Table of Contents
After you have logged in to FDA Industry Systems, choose "Certificate Application Process" from the list of systems available on the FURLS Home Page as shown in Figure 1.
To modify an application, select “Modify Application” from the list of options on the CAP Home Page. See Figure 2 below.
Select one of the options available to modify the application as shown in Figure 3.
Based on the option selected in Figure 3, the system will display only those applications that are both associated with this account and in the correct application status.
To choose a particular application, select the hyper linked Application Number to view options for modifying that application as shown in Figure 4.
At the top and bottom of each screen are 3 buttons:
- Continue - Go to the next screen and continue modifying the application.
- Review Changes - Returns you to the Review Screen page for final review before submission.
- Cancel & Start Again - Returns to the Review Screen page. Any updates you have made to the application will be lost.
If the application has been set to Return for Action, the FDA has determined that your application cannot be processed until you make certain corrections to the application. The system will display the application at the Review Screen Page with an Edit button next to each section. The system will also display the option ‘Attach Additional Documents’ to add the supporting documents in your application. See Figure 5 below. Once you have updated the specific sections of your application, you will be able to resubmit the application. The system will send an email notification as a confirmation to the application update in addition to the online screen confirmation page.
This option allows you to request for an additional certificate or certificates for an application that is in Received, Accepted, Updated Pending review, Pending review status for non OCAC offices . This option allows you to request for an additional certificate or certificates for an application that is in Pending review, Under Review, Return for Action, Return for Action Hold, Status Pending Rejection, and Pending Complete for OCAC. The system will allow you to modify Section 7 of an existing application. This is the section where you can enter additional certificates you would like to request. All other sections of the application will not be editable. In addition, you will not be able to request additional certificates if the application is more than six months old. See Figure 6 below.
Select the "Edit" button for Section 7 to request for additional certificates.
Enter the number of additional certificates you are requesting, and then select “Continue.”
The system re-displays your application showing the new number of requested certificates. Click on “Submit” to request the additional certificates. The system will display a message that your application was successfully submitted.
This option allows you to copy or “clone” any existing application (regardless of application status).
NOTE: Be sure to remember that each application is based on the Registration Number and PIN. You will NOT be able to edit the manufacturing name and address in section 1 of the application. Also, you will not be able to change the certificate type when cloning from an existing application. Therefore, it is important to know the facility (Registration Number and PIN) and certificate type for the application that you will be cloning.
Once you have identified and selected the application you wish to clone, the system will display the application with an Edit button next to each section as shown in Figure 5. Click on the “Edit” button next to the section you wish to modify. Make the necessary changes to each section (if necessary).
When you have updated all sections, click on the “Submit” button. The system will save your changes as a new application and provide you with a new Application Number. The system will provide an additional email notification confirmation with application details.
Cancel an application
This option allows you to ‘cancel’ the application that is in ‘Return for Action ‘status. The system will display the applications associated to your account. Once you click on the hyperlink the system will provide a warning before cancelling the application.