Share 510(k)s with our owner/operator??

M

mknight

#1
Hi All,

I am officially stuck and would like to borrow some of the wisdom found here on the cove. So here’s the question I work for a small medical device manufacturer that has a larger parent company that is also a medical device manufacturer. Our parent company is listed as our owner/operator with the FDA. The question has been asked if we can share 510(k)s with our parent company since it is our owner/operator. Has anyone heard about this or had experience with this type of situation?

Thanks in advance for your help!
:thanx:
 
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M

MIREGMGR

#2
Is the company you work directly for (the division of the larger company) registered as an Establishment under its own name?

What registered-Establishment company name was the 510(k) in question issued to?

A 510(k) is issued to just one registered-Establishment company. It's valid only for products Manufactured by that company, or contract-manufactured by someone else according to specs issued by that company as a Specification Developer. It's valid for products that that company markets under its name, or that it sells to Distributors, Re-Labelers, and/or Re-Packers.

Is the scenario that you envision, if the 510(k) was issued to the division as a separate registered Establishment, the products in question could be sold by the parent company as a Distributor or Re-Labeler.

Other than the above, I don't know of any legal basis for "sharing" a 510(k). You could always submit a question to DSMICA, though.
 
M

MIREGMGR

#4
Maybe I mis-interpreted the original post. I thought the question had to do with both companies (parent and child) making/marketing the same product, and in both cases basing their marketing regulatory clearance on the same 510(k)...in one case, as if it had been issued to them, even though in fact it was issued to the other company.
 
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