Log into the FDA Industry Systems and select "CDRH Export Certification Application & Tracking System" (CECATS) from the list of systems available on the FURLS Home Page as shown in Figure 1.
Figure 1: FDA Industry
Figure 2: CECATS Main
The Search Application option allows you to search your applications by various criteria. Once you have found the application, you can modify the application, update the number of certificate requests, or print the application.
To search for an application, click "Search Application" from the CECATS Main Menu Page. Refer to Figures 1 & 2 above.
NOTE: It is best to search by only one criterion. If you have the application number, only insert this info since it provides the most accurate search possible.
You can search using any or all of the
following fields as shown in Figure 3:
Application Number - Unique number provided by CECATS after the initial submission
Registration Number - Unique number associated to a specific facility. This number is provided by the CDRH district offices
Owner Operator Number - Unique number associated to a company. Multiple facilities can have the same OON.
Facility Name - Name of the Manufacturer or Distributor
Address, Line 1
Address, Line 2
Country / Area
The results corresponding to the search criteria will be displayed as shown in Figure 4 below.
NOTE: If your OAA account is an Enterprise-Level account, you will be able to search on all applications that pertain to your account and any sub-account applications.
If your OAA account is Sub-account, you will only be able to search on applications that pertain to your account.
The application number, Submitted Date,
Status, and the Application Type will be displayed. If the application was not
modified or corrected, the Submitted Date will be the same as the Date of
You can use the up and down arrows in the column headings to sort the application list in ascending or descending order.
To view an application, click on the eye
icon next to the
Once the application is displayed, you can print a copy of the application.
To modify an application, select the pencil icon and choose Modify Application Type.
See the Modify Application or Update Number of Certificate sections below for additional information.
To clone the application selects the double book icon. Refer to Clone an Application section below for additional information.
The cloning feature allows a user to copy any submitted application. Once cloned, the user will have the ability to update any or all sections of the application prior to submission.
o Applications in any status except "Draft" status can be cloned. This includes any application in a "Rejected" or "Cancelled" status.
o An application cannot be submitted without updating the Exporter's Certification Statement. (Applies to CFG, Certificate of Exportability Section 801(e)(1) or Section 802, and Non-Clinical Research Use Only certificate)
o A new shipping label will need to be provided. (All applications except Simple Notification.)
To clone an application,
o Access CECATS and select "Enter New Application" from the main menu. (Refer to Figure 1 and 2 above).
o Click clone application icon associated to the application number. All sections will be editable. (Refer to Figure 39)
must edit section 9 to sign the application and upload a shipping label and any
NOTE: If your list of applications becomes too large, the Search function is viable option to quickly locate a specific application or you can use Ctrl+F to search for the application while in the Enter New Application screen.
o When your application is ready for submission, click "Submit".
Once submitted, the application will be assigned an application number and you will receive an email stating your application was successfully submitted. Please save the application number for future reference. The application number will be required to check the status of your application.
Access CECATS and select "Modify Application" from the main menu. (Refer to Figure 1 and 2 above).
The application has been returned for action due to an issue with the application. Select the Modify Application option from the main menu and select "Modify application based on a notification received" option as shown in Figure 3.
A list of all applications that can be modified will be displayed as shown in Figure 4. Select the appropriate application and click on the pencil icon next to the application.
Select an application to modify
On the application review page, shown in Figure 5 below, select the Pencil icon (Edit icon) next to the section to be updated. Continue through all sections and 'Submit' the application from the Final Review Page.
Review Update Page
This option allows the number of certificates requested to be updated on an application that has already been submitted. However, in order to perform this update, the application must be in one of the following statuses.
o Ready for Review
o Return for Action
To change the number of certificates requested, select the Modify Application option from the main menu and then select "Update the number of certificates" option as shown in Figure 6.
Update the number of certificates
A list of all applications that can be updated will be displayed as shown in Figure 7.
Select the application to update and on the Final Review Page, click Pencil icon next to the appropriate section as shown in Figure 8 below. Once updated, "Submit "the application from the Final Review Page.
Update Number of Certificate
This option allows an application to be cancelled. In order to cancel an application, the application must be in one of the following statuses:
o Ready for Review
o Return for Action
Select the Modify Application option from the main menu and then select "Cancel Application" as shown in Figure 9.
Cancel the Application
NOTE: To be able to cancel an application, its status must be in a Received, Ready for Review, or Return for Action. Any other status means you will not be able to cancel the application. Furthermore, you will be responsible for any cost associated to the issuance of the certificate requested.
Once the application has been selected, a warning message will be displayed prior to cancelling an application as shown in Figure 10.
Cancel the Application Warning
Once confirmed, the application will be cancelled and an email notification sent. See Figure 11.
Cancel Success Message