Log into the FDA Industry Systems https://www.access.fda.gov and select 'CDRH Export Certification Application & Tracking System' from the list of systems available on the FURLS Home Page as shown in Figure 1.
1: FDA Industry Systems Page
The system displays CECATS Main Menu page as shown in Figure 2 below:-
2: CECATS Main Menu
To create a new application, click Enter New Application. All applications that you have saved or submitted will be displayed as shown in Figure 3 below. Applications that are saved, but not submitted will be in "Draft" status until you submit them.
You may select "Modify Application" (when applicable) or "Search Application" for an existing application from the main menu.
NOTE: Return for Action status indicates that upon review of the application by the FDA, additional information or clarification was required. CECATS will send an email to the requestor with comments from the reviewer and will provide a 48 hour window for modifications to be made. If modifications cannot be made within 48 hours, the status will automatically change to "Incomplete". Please clone the application when ready, modify and submit. A new application number will be assigned. No charges are incurred for an application unless certificates are issued.
3: Submitted and Draft Application View
The Center for Devices and Radiological Health (CDRH) issues several types of Export documents. When creating a new application, select which application type to be requested as shown in Figure 4.
4: Application Type
Select Export Permit Letter.
Description of an Export Permit Letter:
For a description of each application type, select the question mark icon located next to the Application Type dropdown list shown in Figure 4 above.
Export Permit Letter
To obtain an Export Permit Letter, which affirms the FDA's approval to export devices in accordance with section 801(e)(2) of the FD&C Act, a request should include the following information:
To view the definitions of the application types, click on the question icon located next to the application type list. The system will display in a new window with a description of each application type. The system displays the following detailed instructions/requirements necessary for an Export Permit Letter as shown in Figure 5 below.
5: Export Permit Letter Details
A status bar at the top of every page will track your progress through each step of the application process as shown in Figure 6 below.
A "Get Help" icon, located at the top right of each page, will provide page specific help. For an overview of all help files available, please refer to the FDA Industry Systems Index of Help Pages at https://www.access.fda.gov/cecats/help/cecats-epl-guide.html.
Also located the top right corner of each page is a "FURLS HOME" link that will take you to the FURLS Home Page. The "CECATS HOME" link will take you to the CECATS Home Page (Refer to Figure 1). To log out of the system, select "FURLS HOME" and click on logout.
At the top and bottom of each screen are navigation buttons as shown in Figure 6 below.
NOTE: All Fields except marked as "Optional "in parenthesis are mandatory fields. You will NOT be able to proceed to the next step or Save & Exit until all mandatory fields have been properly entered on the current screen.
The requestor is the owner of the account from which the application is filed and the person requesting the Export Permit Letter. The requestor is responsible for completing and signing the application form.
Most of the fields in section one are automatically populated based on the information from your Online Account Administration (OAA) and cannot be edited in CECATS. If the information is incorrect, you can click on the "FURLS Home" link, located in the top right corner. Then select "Edit Account Profile" on the left-hand side and update your account profile accordingly.
Once you have updated your account, log back into CECATS and verify your changes.
NOTE: The Title field is required in section 1.
Once you have completed these fields, click on "Next". See Figure 8 below.
8: Section 1 - Requestor Information
The requestor's address will be displayed and validated. If the address is incorrect, you will need to exit the application and make the necessary updates to your Online Account Administration. Otherwise, select the "Accept validated address and continue" radio button and click on "Next" to proceed to Step 2. See Figure 9 below.
9: Address Validation
The manufacturing company is the company that manufactures one or more of the products. This company can be the same as the requestor. The system prompts whether your manufacturing name and address are the same as the requestor name and address as shown in Figure 10 below.
10: Manufacturing Name and Address same as Requestor Name and Address
If you select 'No', you must fill out the manufacturing information fields as shown in Figure 11 below.
11: Manufacturing Information
NOTE: For an Export Permit Letter, you can add only one manufacturer per application.
Once you have entered all required fields, click on the 'Next' button to proceed.
In section 3, you are able to add your product information. Enter the Name of the Device and indicate if there are any accessories included as shown in Figure 12 below.
Optional: You may enter the IDE Number for your product.
12: Product Information
Once you have entered all required fields, click on the 'Next' button to proceed.
Please select one of the radio buttons as shown in Figure 13 below.
13: Country Selection
If you selected "Select an individual country or countries" the system displays a table of all countries as shown in Figure 14 below.
NOTE: Another method to select a country (other than scrolling down the list) is to first click on a country from the country list and then type in the first few letters of the desired country name. The system will jump to the country that begins with the letters typed. You also have the option to hold down the "CTRL" button and select multiple countries.
14: List of Countries
Once you have selected the country or countries, click 'Next' to proceed.
For an Export Permit Letter you must provide Foreign Liaison information as shown in Figure 15 below.
15: Foreign Liaison Information
Click on the edit icon from the Action column corresponding to each country. See Figure 16 below.
Figure 16: Foreign Liaison Information per country
Identify the Name, Title and Organization, Address and Phone Number of the person signing the Letter of Acceptance for each country identified. Click Add, you shall see the Foreign Liaison Information updated for the specific country. See Figure 17 below.
Figure 17: Foreign Liaison Information updated
Foreign Liaison Information is required for all selected importing countries. Repeat the process for all importing countries you have selected before in your EPL application. Click on 'Next' to proceed.
For an Export Permit Letter, you must provide the Export Permit Letter Request (Cover Letter) and the Letter of Acceptance for the specific country or the European Union as shown in Figure 18 below.
Select the 'Browse' button and then select your file to be uploaded. Once you have selected your file, click on 'Upload'. If successful, the system will display your filename as a hyperlink as shown in Figure 19 below.
19: Attachments successfully uploaded
Once you have attached the required documents, click on 'Next' to proceed.
Section 5 continued - Additional Attachments
You have the option to attach additional documents to your application or you can continue to the next section by clicking on "Next".
If you decide to add additional documents, you are required to select the Document Type from the dropdown and upload the attachment as shown in Figure 20 below:
20: Load attachments
Select the file, click on Browse, select the file to be uploaded and click on "Upload". The system will display the link as shown in Figure 21 below. To remove the attachment, simply click on the "X" icon.
Figure 21: Attachments successfully uploaded
NOTE: If you select "Other" in the Document Type dropdown list, you must provide a description of the attachment.
Section 5 continued - Method of Delivery
Select the method of delivery (UPS or FedEx) and attach a complete return label as shown below in Figure 22 below.
22: Method of Delivery
Once this section is completed, click on "Next" button to proceed to the Final Review Page
The system will display the entire application broken out by section as shown in Figure 23 below. You may choose to modify a section by selecting the 'Edit' button next to the section to be updated. The system will re-display the data entry screen corresponding to the chosen section. You may then make changes as needed.
23: Final Review Page
NOTE: The system displays one entry in each section. If multiple entries are entered in a section, (I.e. Multiple attachments in section 5), click on the downward arrow button to expand the list for that section.
You may choose to print your application prior to submission by selecting the "Print Application" button located at the bottom of the review page. However, the printed document will not have the application number assigned. The application number will be included if you click "Submit first and then click "View Complete Application" and "Print Application".
NOTE: Printing the application will print the contents of the application itself and not a final Export Permit Letter. When finished, close the browser window in order to return to the CECATS application.
The system will display the application number and a message that the application was successfully submitted as shown in Figure 24 below. Please save this number for future reference. The application number will be required to check the status of the application. An email confirmation will be sent stating that the application has been successfully received along with the application number.
24: Submission Success Page