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FDA Industry Systems User Guide: Account Management Questions and Answers

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Do I need an account?

You only need an account if you wish to make submissions to FDA electronically via the Internet. FDA strongly encourages electronic submissions, which will be quicker and more convenient for both facilities and FDA. An account gives you a User ID and password, allows you to manage your FDA submissions online, and keeps your information secure. However, if you choose to make submissions to FDA by other means, such as on paper (by mail or FAX) or by CD-ROM, you do not need an account.

Who can create an account?

Anyone can create an "Account". "Accounts" are the initial accounts established through the electronic system. Only Account holders can create "Subaccounts" linked to their Account. The Account holder would establish Subaccounts to allow others access to the company's submissions.

What is the difference between an Account and a Subaccount?

The difference between an Account and a Subaccount is the amount of account information available to each type of account. An Account acts as the administrator for a group of Subaccounts for your company. The Account can create Subaccounts, update account information for any of its 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 are optional. The ability to create Subaccounts is provided as a convenience for those companies that wish to designate additional personnel to manage submissions to FDA.

Who should have an Account?

Those companies that want to make submissions to FDA electronically should designate at least one person to have an Account. For a company that intends to create Subaccounts for its employees, the Account holder should be a trusted person employed by the company creating the account who can act as the administrator for the company's accounts.

Who should have a Subaccount?

Because Subaccount holders may have access to sensitive company information contained in the system, Subaccount holders should be trusted personnel employed by the company creating the account. For companies that do not want to create Subaccounts, the Account may be sufficient for managing your submissions to FDA.

How many Subaccounts do I need/may I have?

You may have as many as you wish or none at all. Subaccounts are optional. The ability to create Subaccounts is provided as a convenience for those companies that wish to designate additional personnel to manage submissions to FDA.

 May I have more than one Account to manage the same Subaccounts?

Yes, your company may have more than one Account to manage the same Subaccounts by promoting a Subaccount to an Account. 

My company has facilities in several locations. Do I have to create a separate account for each one?

No. Accounts are for the people who will be managing the submissions.You can create one "Account" for the company as a whole to manage all your submissions or you may create "Subaccounts" to manage each location's submissions or groups of locations' submissions.

I could create one "Account" for the company, and "Subaccounts" for each location. But I'd like each location to have its own "Account." May I do that?

Yes. It is only a matter of how much control you wish to maintain over your submissions. Account holders have greater control over how Subaccounts are linked to submissions than do the Subaccount holders. For instance, Account holders can move facility registrations from one Subaccount to another, while Subaccount holders are limited to linking facility registrations for which they have the registration number and PIN to their own accounts. Subaccount holders can, however, indicate when creating a registration, whether they wish to allow their Account to have access to the registration they have created. Accounts created separately (and not through promoting a Subaccount) will not automatically have access to each other's Subaccounts and submissions.

May I have multiple Accounts?

You should not create two Accounts with the same contact information. There is absolutely no need to do so.

I'm going on a long vacation. May I designate someone to handle my account and submissions for me while I'm gone?

There is no need to have someone else manage your account. Your account only contains information about you. However, if you wish to have someone else manage your submissions, the easiest way is to create a Subaccount for this person. If you do not want the individual to have access to all your submissions (for instance all facility registrations) you may give an account holder the registration numbers and PINs of only the ones you want them to manage so they can access and update the registrations.

If I deactivate a Subaccount, who can reactivate the Subaccount?

If you, the Account holder, deactivate a Subaccount, you can reactivate that Subaccount. Any other Accounts with access to the Subaccount could also reactivate the Subaccount. FDA can also reactivate and deactivate Subaccounts. If the Subaccount was deactivated by FDA, you will not be able to reactivate the account. Contact the FDA Industry Systems Help Desk if you have questions or believe a Subaccount has been deactivated in error.

I forgot my password. How can I get a new one?

Go to the Reset Password page. When you provide the correct answer to your "Secret Question" a new password will be mailed to you. If you provided an e-mail address, it will be sent there. Otherwise it will be mailed via postal mail to the account holder's mailing address.

What are non-alphanumeric characters?

Non-alphanumeric characters are symbols such as @, #, $, and %.

I got sent back to the Login screen, and all my information disappeared. What happened?

For security reasons, the session is set to "time out" after a certain period of inactivity. You must login again. Any information you entered during the session when the timeout occurred is lost.

Why do I keep getting an "invalid password" message when I try to choose a password?

The password that you want to use to login to FDA Industry Systems. Passwords must meet ALL of the following requirements:

Some examples of valid passwords would be #Congratulation$, Fri1end2ship3Hights@, *Check(9)boxes-2023-Unchecked. 

Note: to keep your data secure, do not use these examples as your password.

At least 15, but no more than 32 characters.

At least one UPPERCASE letter.

At least one lowercase letter.

At least one special character: ~ ! @ # $ % ^ * ( ) _ - + = { } [ ] | : ; " , ?. Do not use <>& or '.

At least one number.

What is the difference between an Account ID and a Registration Number?

An Account ID is specific to you, as a person. You use it, along with your password, to gain access to all of the FDA Industry Systems. An Account ID is sometimes also known as a "User ID" or "Username". Its sole purpose is to keep your information safe from modification by unauthorized individuals. If you wish, you can also create Subaccounts for other people to help you with your Registrations and other FDA Industry Systems, but that is completely optional. Most people will not need to do this.

A Food Facility Registration Number is specific to a particular food facility. One person, with one Account ID, can register as many Food Facilities as he or she needs to. Each facility should have exactly one registration number and PIN. Together, these allow you to give permission to other people (with other Account IDs) to manage your registrations.

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