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.
1: FDA Industry Systems Page
The CECATS Main Menu page is 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.
Click Modify Application to
makes changes to a submitted, but not yet in Under Review status.
The following options are available:
To search using the application number, click Search Application. This option may be used to continue working on a draft application, to clone a previous application, or to make corrections to an application that is in 'Return for Action' status.
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, simply 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.
NOTE: For all applications in a 'Draft' status, if you do not perform any activity within 30 days, the status will automatically change to 'Not Submitted'. Please clone to continue the application.
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 the application type to be requested as shown in Figure 4.
4: Application Type
Select Certificate to Foreign Government (CFG).
Description of a Certificate to Foreign Government:
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.
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).
Acceptable CFG Marketing Statuses: 510(k), PMA, Exempt, Pre-amendment, Humanitarian Device Exemption (HDE), or Product Development Protocol (PDP) and DeNovo.
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-cfg-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
o 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.
o 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 change the status to 'Not Submitted' and may 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.
o Save & Continue– Information entered up to this point will be saved in 'Draft' status. An application number will be assigned 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.
o 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 are mandatory except marked as "Optional" in parenthesis. 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.
If the information is incorrect, click the 'FURLS Home' link as shown in Figure 6. Then click "Edit Account Profile" on the left-hand side and update your account profile accordingly.
The following two fields are required in section 1:
o 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 "Next". See Figure 7 below.
Figure 7: Section 1 - Requestor
At the next screen, you will need to
validate your address. This address is the requestor's address. It is not used
as the facility address on the application or for shipping. See Figure 9
Click "Accept validated address and continue" and click "Next" to proceed. See Figure 8 below.
Figure 8: Address Validation
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. Otherwise, please enter the Registration Number or the Owner Operator Number.
NOTE: In this section, you must identify all Manufacturers, Specification Developers, Repackagers/Relabelers, Remanufacturers, Reprocessor of Single Use Devices, Foreign Exporters, Contract Manufacturers, and Contract Sterilizers that are involved in the manufacturing process of devices on this request.
Additionally, if you include a Specification Developer then you must include the Contract Manufacturer for products on this request. Conversely, if you include a Contract Manufacturer, then the Specification Developer must also be included.
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
Owner Operator number (OON) entered:
As long as the OON is active, all facilities associated with the OON will be displayed. Select one or more facilities (if applicable) from the list of manufacturers that are in active status as shown in Figure 10 below. Inactive facilities will be grayed out and cannot be selected.
Registration number entered:
Only the single facility associated with that number will be displayed.
Figure 10: List of Manufacturers
o A facility may be entered only one time in section 2.
o 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), a review page for all manufacturers selected as shown in Figure 11.
Figure 11: Review Manufacturer List
Select the radio button to answer "Has this firm been inspected by FDA?"
To add additional manufacturer(s), click "Add Manufacturer".
To remove a manufacturer from the list, select the facility, click on the "X" icon and verify by selecting the "OK" button.
Optional: To enter the date of last FDA inspection for each manufacturer, click the pencil icon associated to the Firm and enter the Date of Last FDA inspection. See Figure 12 below.
Figure 12: Manufacturer Information
Once you have completed selecting all manufacturers, click "Next".
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.
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
Similar to the section 2, the establishment information will appear. If correct, click the facility and click "Add". If not correct, click "Previous". See Figure 14 below. Multiple distributors can be added.
Figure 14: Distributor List
o Only facilities in an active DRLM status can be chosen. An inactive facility will be grayed out.
o A facility may be entered one time only in section 3.
o NOTE: All distributors must have a U.S. Address. If you do not add a distributor in section 3, at least one manufacturer must have a U.S. Address. You will not be able to proceed to section 4 unless one manufacturer or distributor has a domestic address.
To add another distributor, click "Add Distributor".
To remove a distributor from the list, select the facility, click on the "X" icon, and verify by clicking the "Ok" button.
After all distributors have been identified, click on "Next".
After selecting the distributor(s), a review page of all distributors selected will be displayed as shown in Figure 15.
