Search, Clone, or Modify an Application

March, 2019

Table of Contents

 

  1. Access CECATS
  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

 

Access CECATS

 

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 Systems Page
FIS Home page

Figure 2: CECATS Main Menu

 

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 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

Facility Type
Address, Line 1
Address, Line 2
City
State/Province/Territory
Zip Code
Country / Area
Application Status
Application Type

Figure 3: Search Parameters

 

Search Results

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.

Figure 4: 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.

View an Application

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

Modify an 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.

Clone an Application

To clone the application selects the double book icon.  Refer to Clone an Application section below for additional information.

 

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:

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)

o    You must edit section 9 to sign the application and upload a shipping label and any ECSs required.
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.

 

Modify a Submitted Application

 

Access CECATS and select "Modify Application" from the main menu.   (Refer to Figure 1 and 2 above).

STEP 1: Modify Application based on a notification received

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.

Figure 3: Modify Application

 

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.

Figure 4: 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.

Figure 5: Review Update Page

 

STEP 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.

o    Received

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.

Figure 6: Update the number of certificates

 

A list of all applications that can be updated will be displayed as shown in Figure 7.

Figure 7: Select Application

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.

Figure 8: Update Number of Certificate

 

STEP 3: Modify Application - 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:

o    Received

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.

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.

Figure 10: Cancel the Application Warning

Once confirmed, the application will be cancelled and an email notification sent. See Figure 11.

Figure 11: Cancel Success Message