510(K) Ownership and Protection from Use by Others

sherley13

Involved In Discussions
#1
We ourselves(our company) and the vendor have an establishment registration and listing. We would be listed as the relabeler, reprocessor, distributor etc for device importing in to United States and the vendor would be listed as the manufacturer.

I also understand the 510K ownership to work as follows:
? If we own the 510K the vendor is not allowed to use that 510k for other distributors.
? If the vendor owns the 510K, he can use the 510K with any number of distributors.
? If another distributor of the vendor owns the 510K, we cannot use it unless authorized.

With that said, how is this enforced? How is our 510K protected so other distributors do not use it? Are the 510K numbers actually checked to determine which parties are using it? Where is it checked? How often is it checked? Does misuse occur?

Please guide me on the above.
 
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MIREGMGR

#2
how is this enforced? How is our 510K protected so other distributors do not use it? Are the 510K numbers actually checked to determine which parties are using it? Where is it checked? How often is it checked? Does misuse occur?
To the best of my knowledge, FDA does not have an internal review/oversight process as to 510(k) ownership and therefore right-to-use...so they don't look for situations where enforcement is needed, even though they certainly have the legal authority to stop unauthorized use. FDA directly says in a guidance for which I can't find a link at present that they don't want to be involved in 510(k) ownership once approved, and do not want to be informed when a 510(k) is sold by one party to another.

You as the 510(k) owner can complain to FDA if you think a 510(k) is being referenced without your authorization. I don't know of any way for you to access the information you would need to verify such use, though. 510(k)s of course must be identified in the Listing database, but the public version of that database (i.e. for companies other that one's own) does not include the 510(k) information, and as far as I can tell neither does any other FDA externally accessible database.

All that you could do is research what 510(k)s exist that pertain to your 510(k)'s subject...as best you can tell from the limited subject-information provided...and try to verify your suspicions by inference.

You could call DSMICA and ask how to proceed.
 
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