Figure 15: Review of Distributor List
In this section, you will be able to select one or more products from each manufacturer identified in sections 2.
o Class III products may be included only if all of the manufacturing facility(ies) have been inspected by the FDA. Failure to comply will prompt the FDA to immediately reject the certificate request application.
o Refurbished or remanufactured product may be listed on this application if the facility you represent is the original manufacturer. Additionally, the products must be identified as refurbished or remanufactured on the certificate.
Figure 16: Product Information
Select "Yes" or "No" to the question(s) regarding refurbished or remanufactured products.
A list of the manufacturers and distributors will be displayed as shown in Figure 17 below.
Figure 17: Product Information Listing
NOTE: You must add at least one product for each manufacturer.
To add a product, first click on the Pencil icon associated to the manufacturer. The product listings for that manufacturer (from DRLM) will be displayed. Select all the products for this facility that are to be included on the certificate.
IMPORTANT: 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.
At this point, you have an option regarding the addition of the product name. You can either enter the name of the devices exactly as you want it to appear on the certificate in the Proper Name block as shown in Figure 18 below OR you can wait until section 7 and upload a product list. 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.
To avoid the device name appearing on the certificate more than once, list the Proper Name of each device only once even if multiple firms have listings for the same device.
Figure 18: Selecting the Product
To remove a selected product from a facility, click on the edit icon/ pencil icon associated to the facility and deselect the box associated to the product and click "Next".
Once all products have been selected, click "Next".
All recalls (both open and closed) that have occurred within the past ten years for any product on the application must be identified.
After selecting 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
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 19 b: Recall Number Information
Click "Next" and the system will validate the recall number. If the number is valid, the Close-out Date field may get auto-populated.
If no Close-out Date was found for the recalled product, an option to upload the official Close-out Letter (from the FDA) will be provided. Please do not upload your firm's letter to the FDA. The accepted file formats include the following: pdf, bmp, jpeg, gif, pang, tiff, doc, and docx.
To upload the FDA Close-out letter, click Browse… and navigate to the file on your computer as shown in Figure 20 below
Figure 20: Attach Close-out Letter
Select the file and click "Upload". The uploaded file link will be displayed as shown in Figure 21 below. To remove the attachment, simply click "X" icon.
Figure 21: Uploaded Close-out Letter
Select one or more countries to indicate the product destination, click "Add" and repeat for additional countries 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
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.
Primary Facility: The primary facility is the facility which you represent. The primary facility must be a U.S establishment.
Click to view a list of all U.S. facilities entered in sections 2 and 3 as shown in Figure 24 below. Select the name of the facility that you represent.
NOTE: By selecting the facility that you represent, CECATS will pre-populate the facility name in the Exporter's Certification Statement which you will sign towards the end of the application.
Figure 23: Primary Facility and OON
For export certificates, the Owner Operator is a facility (Corporate Headquarters) that owns one or more registered manufacturer(s) or distributor(s) in DRLM. The owner operator cannot be identified with any manufacturing role since it does not have any manufacturing role identified in DRLM. The owner operator can only be identified as Owner Operator or Corporate Headquarters. The vast majority of export certificates do not include the owner operator.
NOTE: Only the Owner Operator of the primary facility may be included on the certificate.
To display the owner operator name and address for the primary facility, click "Yes" as shown in Figure 24 below. Select the appropriate Header Name from the dropdown list and click on "Next".
o Name of Owner Operator: appropriate if all of the establishments on certificate have the same owner operator in DRLM
o Manufactured for Owner Operator: appropriate if all of the establishments on certificate do not have the same owner operator in DRLM
o Name of Corporate Headquarters
Figure 24: Display Owner Operator
Address on the Certificate
NOTE: If the owner operator name or address is incorrect, Save & Exit the application and update the address information in the Online Administration Account (OAA) from the FURLS homepage. When you reenter CECATS to complete the draft application, you may need to remove the primary facility from section 2 and then re-add it for the updated information to be retrieved from DRLM.
SELECTING THE FACILITY TO BE PRINTED ON THE CERTIFICATE
A list of all manufacturers and distributors entered in section 2 and 3 will appear as shown in Figure 26. Select each facility that you want to appear on the certificate.
NOTE: At least one domestic (U.S.) facility must be printed on the certificate.
For each facility, choose the Header that will be printed on the certificate from the Header Name dropdown list as shown in Figure 25 below. If the same header is chosen, the facilities will be grouped together under the header.
