Ownership of 510(k) to transfer or submit new one - Class 1 medical device

A

Achemd

Hi all,
I am looking for some ideas on how to handle this. We currently manufacture for a company a class 1 device. They hold the 510(k) under their name. What do we need for 510(k) approval under our name?
Must we submit all the documents as if it is a new filing?
Can we reference their 510(k) and submit no supporting documents except anme and co change and perhaps labeling?

:2cents: always welcome and thanks
Laurel
 

Al Rosen

Leader
Super Moderator
Re: Ownership of 510(k) to transfer or submit new one

Hi all,
I am looking for some ideas on how to handle this. We currently manufacture for a company a class 1 device. They hold the 510(k) under their name. What do we need for 510(k) approval under our name?
Must we submit all the documents as if it is a new filing?
Can we reference their 510(k) and submit no supporting documents except anme and co change and perhaps labeling?

:2cents: always welcome and thanks
Laurel
Look at Transfer of 510(k) Ownership
 
A

Achemd

Re: Ownership of 510(k) to transfer or submit new one

Thank you Al, that could save a lot of work if they buy into it!

:thanx:
 
A

Achemd

Re: Ownership of 510(k) to transfer or submit new one

Al, do you have a link where this is published on the FDA site? I have searched.
Thanks
 
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