510(k) holder after bankruptcy

Chrisx

Involved In Discussions
#1
We distribute a device that is manufactured by a third party. The third party manufacturer holds the 510(k). They are in bankruptcy and are likely to go out of business. Does anyone know who becomes the holder of the 510(k) if the legal entity is dissolved? Is it determined in bankruptcy court?

Thanks,
ChrisX
 
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JeantheBigone

Quite Involved in Discussions
#2
Now THAT is an interesting question.

My gut feeling is that the 510(k) would be treated like any other IP such as a patent, but I suspect that the place to ask that question would be a forum frequented by lawyers. :)
 

pkost

Trusted Information Resource
#3
JeantheBigone's advise is spot on...speak to a lawyer

IANAL and these comments are given on my limited understand of corporate bankruptcy:

the law on this is horrendously complex and varies by country, as a general concept: corporate bankruptcy doesn't tend to go through court in the way individuals do, instead (if it is being closed down) an administrator (or trustees) is appointed who represents the creditors and shareholders. They are responsible for maximising the value returned (or minimising the lose) to these two groups by selling off the assets

The 510k is an asset because it is intellectual property (IP), it has value and can be transferred

If you are a simple distributor who has no contractual rights to the IP, you are perfectly within your rights to approach the administrators and offer to buy the 510k; remember that they have an obligation to minimise the lose to the company creditors so they may approach other parties who would be interested (i.e. your competitors).

If you have a more complex relationship and have some contractual rights over the 510k then I'm guessing you may be in a more difficult situation because you may be classed as a creditor....in this case, definitely speak to a lawyer

For reference this FDA guidance on transferring 510ks may be of interest (https://www.fda.gov/downloads/medic...onandguidance/guidancedocuments/ucm427385.pdf)
 
#4
My gut feeling would be to try to grab/extract/toxify the 510(k) if you can even hint at making a claim to being the Holder and then try exclude it from the bankruptcy proceedings as it would appear to be a business continuity risk for your company.

Think of the consequences.

What happens if it gets auctioned off and sold to your competitor?

Is it already listed as an asset in the proceedings? This is such a specialized area no one may know that much about it.

How far along are the proceedings? What kind of proceedings are they? Liquidation or just debt restructuring (company dies v. company survives)?

At least you have a license, whether or not it is in writing, otherwise you can't produce under that 510(k), right?

What happens to licenses under a bankruptcy? Any royalties owed to the company going bankrupt?

Some thorny questions here.

You should also be the only one producing under that 510(k), right?

Are you a creditor in the bankruptcy proceedings? Maybe you should be.

This is not legal advice, of course.

My advice is: get in touch with a lawyer.
 
Last edited:
A

Access2hc

#5
the 510k is owned by the person/company that FDA addresses to.

not sure why you would like to have the 510k because post-bankruptcy you may not be able to maintain the documentationt that supports that 510k, nor sure if there is product for you to distribute.

Cheers,
Ee Bin
Access2hc
 
#6
the 510k is owned by the person/company that FDA addresses to.
I must disagree with this statement. 510(k)s belong to the person/company that owns them, which is not tautological. 510(k)s, once issued, cannot be amended except for typographical errors. Yet a company may transfer their 510(k) to another company. In this case, the FDA will not amend the 510(k) and recommends that the new owner maintain some documentation to evidence the transfer in the case of a conflict over ownership in the future.

In an effort to eliminate this confusion, the FDA is working on a 510(k) database to keep track of ownership.

Here's draft guidance in support (pdf warning): https://www.fda.gov/downloads/medic...onandguidance/guidancedocuments/ucm427385.pdf

Here's a write up on 510(k) ownership disputes/issues (pdf warning):

https://pdfs.semanticscholar.org/a2e5/0e280fb2eb9900e83ee39fa96016ec4fc5d6.pdf
 
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