested in giving up their 510k ownership. The question related to piggybacking onto the existing 510k. I do agree that a formal agreement is a very good solution, from all sorts of aspects, if they can pull it off (I would expect the owner to ask for some compensation, naturally).

As far as I know, the FDA doesn't orderly and fully monitor / track 510k ownerships. Perhaps they add it to the 510k records when such information becomes available to them, but I'm not aware of a comprehensive database for all 510k ownerships, nor of such a policy across the board. Maybe this is something in the making or a "local" initiative of some office. It is not unheard of that FDA has acted inconsistently on something until it became a problem and got formal attention, usually leading to an orderly review and issuance of a new guidance. If you know of a relevant guidance, I'd appreciate a pointer.

A 510(k) may be bought, sold, or transferred. FDA is not involved in transfers of ownership. The new owner should maintain information documenting the transfer of ownership of a 510(k), including any legal transactions that took place, in its 510(k) files.
The new owner should list the device according to 21 CFR part 807 and the previous owner should delete its device listing. Upon inspection of the firm or upon entry of glove shipments into the U.S., FDA may request a review of documentation of ownership. If the owner is not able to provide the information, FDA may request the owner to submit a 510(k). You may not distribute the gloves until FDA clears the new submission.
Note that neither a registration nor a listing proves 510(k) ownership. The new owner of the 510(k) should maintain files with documentation proving ownership of the 510(k).
To avoid problems when importing a device with a transferred 510(k) ownership, FDA recommends that a copy of the specific information relating to the ownership sale or transfer accompany all shipments to the United States. This could be a simple one-page document detailing the transfer transaction.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm150086.htm#5k

Cheers,
Ronen.

 

[ascherp]

Hi,
I checked the regulations and found that the issue of reporting transferred ownership of a 510(k) to the FDA is mainly a concern for foreign companies, since shipments of the new 510(k) owner may be held up at customs until the question of ownership is resolved. This is actually how I first became aware of the requirement. By reporting the transfer, the new owner does not need to accompany every single shipment with written proof of ownership.

In any case, the cleared device belongs to the 510(k) applicant. Anyone who wishes to market it in the United States under their own label needs the 510(k) owner's authorization in writing. Then they can list.

 

[Ronen E]

Thanks.

Anyone who wishes to market it in the United States under their own label needs the 510(k) owner's authorization in writing. Then they can list.

Sounds reasonable, but can you please point out the legal provision this statement is based on? And how this is enforced if the FDA doesn't track 510k ownership?