Create a Medical Device Certificate Application Step-by-Step Instructions

March , 2014

Return to Online Registration1

Table of Contents

  1. Section 1 Create a Medical Device Certificate Application
  2. Section 2 Navigation
  3. Section 3 Section 1 Requestor Information
  4. Section 4 Section 2 Manufacturer Information
  5. Section 5 Section 3 Distributor Information (if applicable)
  6. Section 6 Section 4 Product Information
  7. Section 7 Section 5 Was the product ever recalled?
  8. Section 8 Section 6 List country(ies) for which the Certificates are requested
  9. Section 9 Section 7 Indicate what product information should appear on the certificate
  10. Section 10 Section 8 Should the country destination be listed on the certificate?
  11. Section 11 Section 9 Exporter’s Certification Statement
  12. Section 12 Review Screen

Create a Certificate Application

 

Log into the FDA Industry Systems 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 CECATS Main Menu page as shown in Figure 2 below.

Figure 2: CECATS Main Menu
CECATS home page

To create a new application , click Enter New Application from the list of options. Skip the Modify and Search sections below to continue.
Click Modify to makes changes to a submitted, but not yet in Under Review status.

  • Change the number of certs
  • Upload corrected Exporter’s Certification Statement (ECS)
  • Cancel request

NOTE: For all applications in a “Draft” status, if you do not perform any activity within 30 days, the system will automatically cancel and delete the application.

  • To continue working on an application in a draft status, select the radio button next to the corresponding application and select “Complete Draft Application”.
  • To clone an application -create an application based on an existing application , select the radio button next to the corresponding application and click Clone Application. Refer to the Clone Application section in this document for further instructions.

Figure 3: Submitted and Draft Application View
Draft Applications

The Center for Devices and Radiological Health (CDRH) issues several types of Export Certificates and letters. When creating a new application, select which certificate type, letter, or notification to be requested as shown in Figure 4.

Figure 4: Certificate Types
Certificate Types

Select Certificate to Foreign Government (CFG) or Certificate of Exportability 801(e)(1) or 802.


Description of each Certificate Type:

For a description of each certificate type, select the red question mark icon located next to the certificate type list shown in Figure 4 above.

NOTE: At this time the Certificate to Foreign Government (CFG) and the Certificate of Exportability 801(e)(1) or 802 are the only certificate types that can be requested online. For all other letter and notification types, please fill out and send the appropriate application form to the following address:


U.S Food and Drug Administration
Center for Devices and Radiological Health
Export Certificates
10903 New Hampshire Avenue
Building 66, Room 2621
Silver Spring, MD 20993-0002

Certificate to Foreign Government (CFG)

A Certificate to Foreign Government is issued for legally marketed devices in the United States that are in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C).

Eligibility Note:

  • Are cleared or approved by FDA for marketing in the U.S.
  • May be legally commercially distributed in the U.S.
  • May be a Class I, II, or III device
  • Are listed with the FDA
  • All devices must be exported from the United States

Acceptable CFG Marketing Statuses: 510(k), PMA, Exempt, Pre-amendment, Humanitarian Device Exemption (HDE), or Product Development Protocol (PDP).

Certificate of Exportability 801(e)(1)

The Certificate of Exportability Section 801(e)(1) is for the export of products not approved for marketing in the United States that meet the requirements of Section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act. Among the requirements to be met prior to the issuance of this certificate are the following:

  • The manufacturing facility must be in compliance with the registration requirements.
  • The device must be in compliance with the listing requirements.
  • The device must meet the requirements of Section 801(e)
    • accords to the specifications of the foreign purchaser.
    • is not in conflict with the laws of the country to which it is intended for export.
    • is labeled on the outside of the shipping package that it is intended for export.
    • is not sold or offered for sale in domestic commerce.

In addition, the U.S. Exporter must comply with the laws of the importing country.

