Transfer of a Medical Device 510k to a Foreign Company

[Bonebuilder]

Thank you very much. I also tracked down information on the FDA website that supports your position on transferring a 510k. It's a go! Thanks.

Hi Raspec

Can you direct me to the information on the FDA site, I find myself in a similar position in that we are a sub-contract manufacturer building devices for a Specification Developer that has gone into administration owing us a not inconsiderable amount of money who is offering the technical files, DHF etc to settle the debt. I need to confirm that if we accept the deal we can transfer the 510k into our own name.

regards
Bonebuilder

 

[MIREGMGR]

I need to confirm that if we accept the deal we can transfer the 510k into our own name.

There will be no change to the 510(k) database. FDA doesn't revise those records once entered.

External to FDA, a cleared 510(k) is a business asset, and as such it can be legally sold. This however is a legal, commercial transaction, not involving FDA. The buyer of the 510(k) retains the transaction documentation as evidence that they now have authority to cite that 510(k) as their clearance basis for marketing.

 

[Bonebuilder]

Thanks MIREGMGR,

What about the labelling of the device then, in your opinion given that the establishment address and the "manufactures" name will change is that going to require a special 510k?

 

[MIREGMGR]

What about the labelling of the device then, in your opinion given that the establishment address and the "manufactures" name will change is that going to require a special 510k?

No. Once you have commercially bought or otherwise obtained legal title to or legal permission to reference an existing 510(k), you may label your product under that 510(k) such that you are the Manufacturer or the Specification Provider, whichever applies. If a question arises from FDA at some point, you then provide them with your documentation.

 

[Bonebuilder]

No. Once you have commercially bought or otherwise obtained legal title to or legal permission to reference an existing 510(k), you may label your product under that 510(k) such that you are the Manufacturer or the Specification Provider, whichever applies. If a question arises from FDA at some point, you then provide them with your documentation.

Thanks for the clarification MIREGMGR,

Bear with me and please let me know when my questioning gets to the point by which you need a consultancy fee....! More than happy to buy you a pint already.

What about the annual listing? Do I simply list our device along with our establishment registration?

Thnaks

 

[MIREGMGR]

Bear with me and please let me know when my questioning gets to the point by which you need a consultancy fee.

Ummm, yes, could I please have $5000 from everyone for whom I've ever answered a question here? Small unmarked bills, please. No checks.

What about the annual listing? Do I simply list our device along with our establishment registration?

My understanding is, yes. This of course is one point where the FDA might do a database analysis and say internally, we didn't issue this 510(k) to the company that is listing with it, so we'll send an inquiry letter. And, you would respond with your transfer-of-ownership documentation.

 

[Bonebuilder]

Ummm, yes, could I please have $5000 from everyone for whom I've ever answered a question here? Small unmarked bills, please. No checks.



My understanding is, yes. This of course is one point where the FDA might do a database analysis and say internally, we didn't issue this 510(k) to the company that is listing with it, so we'll send an inquiry letter. And, you would respond with your transfer-of-ownership documentation.

You fully deserve your remuneration, mine will be in the mail shortly.

Thank you

 

[Ronen E]

Ummm, yes, could I please have $5000 from everyone for whom I've ever answered a question here? Small unmarked bills, please. No checks.

We're being paid with little "Thanks" clicks, which you can, in turn, use for purchasing some fairy dust at your local corner shop.

Seriously: A pint of beer in Australia is worth a lot of money! Though I heard that in the UK it's much less...

 

[Ronen E]

Thanks MIREGMGR,

What about the labelling of the device then, in your opinion given that the establishment address and the "manufactures" name will change is that going to require a special 510k?

A special 510(k) is required when the intended use is changed, or the device is technologically changed in a way that might raise new safety / effectiveness questions. IMO changing the manufacturer's details in the labelling is neither one.

Make sure, though, to keep the labels the same in terms of fonts, colours, sizes etc. - just replace the manufacturer's details.

Cheers,
Ronen.

 

[MIREGMGR]

Make sure, though, to keep the labels the same in terms of fonts, colours, sizes etc. - just replace the manufacturer's details.

My view, based on experience, would be that this isn't necessary as long as essential content and readability are maintained.

We do lots of private labeling, where a 510(k) device of our own is differently labeled for one of our many distributor customers under their name. Typically they want their own label design, with little visual and graphical resemblance to the label that was originally cleared, but of course the same essential content in each case. We've never had any negative feedback on that, over the past 35+ years.