Figure 25: Header Information
Subheaders: provide the option to identify the specific role the firm plays in regards to the products.
Optional: One or more subheaders may be selected for each facility to be printed on the certificate. Select the facility and click Pencil Icon as shown in Figure 26.
Figure 26: Subheader Information
Select the appropriate Subheader from the dropdown list and then click "Add" as shown in Figure 27 below.
Subheaders are optional. If no subheader is desired, leave as "—Please select—".
Figure 27: Subheader Dropdown List
To remove the Subheader, click "X" icon.
The following describes the Subheader rules:
Business As" (DBA)
All DBA or trade names for the establishment in DRLM will be displayed and you may choose one or more to be on the certificate. You will be given the option to choose one of the DBA names as the establishment names as well as if the Doing Business As wording is to appear.
Formatting: The DBA information will appear after the establishment name.
If CECATS does not show any DBA or trade names for the facility, the establishment registration must be updated to add a DBA name for the facility.
Known As" (AKA)
and "Address Also Known As" (AAKA)
Same basic function as described above for Doing Business As with Also Known As replacing the Doing Business As wording.
Formatting: The AKA information will appear after the establishment name.
Advanced function: You will have the option to enter up to three trade names with addresses under "Address Also Known As" Subheader.
Formatting: The AAKA information will appear after the establishment address.
· "Lens Finisher" or "Lens Finisher Manufacturer": 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.
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.
Known As", "Manufactured for", "Made for", or "A
Wholly Owned Subsidiary of":
When prompted, type in the Firm name and address, if desired.
o Firm name only: this information will appear below the establishment name and if applicable, below rule #2 and #4.
o Firm name and address: this information will appear below the establishment name and address.
When prompted, type in one or more Firm names and one address, if desired.
o Firm name(s) only: this information will appear below the establishment name and if applicable, below rule #2 and #4.
o Firm name(s) and single address: this information will appear below the establishment name and address.
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.
o "by" not included: this information will appear below the establishment name and if applicable, below rule #2 and #4.
o "by" include: the information will appear before the establishment name
Once the sub header details are entered, the system will display sub header details for each manufacturer and distributor as shown in Figure 28 below.
Figure 28: Subheader Information
Indicate What Product Information Should Appear on the Certificate
There are 2 ways to identify the names of the products to be included on the certificate (see Figure 29):
o Select "Use
Existing Product Listing (from section 4) to appear on the certificate" to
utilize the product's proper name as entered in section 4. (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.) This option is best if there are only a
couple devices with short names.
o Select "Upload your product name(s) and accessories". This option is best if there are many devices or models with long names.
Figure 29: Existing Product Listing or
Upload Product List (File)
To upload your product list (File), click on the "product worksheet" hyperlink as shown in Figure 30 to download a template which is in a format that must be used to upload your products.
Figure 30: Upload Hyperlink and Browse
Type or copy your product list onto the template. Please read the Tips below first.
Please adhere to the following rules or the system will not accept the upload:
o Rows 1 and 2 must not be deleted. (Product names typed on rows 1 and 2 will not appear on the certificate.)
o Please do not separate products with any blank rows. CECATS will automatically delete these blank rows on the certificate. 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.
o Please do not exceed the maximum character limit of 150 per cell.
o Once loaded into CECATS, the characters are displayed on certificates in Arial font with a size of 8.
o There is a single cell available for each product name with CECATS allowing each cell to be up to 150 characters. If you would like the appearance of columns within the one column format, a process called concatenation can be utilized. This can be accomplished using spreadsheet software such as (Microsoft Excel or Libre Office Calc) by concatenating multiple fields into a single field. Information on how to do this in Excel can be found in the Excel help. Basic concatenation instructions are provided below. For additional assistance, please contact FDA at email@example.com.
Concatenation – creating the appearance of multiple columns within a one column format.