Certificate of Exportability Section 802 *****

The Certificate of Exportability Section 802 is for the export of products not approved for marketing in the United States that meet the requirements of Section 801(e)(1) and Section 802 of the Federal Food, Drug, and Cosmetic Act. Among the requirements to be met prior to the issuance of this certificate are the following:

  • Class II and III devices only
  • Devices are not approved or cleared by FDA for marketing in the U.S.,
  • Manufacturing establishments meet Good Manufacturing Practices (GMP) regulations and
  • The manufacturer must be registered with FDA.
    The manufacturing facility must be in compliance with the registration requirements
    The device must be in compliance with the listing requirements
    The device must meet the requirements of Section 801(e):
    accords to the specifications of the foreign purchaser
    is not in conflict with the laws of the country to which it is intended for export
    is labeled on the outside of the shipping package that it is intended for export
    is not sold or offered for sale in domestic commerce

In addition, the U.S. Exporter must comply with the laws of the importing country.

Navigation

 

At the top of every page during the Enter New Application process, a status bar will track your progress through each step of the online application process as shown in Figure 5 below.

Figure 5: Navigation Bar
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. 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
Navigation Bar

  • Back -Navigates back one screen or back one step. . Information entered on the current screen will NOT be saved if you select the “Back” 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.
  • Continue to Step X - All information is saved on the current screen and navigates to the beginning of the next step. Though the information is saved and you can navigate back to a previous screen, exiting CECATS without using the “Save & Exit” button will cause the loss of the entire request.
  • Cancel & Start Again- The system will return you to the screen where you selected the Certificate Type. All information you have entered will NOT be saved.

NOTE: Fields marked with an asterisk (*) 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 system auto-populates specific information from your Online Account Administration (OAA) into section 1 (Requestor Information) of the application. These fields cannot be edited in CECATS.

If the information is incorrect, select the “OAA” hyperlink as shown in Figure 7 and make the necessary updates to your contact information in your Online Account Administration. Once you have updated your account, log back into CECATS and verify the correct information has been auto-populated into section 1.

The following two fields are required in section 1:

  • Title
  • Firm Tax ID Code (also referred to as the Employer Identification Number or EIN (a nine-digit numeric value). This number is assigned by the Internal Revenue Service (IRS).

Click on “Continue to Step 2” button.

Figure 7: Section 1 - Requestor Information
Address Validation

Before proceeding to step 2, you will need to validate your address. The system will display the “Validated Address” if there are minor differences to the requestor address. 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 “Continue” to proceed to Step 2. See Figure 8 below.

Figure 8: Address Validation
Address Validation

Section 2 - Manufacturer Information

 

The FDA requires that all facilities manufacturing medical devices must be registered in the FDA Device, Registration and Listing Module (DRLM). Once a manufacturer is registered in DRLM, the FDA provides an Owner Operator Number to the requesting firm. The FDA also assigns a Registration Number for every manufacturer registered in DRLM. If you have not registered your manufacturer in DRLM, return to the FURLS home page and register your manufacturer in DRLM.

NOTE: For export certificates, the Owner Operator is a facility that owns one or more registered manufacturer(s) or distributor(s) in DRLM. An owner operator does not itself have any listings. Only facilities that perform manufacturing roles have listings. Therefore, an owner operator cannot be identified on an export certificate with any manufacturing or distribution role. The owner operator can only be identified as Owner Operator or Corporate Headquarters.

The system will first prompt you to enter the following information:

  • Registration Number
    OR
  • Owner Operator Number

Enter the Registration Number or the Owner Operator Number (OON) and click on the “Retrieve Registration” button. See Figure 9.


Figure 9: Registration Number or OON for Manufacturer
Registration Number or OON for Manufacturer

Owner Operator number (OON) entered:
As long as the OON is active, the system will display all facilities associated with the OON. Select one or more facilities (if applicable) from the list of manufacturers that are in active status as shown in Figure 10 below

Registration number entered:
Only the single facility associated with that number will be displayed.

Figure 10: List of Manufacturers
List of Manufacturers

  • The system will not allow you to select any facility in an inactive status. The inactive facility or facilities will be grayed out.
  • The system will not allow the user to select a facility that has already been selected for the same application.
  • After selecting one or more manufacturing facilities associated with your Owner Operator number, you have the option to add one or more facilities associated with a different Owner Operator Number.

