Create an Export Permit Letter Application

May, 2019

Table of Contents

 

  1. Create an Export Permit Letter
  2. Navigation
  3. Section 1 Requestor Information
  4. Section 2 Manufacturer Information
  5. Section 3 Product Information
  6. Section 4 List country(ies) for which the Export Permit List is requested
  7. Section 5 Attachments
  8. Review Screen

 

Create an Export Permit Letter

 

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.

Figure 1: FDA Industry Systems Page
FIS Home page

 

The system displays CECATS Main Menu page as shown in Figure 2 below:-

Figure 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.

  • To create a new application, click "Enter New Application" from the main Menu Page and then Click on "Enter New Application " button.
  • To continue working on a draft application, click on Pencil icon  (Edit icon) associated to the desired application.
  • To clone a previous application, click on the double book icon  (Clone icon) next to the application number.
  • Verify the information on each page is still correct and continue through all screens.

 

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.

 

Figure 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.

Figure 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:

    • A complete description of the device intended for export;
    • The status of the device in the U.S., e.g., whether it is investigational, banned, etc.,
    • A statement indicating that the requestor conducted a search of the Medical Literature Analysis and Retrieval System database (see instructions below) and a summary of the search results, as well as a summary of safety data to demonstrate that export of the device will not endanger the public health and safety, or documentation of exemption from this requirement (see below), and
    • A letter from the appropriate foreign liaison (person with authority to sign a letter of acceptance for the foreign government) identified in the CDRH Foreign Liaison Listing12, which must be either in English or accompanied by a certified English translation, stating that:
      • The device is not in conflict with the laws of the country to which it is intended for export;
      • The foreign government has full knowledge of the status of the device in the U.S.; and
      • Import is permitted or not objected to

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.

Figure 5: Export Permit Letter Details

 

Navigation

 

 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.

Figure 5: Navigation Bar

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.

 

Figure 6: Navigation Buttons

    • Previous -Navigates back one screen or back one step. Information entered on the current screen will NOT be saved if you select the "Previous" button.
    • Save & Exit– Information entered up to this point will be saved. Your application will be set to a "Draft" status until you complete and submit the application. If you do not perform any activity for 30 days, the system will automatically cancel and delete the application. When you log into the CECATS system, all applications in a "Draft" status will be displayed after selecting the "Enter New Application" option from the main menu.
    • Save & Continue– Information entered up to this point will be saved in 'Draft' status. The system will generate the application number when you click on the 'Save and continue' button the first time and this number shall be visible on the top of the screen until the application is submitted. Please keep the Application number for your records and for any communications with FDA regarding this application. Your application will be set to a "Draft" status until you complete and submit the application. If you do not perform any activity for 30 days, the system will automatically change the status to 'Not Submitted' and may delete the application.
    • Next - All information is saved on the current screen and navigates to the beginning of the next step. However, exiting CECATS without using the "Save & Exit" button will cause the loss of the entire request.

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.

 

Section 1 - Requestor Information

 

 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.

Figure 8: Section 1 - Requestor Information

 

Address Validation

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.

Figure 9: Address Validation

 

Section 2 - Manufacturer Information

 

 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.

Figure 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.

Figure 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.

 

Section 3 - Product Information

 

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.

Figure 12: Product Information

 

Once you have entered all required fields, click on the 'Next' button to proceed.

 

Section 4 – List Country(ies) for which the Certificates are requested

 

Please select one of the radio buttons as shown in Figure 13 below.

 

Figure 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.

Figure 14: List of Countries

 

Once you have selected the country or countries, click 'Next' to proceed.

Foreign Liaison Information

For an Export Permit Letter you must provide Foreign Liaison information as shown in Figure 15 below.

Figure 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.

 

Section 5 – Attachments

 

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.

Figure 18: Attachments

 

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.

Figure 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:

Figure 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.

Figure 22: Method of Delivery

 

Once this section is completed, click on "Next" button to proceed to the Final Review Page

 

Final Review Screen

 

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.

Figure 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.

Figure 24: Submission Success Page