For example, a company may store product information in a spreadsheet like this:
Using concatenation functions a company
might use a function in another column such as
=A2&" - "&B2&" - "&C2
This takes the values found in the cells A2, B2, and C2 and puts them together in a single cell with dashes (which can be changed to any type of separating text desired). The quotes around the dashes indicate that the text (and spaces) between the quotes are actual text to be displayed rather than a reference to a cell or function in the spreadsheet. This is the result of adding the function to cell D2:
Now that the cells with various product information have been concatenated, the concatenated information needs to be moved into a spreadsheet conforming to the CECATS template spreadsheet which is a single cell. Though the concatenation function displays the concatenated text, if this cell is copied to another spreadsheet the result will likely be an error displayed in the cell. This error occurs because the displayed concatenated text is still a function which requires the cells referenced in it to exist in the proper locations. Once the function is moved to a location where those referenced cells no longer exist, the function will not behave as expected. To copy the displayed concatenated text to the CECATS template spreadsheet, copy the text but when pasting the text, the option to past only values should be used. In Microsoft Excel, the option to paste only the values that are a result of a function is found in the Paste or Paste Special options. Pasting only values will allow concatenated text to appear correctly in the CECATS template spreadsheet:
When the product list is ready and saved to your computer, click "Browse…" and navigate to the location of your file and click "Upload". The uploaded products and accessories will be 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.
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 grouping just created will be displayed as shown in Figure 31 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.
"Add Product" button
You may add a new device at the beginning of the product list by clicking "Add Product". Click on "Add product", enter the Product Name and select "Next". The new product will be displayed at the beginning of the product list.
Figure 31: Grouping
NOTE: All products on the page must be grouped before moving to the next page 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.
If an error was
made when grouping, select "Clear Group" to restart grouping for that
NOTE: The "Clear Group" button will NOT affect any other pages (if more than 30 products).
"Clear All Groupings": will remove ALL groupings from all pages. A warning message will be appear 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 "Reupload Products" and all products and groupings will be removed. A warning message will appear prior to clearing the product listing. Once confirmed, upload a new product list. See Upload Product List (File) above.
"Restart Step 7" If for any reason you need to restart section 7, click on The "Restart Step 7". A warning message will appear prior to 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" including the Primary Manufacturer, Owner Operator Address, and 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 product groupings will be displayed for review as shown in Figure 32 below
Figure 32: Grouping Review Page
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:
o Identify only the specific country in section 6.
o 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 due to more than one country selected in section 6.
Enter the total number of certificates requested. See Figure 33 below.
Figure 33: Number of Certificates
The total fee will be displayed as shown in Figure 34.
NOTE: The FDA will invoice your firm quarterly for all certificates issued during the quarter.
Figure 34: Total Fee
The Exporter's Certification Statement (ECS) acknowledges that you, the 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 primary facility field will be auto-populated 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 35 below:
Figure 35: ECS
Once these fields are completed, click "Next".
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 36 below:
Figure 36: Additional ECS Documents
The uploaded documents will be displayed as shown in Figure 37 below. To remove a document, simply click "X" icon.
Figure 37: Additional ECS Documents with
Perform the same steps for any other facility. Once all the ECS documents have been uploaded, click "Next" to navigate to the final review page.
NOTE: The following are limitations for ECS Upload:
o The total file size of all ECS attachments cannot exceed 50 MB.
o 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 38.
Figure 38: Method of Delivery
The entire application broken out by section will be displayed as shown in Figure 39 below. You may choose to modify a section by selecting the "Edit" button next to the section to be updated. The data entered in the chosen section will be displayed and changes may be made as needed.
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),
Click to expand the list for that section.
Figure 39: Final Review Page
PREVIEW THE CERTIFICATE!!! To ensure that the facility name and address is appropriate, headers, subheaders, product list and groupings appear as preferred, click "Preview Certificate". If any changes are required, return to the appropriate section and update prior to continuing onto Section 9 to submit. Please see Figure 39 above.
This will be your final opportunity to make edits to some sections, so please review your completed application carefully.
NOTE: Your submission is not complete until you click "Submit".
Print Application: You may choose to print your application prior to submission using the "Print" button at the bottom of the page, however, unless you have previously saved the application, the application number will not appear on the printed application. There will another opportunity to print the application after it is submitted and has an application number assigned.
Submission: When your application is ready for submission, click "Submit". A message that your application was successfully submitted will appear as shown in Figure 40 below. An application number will be displayed and the opportunity to print a copy of the application is available. Please save the application 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.
NOTE: The order of the facilities on the final certificates may not be the same as the sample.
Figure 40: Submission Success Page