After selecting the manufacturer(s), the system will provide a review page for all manufacturers selected as shown in Figure 11.

Figure 11: Review Manufacturer List
Review Manufacturer List

Identify additional manufacturers by clicking on the “Add” button. Enter the appropriate Registration number or OON as previous.

To remove a manufacturer from the list, click on the radio button next to the Firm Name, click on “Remove”, and verify by selecting the “Continue” button.

Optional: Enter the date of last FDA inspection for each manufacturer selected by selecting the radio button next to the Firm Name, clicking on “Edit” and enter the Date of Last FDA inspection. See Figure 12 below.

Figure 12: Manufacturer Information
Manufacturer Information

OOnce you have completed selecting all manufacturers, click on “Continue to Step 3”.

Section 3 - Distributor Information


 

In section 3, you have the option to enter one or more Distributors to your request. This is the U.S. establishment that exports the devices from the United States. Do not include foreign distributors.

The system will first prompt you to enter the following information:

  • Registration Number
    OR
  • Owner Operator Number

Enter the Registration Number or the Owner Operator Number (OON) and click on “Retrieve Registrations”. See Figure 13 below.

Figure 13: Registration Number or OON for Manufacturer
Registration Number or OON for Manufacturer

Owner Operator number (OON) entered:
As long as the OON is active, the system will display all facilities associated with the OON. Select one or more facilities (if applicable) from the list of distributors that are in active status as shown in Figure 10 below.

You can select one or more facilities from the list of distributors that are in a active status as shown in Figure 14.

Registration number entered:
Only the single facility associated with that number will be displayed.

Figure 14: Distributor List
Distributor List

  • The system will not allow you to select any facility in an inactive status. The inactive facility or facilities will be grayed out
  • The system will not allow the user to select a facility that has already been selected for the same application.

To add another distributor, click on the “Add” button and enter the Registration number or OON as prompted. See Figure 15 above.

To remove a distributor from the list, click on the radio button next to the Firm Name, click on “Remove”, and verify by selecting the “Continue” button.

After all distributors have been identified, click on “Continue to Step 4”.

NOTE: At least one manufacturer or distributor must be a domestic firm in order to proceed to the next step.

After selecting the distributor(s), the system will display a review page of all distributors selected as shown in Figure 15.

Figure 15: Review of Distributor List
Review of Distributor List

Section 4 –Product Information


 

In this section, you will be able to select one or more products from each manufacturer identified in sections 2 and 3.

Prior to selecting your products you should carefully read the following statements regarding products:

  • You may list Class III products only if all of the manufacturing facility(ies) has been inspected by the FDA. Failure to comply will prompt the FDA to immediately reject the certificate request application.
  • Any refurbished or remanufactured product listed on this application cannot appear on the certificate unless the manufacturer(s) of refurbished device(s) on your request are the original manufacturer of the device(s).

Figure 16: Product Information
Product Information

Once you have answered questions regarding refurbished or remanufactured products as shown in Figure 16 above, the system will display all manufacturers and distributors added in section 2 and 3 as shown in Figure 17 below.

Figure 17: Product Information Listing
Product Information Listing

NOTE: You must add at least one product for each manufacturer.

Add Products

To add a product, first select the manufacturer and click on the Add/Remove Product button. The system will display the product listing for that manufacturer (from DRLM). Select the radio button corresponding to the product(s) you wish to add. Once you have selected the checkbox, you will also be able to enter the Proper Name as shown in Figure 18 below.

Figure 18: Selecting the Product
Selecting the Product

IMPORTANT: Please select all the products for this facility that are to be included on the certificate. If any product is not listed on the facility’s establishment registration, the facility will need to update their DRLM registration before you can continue.

