Creating a user account, and the benefits of doing so

Although a Safety Reporting portal is not required for accessing many of the features for submitting a safety report Any adverse-event report, product problem or complaint report, as well as a product-use error report. The safety report is also known in the Portal as a "submission." (See also "ICSR.") we recommend that you create a user account to benefit from being able to:

• Expedite completion of your report

• Save a report and return to finish later

• See a list of your incomplete and submitted reports

• Provide follow-up reports more easily

To create a user account, click the Create Account button under the Account Benefits heading on the Portal Home page. Please provide the requested information, keeping in the following points:

• Be sure to accurately complete fields marked with an asterisk (*). This information is required by the application in order to process your request, and for us to get back to you with information about your user account, and for responses to any questions you may have.

• Company Information: Your organization may be registered with the US Food and Drug Administration (FDA) and have an FDA identifier, such as with FDA’s Electronic Registration and Listing System (FURLS), or the Food Facility Registration Module (FFRM). If so, providing your company’s FDA identifier and Registration Type—or a DUNS number—will enable the Portal to recognize you uniquely, and to more effectively support your reporting needs.

• Your contact information: This information set includes your address, telephone numbers, etc.

 Please note:  Your email address Identifies a location to which electronic mail (e-mail) messages can be delivered. is essential! The account-acknowledgement email that you receive in order to access the system will be sent to the email address you provide. Additionally, your email address is your username The name that is employed by a Portal user to identify themselves when logging onto the application. Both a username (user ID) and a password are required. In the Safety Reporting system, the username corresponds with the email address provided by the user when they first registered for an account. which, together with your password A "key" (a collection of keyboard characters, known only to the user) that allows the system to confirm the user’s identity by matching their password to their username. (The system never displays the password.), is used to authenticate you when you log into your user account.

After you've entered all your information, submit your request. The system will respond shortly thereafter with an email message acknowledging your account activation and providing you with a link to a Web page on which your account and username will be acknowledged, and on which you  will be requested to enter a password.