How can I change the Owner / Operator for the Establishment in the FDA Device Registration and Listing Module?
Could you elaborate more on the "Change" ? Is it updating or transfer of ownership ... if there is a change in ownership (meaning company merged or acquired by another company), the procedure is different.
I believe it is just updating and if so, follow the steps as listed in -
http://www.fda.gov/MedicalDevices/D...evice/RegistrationandListing/ucm053185.htm#11
To update the owner/operator’s account information:
Log into FURLS using the owner/operator account id and password.
Click on "Edit Profile."
Select the radio button next to "Account." If you are both the owner/operator and official correspondent for the facility, then you will only see one "Account" when you click on "Edit Profile." If you have designated a person to be the official correspondent for the facility, then you will see "Account" and "Sub-Account" when you click on "Edit Profile."
Click on "Modify."
Make any necessary changes to the account and click "Submit". Any changes you make to the owner/operator account will be reflected in the Owner/Operator Information for the facility.
To update the official correspondent’s account information:
The owner/operator must log into FURLS using the owner/operator account id and password.
Click on "Edit Profile."
Select the radio button next to "Sub-Account" to modify the official correspondent’s information.
Click on "Modify."
Make any necessary changes to the account and click "Submit". The changes you make will automatically be reflected in the official correspondent’s information for the facility.
To create new subaccounts for official correspondents:
Log into FURLS using the owner/operator account id and password.
Click on "Create a Subaccount."
Enter the contact information of the official correspondent.
Click on "Continue."
Review the information and click on "Submit."
(If you change the official correspondent of facility and create a new subaccount for this official correspondent, then you will need to do the following steps to update the official correspondent for the facility)
Click on "Device Registration and Listing."
From the main menu, select "Change Official Correspondent for a Facility" and click "Continue."
Check the box next to the facility that you want to change the official correspondent for and click "Continue."
Select the box next to the new official correspondent and click on "Continue."
Review the change and click on "Submit."