Table of Contents

 

1. Access CECATS or CDNE Portal
2. Search for an Application
3. Clone an Application
4. Modify an Application  Step 1: Modify the Application based on a notification received
5. Modify an Application  Step 2: Update the Number of Certificates
6. Modify an Application  Step 3: Cancel the Application

 

1 Access CECATS or CDNE Portal

 

Log into the FDA Industry Systems (FIS) https://www.access.fda.gov 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 Systems Page

Select “Yes” in response to the question “Will the devices be exported from the United States?”. Select “Continue” and the system will open the CECATS “Home” page. The CECATS “Main Menu” page is shown in Figure 2 below

Figure 2: CECATS Main Menu

Select “No” in response to the question “Will the devices be exported from the United States?”. Select “Continue” and the system will open the CDNE “Home” page, as shown in Figure 3.

Figure 3: CDNE Home Page

 

2 Search for an Application

 

The "Search Application" option allows you to search your applications by various criteria. Once you have found the application you can modify, update the number of certificate requests, or print the application.

To search for an application, click "Search Application" menu option from the CECATS or CDNE "Home" page, as shown in Figure 4.

Figure 4: Search Application

NOTE: It is best to search by only one criterion. If you have the application number, only insert this information; it provides the most accurate search possible.

You can search using any or all of the following fields as shown in Figure 5:

• Application Number - Unique number assigned by the applicable system.
• Registration Number - Unique number associated to a specific facility – this number is provided by the CDRH district offices.
• Owner Operator Number (OON) - Unique number associated to a company – multiple facilities can have the same OON.
• Facility Name - Name of the Manufacturer or Distributor, if applicable
• Application Type
• Application Status
• Facility Type
• Address, Line 1
• Address, Line 2
• Country / Area
• Zip Code
• City
• State/Province/Territory

Figure 5: Search Parameters

 

Search Results

The results corresponding to the search criteria will be displayed (Figure 6).

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 a sub-account, you will only be able to search applications that pertain to your account.

Figure 6: Search Results

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 Application".

You can use the up and down arrows in the column headings to sort the application list in ascending or descending order.

2.1 View an Application

To view an application, click on the View (eye) icon  next to the application number. Once the application is displayed, you can print a copy of the application.

2.2 Edit an Application

To edit an application, select the Edit (pencil) icon .Applications may be edited while in Draft or Return for Action.

If the application is in Return for Action status, after selecting the Edit icon Figure 9 is displayed and you can choose the appropriate modification to be performed. See the “Modify Application” or “Update Number of Certificates” sections below for additional information.

2.3 Clone an Application

To clone the application, select the Clone (double book) icon.  Refer to the "Clone an Application" section below for additional information.

 

3 Clone an Application

 

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.

NOTE:

• Applications in any status except "Draft" can be cloned.
• An application number will be assigned and will appear at the top of the new application.

To clone an application,

• Select the "Enter New Application" menu option from the CECATS or CDNE Home page, as show in Figure 7.
• Click the Clone icon associated to the application number. All sections will be editable.
• An application cannot be submitted without updating the Billing Information, Manufacturer Information (e.g., Inspection Details), and the Exporter's Certification Statement (CECATS) or Shipper's Certification Statement (CDNE).
• A new shipping label will need to be provided.

NOTE: If your list of applications becomes too large, the Search function is a viable option to quickly locate a specific application. You can also use Ctrl+F to search for the application while on the "Enter New Application" screen.

Before submitting the application, click "Preview Certificate" to ensure the firm and device information appears as desired.

When your application is ready for submission, click "Submit".

Once submitted, you will receive an email stating your application was successfully submitted.

NOTE: Please save the application number for future reference. The application number will be required to check the status of your application.

Figure 7: Enter New Application

 

4 Modify a Submitted Application

 

Select the "Modify Application" menu option from the CECATS or CDNE "Home" page, as shown in Figure 8.

Figure 8: Modify Application

4.1 Option 1: Modify Application based on Notification Received

To address the FDA reviewer's comments identified in a return for action notification, select the "Modify Application" and select "Modify application based on a notification received" , as shown in Figure 9.

Figure 9: Modify Application based on Notification Received

A list of all applications that can be modified will be displayed, as shown in Figure 10. Select the appropriate application and click on the Edit icon

Figure 10: Select an Application to Modify

On the "Application Review" page, as shown in Figure 11, select the Edit icon next to the section you wish to update. Continue through all sections and submit the application from the "Final Review" page.

Figure 11: CDNE Application Review Page

 

4.2 Option 2: Update the Number of Certificates

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:

• Received
• Ready for Review
• Return for Action

To change the number of certificates requested, select the "Modify Application" and select "Update the number of certificates" option as shown in Figure 12.

Figure 12: Update the Number of Certificates

 

A list of all applications that can be updated will display, as shown in Figure 13.

Figure 13: Select Application

Select the application to update on the "Final Review page" and click the Edit icon next to the appropriate section, as shown in Figure 14. Once updated, submit the application from the "Final Review" page.

Figure 14: Update Number of Certificate

 

4.3 Option 3: Cancel Application

This option allows an application to be cancelled. In order to cancel an application, the application must be in one of the following statuses:

• Received
• Ready for Review
• Return for Action

Select the "Modify Application" and select "Cancel Application", as shown in Figure 15.

Figure 15: Cancel the Application

 

NOTE: If an application is in "Under Review" or "Printing in Progress" status, contact the reviewer identified in the Under Review notification. Once the certificates are printed on the security paper, the application cannot be cancelled. You will be responsible for any cost associated to the issuance of the certificate(s) requested.

Once the application has been selected, as shown in Figure 16, a warning message will display prior to cancelling an application, as shown in Figure 17.

Figure 16: Cancel the Application – Application List

Figure 17: Cancel Warning Message

Once confirmed, the application is cancelled as shown in Figure 18 and an email notification will be sent.

Figure 18: Cancellation Success Message