Next, enter the proper name of the devices exactly as you want it to appear on the certificate. If multiple firms have listings for the same device and you list the proper name more than one time, it may appear on the certificate multiple times also. List the proper name of each device once. If you want to include product codes, parts/accessories to the product listing, do not indicate a Proper Name in this section. Instead, in section 7, upload the product information using the formatting outlined in that section.

Perform the same steps to add a product or products for each manufactures (if applicable).

NOTE: You are not required to add a product to a distributor.

To remove a product from a facility, select the facility and click on “Add/Remove Product”. Deselect the corresponding radio button and click on “Continue.

Once all products have been selected, click on “Continue to Step 5” to proceed.

Section 5 – Was the product ever recalled?


 

In this section, if any product listed has been recalled in the past ten years, you are required to enter the FDA issued recall number or you may enter your internal reference number for a recall awaiting Z number assignment, and close out date of your recall, if applicable.

First select the checkbox next to the product. A new button will appear. Click on the “Add/ Modify Recall Info” button as shown in Figure 19a.

Figure 19a: Selecting a Product that has been recalled
Recalled Products

Enter the following Recall Number information: • FDA Issued Recall Number • Close-out Date • Internal Reference Number, if no FDA recall number has been issued yet.

NOTE: The format of the recall number is Z-XXXX-YYYY. Please enter the eight-digit number as shown in Figure 19b below.

Figure 19b: Add Recalled Information
Recalled Products

Click on “Continue” and the system will validate the recall number. If the number is valid, the Close-out Date field may get auto-populated.

However, if no Close-out Date was found for the recalled product, an option to upload the official Close-out Letter will be provided. Failure to do so may cause a delay in the certificate processing.

Click on the Browse… button and navigate to the file on your computer as shown in Figure 20 below

Figure 20: No Close-out Letter
Close-out Letter

Select the file and click on “Upload”. The system will display the link as shown in Figure 21 below. To remove the attachment, simply click on the “Remove” button.

Figure 21: Attach Close-out Letter
Attach Close-out Letter

NOTE: The total file size of all Close-out letter attachments cannot exceed 50MB (Megabytes). The accepted file formats include the following: pdf, bmp, jpeg, gif, png, tiff, doc, and docx.

Click on the “Continue to Step 6” button to proceed.

Section 6 – List Country(ies) for which the Certificates are requested

 

This section is required.

*NAME OF COUNTRY or COUNTRIES - Select one or more countries to indicate the product destination. Once you have selected the country or countries, select “Continue to Step 7” to proceed as shown in Figure 22.

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.

Figure 22: List of Countries
List of Countries

NOTE: The standard format of the printed certificate will not display an individual country name, but will state “foreign countries”. To display a specific country on the certificate, select only one country in section 6 AND indicate that country destination should be listed on the certificate in section 8.

Click on the “Continue to Step 7” button to proceed.

Section 7 – Indicate what product information should appear on the certificate.


 

Primary Facility

The primary facility is a required field. The primary facility will appear on the certificate. Select the primary facility from the dropdown list. The list will contain all U.S. facilities entered in sections 2 and 3 as shown in Figure 23 below.

Figure 23: Primary Facility and OON Address
Primary Facility and OON Address

NOTE: The Owner Operator must be registered as the owner of each facility to be included on the certificate.

The system provides the option to display the owner operator address for the primary facility by selecting “Yes” as shown in Figure 24 below. Please select the appropriate Header Name from the dropdown list and click on “Continue”.

  • Name of Owner Operator (All of the establishments on certificate have the same owner operator in DRLM.)
  • Manufactured for Owner Operator (All of the establishments on certificate do not have the same owner operator in DRLM.)
  • Name of Corporate Headquarters
Figure 24: Display Owner Operator Address on the Certificate
Figure 24: Display Owner Operator Address on the Certificate

NOTE: The default value has been set to “Name of Owner Operator” and the system displays the Owner Operator Address. If the Owner Operator Address is incorrect, Save & Exit the application and update the address information in the Online Administration Account (OAA) from the FURLS homepage.

SELECTING THE FACILITY TO BE PRINTED ON THE CERTIFICATE

Click the radio button beside each facility that should appear on the certificate.

