510(k) Ownership Change - Is it painful or is it a pretty easy process

A

aoldendo

#1
This is only tangentially related to 21 CFR Part 820, but I was wondering if anyone had first hand knowledge of changing ownership of a 510(k). Is it painful or is it a pretty easy process to carry out on the FDA's device and registration database??

Thanks..
 
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C

celia4237

#2
Re: 510(k) Ownership Change

Is there any answer? I am also interested in this topic
 
M

MIREGMGR

#3
Re: 510(k) Ownership Change

Go to the secure FDA DRML database, where you register establishments and list products. Your company's secure ID is required. Several options are available there for ownership changes, and it's possible to interact with a real person via phone or email, who can help with sorting out technical questions.
 
R

regfocus

#4
Re: 510(k) Ownership Change

Go to the secure FDA DRML database, where you register establishments and list products. Your company's secure ID is required. Several options are available there for ownership changes, and it's possible to interact with a real person via phone or email, who can help with sorting out technical questions.
This change is ONLY for the establishment ownership change.
 
M

MIREGMGR

#5
Re: 510(k) Ownership Change

This change is ONLY for the establishment ownership change.
I don't care to get into an argument, but it is possible, via interaction with the FDA through the DRML system, to transfer ownership of a 510(k). Call them up and ask them.
 
R

regfocus

#6
Re: 510(k) Ownership Change

I don't care to get into an argument, but it is possible, via interaction with the FDA through the DRML system, to transfer ownership of a 510(k). Call them up and ask them.
Thanks for the help :)
 
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