How to change the FDA Device Registration and Listing Module - Owner/Operator

B

Bunny

#1
How can I change the Owner / Operator for the Establishment in the FDA Device Registration and Listing Module?
 
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Doug Tropf

Quite Involved in Discussions
#2
Re: How to change the FDA Listing - Owner/Operator

Information on the owner / operator is updated in the Account Management module of FURLS, accessed from the menu on the left side of the screen after logging in.
 

Ajit Basrur

Staff member
Admin
#3
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."
 
B

Bunny

#4
Something is wrong because I do not have the "Edit Profile" option. All I have is Change Password, System Access and Secret Question/Answer. By the way, I AM the Official Correspondent and would except to have all choices available to me. Is their a glitch on the website? I tried using IE and Mozilla.
 
M

MIREGMGR

#5
That means that you are logging into a subaccount.

You must log into the owner/operator (primary) account to have full control.

I verified this by logging into our account as the owner/operator, then logging out and logging in again using my own Official Correspondent subaccount. It's exactly as you describe.
 
M

MPiska

#6
In reality what are the different levels of responsibility of the owner/operator and official correspondent for a business?

I do all of the FDA listings work, but am in no way the owner/operator - should I be setting up a master account for our CEO and setting myself a subaccount?
 
M

MIREGMGR

#7
The website is set up with subaccount capability to allow more complicated working structures. There's no requirement that subaccounts be used, and no significance to who does the work. The presumption is that the Registered Establishment has authorized whoever accesses the website on their behalf.
 
M

MPiska

#8
Thanks for that - Just wanted to confirm it before I update the account as I'll now be listed as the Owner/Operator :mg:
 
M

MIREGMGR

#9
Thanks for that - Just wanted to confirm it before I update the account as I'll now be listed as the Owner/Operator :mg:
The listed Owner should be the actual owner, or at least the party that is identified for legal purposes as the owner.

It's fine for you to enter information into the website, even though you aren't the owner yourself, because the presumption is that you're authorized to do so by the owner. It would not be fine for you to be listed as the Owner if in fact the owner is some other party.
 
L

Lynn.Fu

#10
log into the FURL system, using the main Account, than you can edit the information you want to change or modify.
 
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