NOTE: At least one domestic (U.S.) facility must be printed on the certificate.

Header Name
For each facility, choose the Header Name that will be printed on the certificate from the Header Name dropdown list as shown in Figure 25 below.

Figure 25: Header Information
SubHeader Information

Subheader Information Optional: One or more Subheaders may be selected for each facility to be printed on the certificate. Select the radio button next to the facility and click on the “Add/Remove Sub Header” button as shown in Figure 26.

Figure 26: Subheader Information
SubHeader Information

Select the appropriate Subheader from the dropdown list and then click on the “Add” button as shown in Figure 27 below.

Figure 27: Subheader Dropdown List
Subheader Dropdown Lis

To remove the Subheader, click on the “Remove” button.

Subheader Rules

The following describes the Subheader rules:

  1. Subheaders are optional. Leave as “Please Select” if no Subheader is desired.
  2. “Doing Business As” (DBA) or “Also Known As” (AKA) as a Subheader: The system will display all DBA or trade names for the establishment in DRLM and you may choose one or more to be on the certificate. If there is no DBA name associated to the facility, select another Subheader Name OR go to the DRLM module and associate a DBA name with the facility. You will be given the option to choose one of the DBA names as the establishment name. Formatting: The DBA or AKA information will appear after the establishment name.
  3. “Lens Finisher” or “Lens Finisher Manufacturer” as a Subheader: May only be chosen for the Primary Facility. When prompted, type in both the name and address of the facility. Formatting: The establishment name and address will appear after all other establishment and Subheader information.
  4. “a division of” as a Subheader:
    When prompted, type in the division name.
    Formatting: This information will appear after the establishment name and after any DBA or AKA chosen, but before the address.
  5. 5. “Formerly Known As”, “Manufactured for”, “Made for”, or “A Wholly Owned Subsidiary of”:
    When prompted, type in the Firm name and address, if desired.
    Formatting:
    • Firm name only: this information will appear below the establishment name and if applicable, below rule #2 and #4.
    • Firm name and address: this information will appear below the establishment name and address.
  6. 6. “Previously Manufactured at” as a Subheader:
    When prompted, type in one or more Firm names and one address, if desired.
    Formatting:
    • Firm name(s) only: this information will appear below the establishment name and if applicable, below rule #2 and #4.
    • Firm name(s) and single address: this information will appear below the establishment name and address.
  7. “Made for” as a Subheader:
    When prompted, type in the Firm name and address.
    Option: Select “by” to add the word “by” on the certificate immediately following the firm’s address.
    Formatting:
    • “by” not included: this information will appear below the establishment name and if applicable, below rule #2 and #4.
    • “by” include: the information will appear before the establishment name

Use Existing Product Listing (from section 4) to be printed on the certificate.

There are 2 ways to identify the names of the products to be included on the certificate (see Figure 28):

  • Select the first radio button to utilize the product’s proper name as entered in section 4 to be printed on the certificate.
  • If a proper name was not entered, please go back to section 4 and enter the proper name or choose to upload a product list.
  • Select the second radio button to uupload a product list.
Figure 28: Existing Product Listing or Upload
Existing Product Listing or Upload

Upload Product List (File)

Click on the “product worksheet” hyperlink as shown in Figure 29 to download a template which is in a format that must be used to upload your products.

Figure 29: Upload Hyperlink and Browse
Upload Hyperlink and Browse

Additional directions / rules have been provided in the product template excel file. Please adhere to the following rules or the system will not accept the upload:

  1. Rows 1 and 2 must not be deleted.
  2. Please do not separate products with any blank rows. Grouping of products can be achieved by entering a dot or dash on the line in between the group. This dot or dash will appear on the certificate.
  3. Please do not exceed the maximum character limit of 90 per cell.

If these rules are NOT followed, the upload function will fail and NO products will be uploaded to the application.

When the product list is ready and saved to your computer, click on the “Browse…” button and navigate to the location of your file. Click on the “Upload” button. The system will display all product accessories ready for grouping.

NOTE: The order of the products printed on the certificate will be the same order of the products entered in Section 4 or on the product template upload file.

Grouping a Product(s) to a Facility(ies)
Products can be grouped to one, some or all of the facilities to be printed on the certificate.

NOTE: The associations you create will impact the printout of your certificate.

NOTE: There is a checkbox located at the top-left section of the Products table. If this box is checked, all products will be selected for that particular page.

“Group All Products to All Facilities” Button
The “Group All Products to All Facilities” Button provides a quick and easy way to group all products to all facilities with a single click.

“Group” Button
Select one or multiple products from the list of products. Then select one or more facilities located to the right of the product listing. When finished, click on the "Group" button.

The system will display the grouping just created. See Figure 30 below.

The system continues to display the product listing (below the grouping). Products that have been “grouped” will now be grayed out. Continue grouping the remaining products until all products on the page have been grouped.

Figure 30: Grouping
Grouping

NOTE: The system will only display 30 products per page. If the product list contains more than 30 products, you must group the 30 products before moving onto the next set of products.

Once you have grouped all products on that page, click on the “Next” button to continue grouping additional products. Continue until all products on all pages have been grouped.

“Clear Group” Button

If an error was made when grouping, select “Clear Group” to restart grouping for that particular page.
NOTE: The “Clear Group” button will NOT affect any other pages (if more than 30 products).

“Clear All Groupings” Button

The “Clear All Groupings” button will remove ALL groupings from all pages. The system will provide a warning message prior to clearing all groupings. Once confirmed, you will have to start the grouping process.

“Reupload Products” If changes to the product list are required after the initial product upload, click the “Reupload Products” button and all products and groupings will be removed. The system will provide a warning message prior to clearing the product listing. Once confirmed, the system will navigate to the upload page. See Upload Product List (File) above.

“Restart Step 7” Button If for any reason you need to restart section 7, click on The “Restart Step 7” button. The system will provide a warning message below prior restarting step 7. Once confirmed, the system will navigate back to the start of step 7.

Warning: All information will be deleted if you click on the “Restart Step 7” button including the Primary Manufacturer, Owner Operator Address, all identified facilities to be printed on the certificate, Header and SubHeader selections, and the product listing.

Once all products have been grouped to a facility or facilities, the system will display the product groupings for review as shown in Figure 31 below

Figure 31: Grouping Review Page
Grouping Review Page

Click on the “Continue to Step 8” button to proceed.

Section 8 – Should the country destination be listed on the certificate?


 

Unless otherwise indicated in this section, the certificate will be state “into foreign countries.” Sometimes a specific destination country name is desired. To have a specific country appear:

  • Identify only the specific country in section 6.
  • Select “Yes” to the “Should the country destination be listed on the certificate” in section 8.

NOTE: If this option is greyed out and cannot be chose, most often it is because more than one country was selected in section 6.

Enter the total number of certificates requested. See Figure 32 below.

Figure 32: Number of Certificates Requested
 Number of Certificates Requested

Prior to Step 9, the system will calculate the total fee as shown in Figure 33.

Figure 33: Total Fee
 Total Fee

Preview the certificate To ensure that the headers, subheader and product list and groupings appear as preferred, click Preview Certificate to view the certificate. If any changes are required, return to the appropriate section and update prior to continuing onto Section 9.

Section 9 – Exporter’s Certification Statement (ECS)


 

The Exporter’s Certification Statement (ECS) acknowledges that you, th responsible official or designee, certify that the facility(s) and the products identified on the Supplemental Information are to the best of your knowledge in substantial compliance with the Federal Food, Drug, and Cosmetic Act (the Act) and all applicable or pertinent regulations.

In this section, the system auto-populates the primary facility field based on the selection you made in section 7. You must select the “I Agree” button located at the bottom of this section and enter your name and title. You will not be able to continue with the application until these fields have been completed. See Figure 34 below:

Figure 34: ECS
ECS

Once these fields are completed, click on the “Continue” button.

Every establishment listed on the certificate must provide a signed ECS. If the establishments are related, i.e. have the same owner operator in DRLM, the same signed ECS can be upload for all of the related establishments.

NOTE: The following is the link to the FDA 3613 CFG form including the ECS document: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM052378.pdf

Where prompted, upload a signed ECS document for each facility by clicking on the Browse button next to the facility, select the file, and click on “Upload” in section 7 as shown in Figure 35 below:

Figure 35: Additional ECS Documents
Additional ECS Documents

The system will display the link as shown in Figure 36 below. To remove the attachment, simply click on the “Remove” button.

Figure 36: Additional ECS Documents with Link
Additional ECS Documents with Link

Perform the same steps for any other facility. Once all ECS documents have been uploaded, click on the “Continue” button to navigate to the final review page.

NOTE: The following are limitations for ECS Upload:

  • The total file size of all ECS attachments cannot exceed 50 MB.
  • The accepted file formats include the following: pdf, bmp, jpeg, gif, png, tiff, doc, and docx.

Method of Delivery

You must select the method of delivery. Select the carrier and attach a complete return label as shown below in Figure 37.

Figure 37: Method of Delivery
Method of Delivery

Final Review Screen


 

The system will display the entire application broken out by section (See Figure 38 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 your chosen section. You may make changes as needed.

At this time, you may preview your certificate in order to make sure that your product information, manufacturer/distributor information is displayed to your satisfaction on the certificate and attachment pages, by clicking the button “Preview Certificate”. Please see Figure 38 below. Through clicking this button, you also will be able to see the approximate number of certificate and attachment pages for your completed certificate in order to guesstimate cost information.

NOTE: Your submission is not complete until you click the “Submit” button.

This will be your final opportunity to make edits to some sections, so please review your completed application carefully.

Figure 38: Final Review Page
Final Review Page

NOTE: The system displays one entry in each section. If you entered multiple entries in a section, (I.e. Multiple manufacturers or distributors in section 2 or 3), the system will display a downward arrow button at the bottom right of that section. Click on the downward arrow button to expand the list for that section.

You may choose to print your application prior to submission. Select the “Print Application” button located at the bottom of the review page. A new browser window will open which will allow you to print the application. When you are finished, close the browser window in order to return to the CECATS application.

You may also select “Preview Application” so that you may have a better view of the layout of your certificate and the number of pages included in your certificate, though this is not final until after your certificate has been reviewed.

When your application is ready for submission, click on the “Submit” button also located at the bottom of the review page. The system will display a message that your application was successfully submitted as shown in Figure 39 below. The system will provide you with an application number. Please save this number for future reference. The application number will be required to check the status of your application. You will also receive an email confirmation that your application has been successfully received along with the application number.

Figure 39: Submission Success Page
Submission Success Page

Clone An Application


 

The cloning feature allows a user to copy any submitted application including the CFG, 801(e)(1), and the 802. 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” status can be cloned. This includes any application in a “Rejected” or “Cancelled” status.
  • An application cannot be submitted without updating the Exporter’s Certification Statement.

To clone an application, select "Enter New Application" from the main menu (Refer to Figure 2). After selecting the “Enter New Application” option, the system will display all applications that you have saved and or submitted. All saved applications will be in a “Draft” status until you submit the application. You will also be able to see the most current status for all applications that have been submitted. If your list becomes too large, the Search function is viable option to quickly locate a specific application.

If you wish to clone an application, select the radio button next to the corresponding application and click on “Clone Application” button located at the bottom of the list of applications.

The system will display the entire application broken out by section (Refer to Figure 38). 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 your chosen section. You may make changes as needed.

When your application is ready for submission, click on the “Submit” button also located at the bottom of the review page.

NOTE: Remember to update section 9 or you will not be able to submit the application.

Once submitted, the system will display a message that your application was successfully submitted (Refer to Figure 35). The system will provide you with a NEW application number. Please save this number for future reference. The application number will be required to check the status of your application. You will also receive an email confirmation that your application has been successfully received along with the application number.

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