January 2024
Log into the FDA Industry Systems (FIS) https://www.access.fda.gov and select "CDRH Export Certification Application & Tracking System" (CECATS) from the list of systems available on the FURLS "Home" page, as shown in Figure 1.
Figure
1:
FDA Industry Systems Page
Select "Yes" in response to the question "Will the devices be exported from the United States?". Select "Continue" and the system will open the CECATS "Home" page. The CECATS Main Menu page is 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.
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, 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.
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.
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 the application type to be requested, as shown in Figure 4.
Figure
4:
Application Types
Select "Non-Clinical Research Use Only" from the dropdown list.
For a description of each application type, select the blue question mark icon located next to the application type list, shown in Figure 4 above.
The NCR Certificate is for the export of a non-clinical research use only product, material, or component that is not intended for human use which may be marketed in, and legally exported from the United States under the Federal Food, Drug, and Cosmetic Act (FD&C). Among the requirements to be met prior to the issuance of this certificate are the following:
A status bar at the top of every page will track your progress through each step of the application process, as shown in Figure 5 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-ncr-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 2). 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
NOTE: All Fields are mandatory except those 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.
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, click the "FURLS Home" link. 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:
Click "Next". See Figure 7 below.
Figure
7: Section 1 - Requestor Information
On the next screen, you will need to
validate your address. NOTE: This address is the requestor's address; It is not used
as the facility address on the application or for shipping.
Click "Accept validated address and continue" and click "Next"
to proceed to Step 2. See Figure 8 below.
Figure
8: Address Validation
In section 2, you are required to provide information on your manufacturing facility. The system prompts whether you have registered the facility with the FDA via the Device Registration and Listing Module (DRLM), as shown in Figure 9 below.
Figure
9:
Registered Facility
If the facility is registered, select "Yes" and click "Next". Enter either the Registration Number or Owner Operator Number (OON), as shown in Figure 10 below.
Figure
10:
Registration Number or OON
NOTE: You must enter a valid number in either field. If you cannot provide a valid number, you will not be able to continue with the application process and you must select "Previous" and select "No", as shown in Figure 9 above.
Entering a Registration Number
If you enter a (valid) registration number, the facility information including
the Firm Name, Address, Registration Number, and Current Status will be
displayed as shown in Figure 11 below.
Figure
11:
Display of Facility Information for entered Registration Number
Click "Add". The facility added to the application will be displayed as shown in Figure 12 below.
Figure
12:
Summary of Facility or Facilities added to the application
You have the ability to perform the following:
Click "Next".
As long as the OON is active, a list of 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 13. Inactive facilities will be grayed out and cannot be selected.
Figure
13:
Display of Facility Information for entered OON
NOTE: You will only be able to select a facility if the following conditions are met:
Once you have selected the facility or facilities involved, click "Add".
If the facility is not registered, select "No" and click "Next" (Refer to Figure 9 above).
Enter the Manufacturer name and address as shown in Figure 14 below.
Figure
14:
Enter Manufacturing Information
Once you have completed entering the
facility information, and click "Next"
OR
If you select "Yes" and click "Next", the system displays the facility
added to the application as shown in Figure 15 below.
Figure
15:
Summary of Facility added to Application
NOTE: If the manufacturer is the same as the requestor, then you will not have the option to "Edit" any information in this screen as shown in Figure 15 above.
Once you have entered your facility or facilities, click "Next".
Primary Facility: The primary facility is the facility which you represent. The primary facility must be a U.S establishment.
Click the icon to view a list of all U.S. facilities entered as shown in Figure 16. 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
16:
Primary Facility
Once you have selected the Primary Facility, click "Next".
Select the facility/facilities to be displayed on the certificate as shown in Figure 17 below. Click "Next".
Figure
17:
Facility to be displayed on the certificate
NOTE: You must select at least one manufacturer to appear on the certificate.
In this section, you will be able to add one or more products to the application.
Prior to selecting the products, identify whether you want to manually enter the products OR to upload your products as shown in Figure 18 below.
Figure
18:
Entering Product Information
Manually Enter Products
If you select "Manually Enter Products", all manufacturers selected in section 2 will be displayed as shown in Figure 19.
Click Pencil icon to add products for each establishment.
Figure
19:
Select Facility
Enter the product description and click "Add" as shown in Figure 20.
Figure
20:
Product Description
Repeat until products have been added for the specified facility. Click "Previous" button to return to the Product Information page as shown in Figure 19 above.
Repeat the steps for adding products for each facility (if applicable). Once you have completed adding products, click on "Next".
NOTE: You must enter at least one product for each facility before continuing to the next step.
Upload Products
To upload your product, click on the "product worksheet" hyperlink as shown in Figure
21 to download a template which is in a format that must be used to upload
your products.
Figure
21:
Upload Attachment
Type or copy your product list onto the template. Please read the Tips below first.
Tips for uploading products:
Please adhere to the following rules or the system will not accept the upload:
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 concatenated text to the CECATS template spreadsheet, copy the text. When pasting the text, the option to only past the values should be used. In Microsoft Excel, the option to only paste 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:
Once all of the products have been added to the template and the file is saved, click "Browse…" to navigate to the location of the file. Click "Upload". The product list will be displayed as shown in Figure 22.
Figure
22: Upload
products
You can add a new device at the
beginning of the product list by clicking "Add product".
Once you have completed adding/uploading products, click "Next".
Select one or more countries to indicate the destination. Once you have selected the country or countries, select "Next" to proceed as shown in Figure 23.
NOTE: Another method to select a country (other than scrolling down the list) is to select a country from the country list, then enter the first few letters of the desired country name. The system will jump to the country that begins with the letters entered.
Figure
23:
List of Countries
NOTE: The standard format of the electronic 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 "Next".
If more than one country was selected in section 4, you will not be able to select "Yes" to display the destination country on the certificate. If you wish to display a specific country on the certificate, you must either go back to section 4 and select only one country or create a new application with the desired country. Otherwise, select "No".
Enter the total number of certificates requested. See Figure 24 below.
Figure
24:
Number of Certificates Requested
Add number of certificates requested, the system will calculate the total fee as shown in Figure 25.
NOTE: The FDA will invoice your firm quarterly for all certificates issued during the quarter.
Figure
25:
Certificate Fee Amount
Click "Next".
The Exporter's Certification Statement (ECS) acknowledges that you, the responsible official or designee, certify that the facility(s) and the products identified in the "Supplemental Information" are (to the best of your knowledge) in substantial compliance with the FD&C 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 2. Select "I Agree" 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 26 below:
Figure
26:
ECS Page
Click "Next" to proceed to the Final Review Page.
The entire application broken out by section will be displayed as shown in Figure 27 below. You may choose to modify a section by selecting "Edit" next to the section to be updated. The data entered in the chosen section will be displayed and changes may be made as needed.
Figure
27:
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), click icon to expand the list for that section.
PREVIEW THE CERTIFICATE!!! To ensure that the facility name and address is appropriate, and that the headers, 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 6.
NOTE: The order of the facilities on the final certificates may not be the same as the sample.
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 an application number has been 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 28 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.
Figure
28:
Submission Success Page