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Creating a Subaccount is optional. If additional personnel are desired to help manage registrations or other submissions, an Account holder may create Subaccounts for them as necessary. Subaccounts differ from Accounts in the amount of information available to each type of account. An Account holder acts as the administrator for a group of Subaccounts for your company. The Account holder can create Subaccounts, update account information for any of his accounts, deactivate accounts that are no longer required, and reactivate accounts as needed.
Subaccount holders are fully able to make submissions to FDA but are only allowed to change their secret question and answer and account password in Account Management. Subaccounts can also be promoted to Accounts, if needed. See Promote a Subaccount to an Account.
On the FDA Industry Systems home page, choose "Create a Subaccount" from the Account Management Menu.
NOTE: The use of names, companies, cities, and countries are used fictitiously for the purpose of illustrating examples of how to complete the screens. Any resemblance to actual persons, living or dead, business establishments, events, or locales is entirely coincidental
Enter the name, address(es), and telephone information for the person in charge of the Subaccount that you want to create (see Figure 1).
To create the Subaccount do the following:
Fields Included in this Section
All fields marked with an asterisk ( * ) are required.
If you are providing a preferred mailing address, the fields marked with ** are required.
| *First Name | The first name of the person who will manage this account. |
| Middle Initial | The first initial of the middle name (if applicable) of the person who will manage this account. |
| *Last Name / Surname | The last name of the person who will manage this account. |
| *Title | The professional title of the person who will manage this account; for example, President, CEO, or Plant Manager. |
| *Phone Number: Country Code | For foreign addresses, the three-digit country code of the telephone number of the account holder. |
| *Phone Number: Area/City Code | The three-digit area code (for domestic addresses) or city code (for foreign addresses) of the telephone number of the account holder. |
| *Phone Number: Phone Number | The telephone number for the account holder. |
| Phone Number: Extension | The telephone extension, if any, dialed after the telephone number, for the account holder. |
| FAX Number: Country Code | For foreign addresses, the three-digit country code of the telephone number of the FAX machine of the account holder. |
| FAX Number: Area/City Code | The three-digit area code (for domestic addresses) or city code (for foreign addresses) of the telephone number of the FAX machine of the account holder. |
| FAX Number: FAX Number | The telephone number of the FAX machine of the account holder. |
| E-mail Address | The account holder's internet electronic mail address. |
| Confirm E-mail | The internet electronic mail address must be entered a second time for verification. |
| *Country | The country in which the account holder is located. |
| *Address Line 1 | The address of the physical location where the account holder is located. This may be different from the mailing address. |
| Address Line 2 | Continuation of the address of the physical location where the account holder is located. This may be different from the mailing address. |
| *City | The city in which the account holder is located. |
| State | For domestic addresses the state in which the account holder is located. A state or a Province / Territory is required. |
| Province / Territory | For foreign addresses, the province, or territory in which the account holder is located. Select the link to choose a Province or Territory from a list for the Country selected. A state or a Province / Territory is required. |
| *Zip Code (Postal Code) | The Zip Code (domestic) or Postal Code (foreign) in which the account holder is located. |
| **Country | The country in which the account holder receives mail. |
| **Address / P.O. Box Line 1 | The address at which the account holder receives mail. |
| Address Line 2 | Continuation of the address at which the account holder receives mail. |
| **City | The city in which the account holder receives mail. |
| State | For domestic addresses, the state in which the account holder receives mail. A state or a Province / Territory is required. |
| Province / Territory | For foreign addresses, the province, or territory in which the account holder receives mail. Select the link to choose a Province or Territory from a list for the Country selected. A state or a Province / Territory is required. |
| **Zip Code (Postal Code) | The Zip Code (domestic) or Postal Code (foreign) in which the account holder receives mail. |
Figure 1:
Review the information that you have entered for this Subaccount (see Figure 2).
If you are satisfied that the information is correct, select Submit. If you need to make further changes, select Modify to return to the Create a Subaccount screen and make further edits.
Note: Warning: This address could not be validated, means that the system was unable to verify the address(es) you entered. You are advised to check the addresses. If they are correct, disregard the notice and submit the application. The application will be processed normally.
Figure 2:
The status of your request to create a Subaccount is displayed (see Figure 3). The system will generate the following message: The Subaccount was successfully created. The account ID is...
If an e-mail address was provided, the account ID and password will be sent to the e-mail address for the account holder. If no e-mail address was provided, the account ID and password will be sent by U.S. Postal Mail. Click the continue button to return to the FDA Industry Systems home page.
On the FDA Industry Systems home page, choose "Deactivate a Subaccount" from the Account Management Menu.
NOTE: The use of names, companies, cities, and countries are used fictitiously for the purpose of illustrating examples of how to complete the screens. Any resemblance to actual persons, living or dead, business establishments, events, or locales is entirely coincidental.
Change the status of a Subaccount from Active to Inactive. Accounts are deactivated for one of the following reasons:
To deactivate an account do the following:
Fields Included in this Section
All fields marked with an asterisk ( * ) are required.
| *¢Subaccount| xxxxxxxx | A system-generated identification code that enables you to login to FIS. |
| *Reason for account deactivation | The reason that the account will no longer be active. |
Figure 7:
Confirm deletion of the selected Subaccounts (see Figure 8).
To confirm deletion, do the following:
Figure 8:
The status of your request to deactivate one or more Subaccounts is displayed (Figure 9). When the process is complete, the system will display the following message: The subaccount was successfully deactivated.
The account can be reactivated using the Reactivate a Subaccount process. Click the continue button to return to the FDA Industry Systems home page.
Figure 9:
On the FDA Industry Systems home page, choose "Reactivate a Subaccount" from the Account Management Menu.
NOTE: The use of names, companies, cities, and countries are used fictitiously for the purpose of illustrating examples of how to complete the screens. Any resemblance to actual persons, living or dead, business establishments, events, or locales is entirely coincidental
Select the deactivated account(s) that you want to reactivate.
To select one or more accounts, do the following:
Note: Account holders cannot reactivate Subaccounts that were deactivated by FDA. If you want to reactivate an account that was deactivated by FDA, please contact the FDA Industry Systems Help Desk.
Figure 4:
Confirm reactivation of the selected Subaccounts (Figure 5).
To confirm reactivation:
Figure 5:
The status of your Reactivate Subaccount request is displayed (Figure 6). When the process is complete, the system will display the following message: The account was successfully reactivated.
A new password for the reactivated Subaccount is sent to the Subaccount holder via e-mail (if an e-mail address was provided) or by U.S. Postal Mail if an e-mail address was not provided. Click the continue button to return to the FDA Industry Systems home page.
Figure 6:
You may promote a Subaccount to have full Account privileges on a temporary or permanent basis. This is useful if the primary Account holder is unavailable or needs assistance.
NOTE: The use of names, companies, cities, and countries are used fictitiously for the purpose of illustrating examples of how to complete the screens. Any resemblance to actual persons, living or dead, business establishments, events, or locales is entirely coincidental.
On the FDA Industry Systems home page, (Figure 10) select Edit Account Profile from the Account Management Menu.
Figure 10:
Choose the Subaccount you wish to promote ( Figure 11) and select Continue.
Figure 11:
In the Edit Account Profile screen (Figure 12) select the checkbox for Give Account Privileges then select Continue
Figure 12:
Review the information that you have entered for this Subaccount (Figure 13). If you are satisfied that the information is correct, select Submit. If you need to make further changes, select Modify to return to the edit account profile screen and make further edits.
Note: The message, Warning: This address was standardized, means that the system verified the address(es) you entered and added the correct 4 digits to the end of the Zip code. The application will be processed normally.
Figure 13:
The status of your request to promote the Subaccount is displayed (Figure 14). When the process is complete, the system will display the following message: The account profile was successfully updated. Click the button to return to the FDA Industry Systems home page.
Figure 14:
You may demote a Subaccount that has been promoted to Account status back to a Subaccount.
NOTE: The use of names, companies, cities, and countries are used fictitiously for the purpose of illustrating examples of how to complete the screens. Any resemblance to actual persons, living or dead, business establishments, events, or locales is entirely coincidental.
On the FDA Industry Systems home page, select Edit Account Profile from the Account Management Menu (Figure 15):
Figure 15:
Choose the Account you wish to demote and select Continue (e.g. Figure 16).
Figure 16:
Uncheck the box in the Edit Account Profile screen for Give Account Privileges then select Continue (Figure 17).
Figure 17:
Review the information that you have entered for this account (Figure 18). If you are satisfied that the information is correct, select Submit. If you need to make further changes, select Modify to return to the edit profile screen and make further edits.
Figure 18:
The status of your request to demote the account is displayed (Figure 19). When the process is complete, the system will display the following message: The account profile was successfully updated. Click the button to return to the FDA Industry Systems home page.
Figure 19:
