3613k CFSAN eCATS Account Access

Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

U.S. Food and Drug Administration
CFSAN eCATS
Step-by-Step Instructions
https://www.access.fda.gov/

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Table of Contents
How to Access the CFSAN eCATS – New Accounts ............................................................... 3
Figure 1: Creating an FDA Industry Systems Account .......................................................... 3
Figure 2: Establishing Access to CFSAN eCATS .................................................................. 4
Figure 3: Opening CFSAN eCATS ....................................................................................... 5
How to Access the CFSAN eCATS – Existing FIS Account .................................................... 6
Figure 4: Establishing Access to CFSAN eCATS .................................................................. 6
Figure 5: Opening CFSAN eCATS ........................................................................................ 7
Enter New Application ................................................................................................................ 8
Figure 6: Login to FDA Industry Systems Account and Select CFSAN eCATS .................... 8
Figure 7: Select CFSAN eCATS for 801e Certificates ........................................................... 9
Figure 8: Select “Enter New Application” ............................................................................. 10
Figure 9: Select Product and Certificate Type ..................................................................... 11
Figure 10: Enter and Verify Requestor Information ............................................................. 12
Figure 11: Manufacturer Information and other optional Facility Information...................... 13
Figure 12: Identification of Manufacturing Facility ............................................................... 14
Figure 13: Confirm Name and Address Information ............................................................ 15
Figure 14: Identification of Additional Facilities (optional) .................................................... 16
Figure 15: Selecting Facililty Information to Display on Certificate ...................................... 17
Figure 16: Certificate Information ........................................................................................ 18
Figure 17: Product Details ................................................................................................... 19
Figure 18: Review Product Details ...................................................................................... 20
Figure 19: Additional Information ......................................................................................... 21
Figure 20: Signature Page ................................................................................................... 22
Figure 21: Application Review ............................................................................................. 23
Figure 22: Confirmation Page .............................................................................................. 24
Editing an Application .............................................................................................................. 25
Figure 23: Editing an Application ......................................................................................... 25
Figure 24: How to Edit an Application .................................................................................. 26
Cloning an Application ............................................................................................................. 27
Figure 25: Cloning an Application ....................................................................................... 27
Figure 26: Cloning Application Features .............................................................................. 28
Appendix I – Application Status and Action Matrix ............................................................... 29

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

How to Access the CFSAN eCATS – New Accounts
Figure 1: Creating an FDA Industry Systems Account

CFSAN eCATS is an FDA Industry System (FIS) and can be accessed via
https://www.access.fda.gov/. If you do not have an existing FIS account, click on the “+ Create
Account” button to create one. This will take you to the Create New Account screen where you
may select the Center and the systems you will need to access (Figure 2).
NOTE: You may wish to create a single account for all FDA submissions related to your facility
and to create subaccounts for personnel that will manage submissions to FDA. All submissions
by subaccounts will be accessible via the facility FIS account, which will allow continued access
to previous submissions in the event that an employee leaves the facility. For more information
on account management, please visit review the FDA Industry Systems User Guide: Account
Management.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 2: Establishing Access to CFSAN eCATS

On the Create New Account screen, select the Center for Food Safety & Applied Nutrition. In
the second section, select CFSAN eCATS as one of the systems you will need to access.
Continue filling out the application and submit. If you need detailed instructions for creating a
new account, please visit Create New Account Step-by-Step Instructions. Once you have
created an account and logged in, you will see the online account administration page for FDA
Industry Systems (see Figure 3).

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 3: Opening CFSAN eCATS

To access CFSAN eCATS, click on the name of the application (circled above).

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

How to Access the CFSAN eCATS – Existing FIS Account
If you have an existing FIS account, click on the blue “Log-In” button from the home page. After
logging in using your existing FIS login and password, select “Update System Access” from the
left side of the screen (see Figure 4).

Figure 4: Establishing Access to CFSAN eCATS

On the “Update System Access” page, select “CFSAN eCATS”. Click on “Next” and then click
on “Click Here to continue”. CFSAN eCATS will now be displayed on the online account
administration page for FDA Industry Systems with a check mark (see Figure 5).

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 5: Opening CFSAN eCATS

Once you have logged in, you will see the Online Account Administration (OAA) page for FDA
Industry Systems. To access CFSAN eCATS, click on the name of the application (circled
above).

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Enter New Application
Figure 6: Login to FDA Industry Systems Account and Select CFSAN eCATS

Once you have logged in, you will see the online account administration page for FDA Industry
Systems. To access CFSAN eCATS, click on the name of the application (circled above).

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 7: Select CFSAN eCATS for 801e Certificates

After logging into FIS and clicking on the CFSAN eCATS system, you will reach the landing
page where you will be asked to select one of three modules. To apply for a Certificate to a
Foreign Government or Certificate of Exportability click on the link for CFSAN eCATS (circled
above).

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 8: Select “Enter New Application”

To enter a new application, select “Enter New Application” from the menu on the left side of the
CFSAN eCATS home screen.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 9: Select Product and Certificate Type

You will be prompted to select the product type and the type of certificate for the application.
FDA acknowledges that some countries specifically require a “Certificate of Free Sale”, so you
may request to include “Certificate of Free Sale” as a subtitle on the Certificate to a Foreign
Government. If you would like this subtitle to be printed on your certificate, select Yes for the
question “Do you wish to include “Certificate of Free Sale” as a subtitle on the certificate(s)?”

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 10: Enter and Verify Requestor Information

In Section 1, Requestor Information will be auto-populated from the applicant's FDA Industry
Systems account information. You may indicate if the requestor information is the same as the
billing information, and if not, you will be prompted to provide billing information. After all
required information is entered, you may click next or select save and exit in the bottom right
corner.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 11: Manufacturer Information and other optional Facility Information

Next, you will be asked to identify the manufacturing facility for the products that will be listed on
the certificate. You will also have the option to identify an exporter, distributor, and consignor.
You may choose up to two entities to be listed on the certificate. To add a facility, click the “+”
icon in the row for the type of facility.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 12: Identification of Manufacturing Facility

You may identify the manufacturing facility by entering an FDA Establishment Identifier (FEI
number) or by selecting a Food Facility Registration (FFR) associated with your FIS/OAA
account.
If you represent a food facility, but do not see an option to identify this facility by the Food
Facility Registration, you may associate this facility with your account if you have the facility’s
Food Facility Registration number and PIN. To do this, click on the “Food Facility Registration”
link from the FURLS/FIS home page. Once the Food Facility Registration module opens, select
“Link Registration to your Account” on the left side of the screen and enter the facility’s Food
Facility Registration number and PIN.
If you choose to identify the manufacturing facility by the Food Facility Registration, the system
will display a list of all registered food facilities associated with your OAA account. Select the
correct facility for your application and click Next.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 13: Confirm Name and Address Information

Name and address information will be prepopulated based on the FDA records for the facility.
You may also provide contact information for the facility, but please be aware that any email
address you enter will receive all email notifications regarding this application. To proceed, you
may click Next or select Save and Exit in the bottom right corner.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 14: Identification of Additional Facilities (optional)

You may identify additional facilities by entering a DUNS or FEI number, selecting a Food
Facility Registration (FFR) associated with your FIS/OAA account, or manually entering
information to identify the exporter, distributor, and consignor. FDA/CFSAN only issues export
certificates for products exported from the United States, so only U.S. entities are eligible to be
listed on an export certificate as the exporter or consignor. See Figure 12 for more information.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 15: Selecting Facililty Information to Display on Certificate

Once you have identified the manufacturer and any other facilities you wish to include on the
application, you must select at least one facility to be displayed on the certificate. You may
choose up to two facilities to be listed on the certificate by clicking the checkbox in the row for
desired facility. After selecting which facility or facilities should appear on the certificate, you
may click Next or select Save and Exit in the bottom right corner.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 16: Certificate Information

Next, you will be prompted to identify the country of destination for the shipment and the number
of certificates requested for each country. All certificates associated with an application will
include the same product and shipment information; only the country name and the unique ID
for the certificate will vary. After all required information is entered, you may click Next or select
Save and Exit in the bottom right corner.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 17: Product Details

Section 4.1 will allow the applicant to provide product information for the products that will be
listed on the certificate. Certain fields will be required depending on the product type. After all
required information is entered, you may click Next or select Save and Exit in the bottom right
corner.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 18: Review Product Details

After entering all the product information for the first product, you will be able to review the
product list, edit product information and labels, and add additional products.
The applicant will also be able to select multiple headers that can be shown on the certificate
such as the value of the good(s), unit of measurement, the scientific name of the product(s), etc.
If there are multiple products in an application, headers can only be selected if all products have
information entered for the desired header. After all required information is entered, you may
click Next or select Save and Exit in the bottom right corner.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 19: Additional Information

After completing the prior section, you will have the option to add additional shipment details or
upload additional documents as may be required by the importing country. Please note that any
additional information provided in these sections will appear on all certificates associated with
an application. If you have added multiple countries on your application and require specific
shipment information for each country, then you must submit separate applications. After all
information is entered, you may click Next or select Save and Exit in the bottom right corner.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 20: Signature Page

The next screen displays the signature page that will be required for submission. To proceed
you must digitally sign and check the “I Agree” box. Note: The signature text varies depending
on the type of certificate requested. You may click Next or select Save and Exit in the bottom
right corner.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 21: Application Review
After entering all the information, you will be able to review the complete application and
preview the certificate before submission.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 22: Confirmation Page

After submission, you will receive a confirmation page and an application number that can be
used for future inquiries about the application.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Editing an Application
Figure 23: Editing an Application

After logging into FIS and clicking on CFSAN eCATS system, you will reach the home page. To
edit an existing application, select the edit icon (resembling a pencil) next to the application of
choice on your dashboard. You may edit any draft application or previously submitted
application as long as the application is not in “Pending Review” Status.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 24: How to Edit an Application

After selecting the edit icon, you will start at the beginning of the application and may edit any
previously provided information. Click through all the pages to resubmit your application. If you
represent a registered food facility and you have recently made updates to your Food Facility
Registration name and address, these edits will auto-populate when you select the pencil icon.
Be sure to click through all the pages to resubmit your application.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Cloning an Application
Figure 25: Cloning an Application

After logging into FIS and clicking on CFSAN eCATS system, you will reach the home page. To
clone an existing application, select the “Clone Application” icon (resembling two pieces of
paper) next to the application of choice on your dashboard. You may clone any previously
submitted application if it has not been rejected.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Figure 26: Cloning Application Features

After selecting the clone button, you will be brought to the beginning of your application where
you can review the application prior to submission and make edits to the application such as
adding or changing destination country information, quantities of shipments, the exporting
company, etc. What cannot be changed is the manufacturer information and adding new
product information. You may update the exporter, distributor, and consignor. If you do not wish
to make any edits to your cloned application, you may click submit.

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Step-by-Step Instructions for CFSAN eCATS
801(e) Certificates

Appendix I – Application Status and Action Matrix
Application Status: The Y indicates an external user can take the action for the associated
application status. The N indicates the action isn’t available for the associated application
status.

View
(Action)

Clone
(Action)

Edit
(Action)

Delete
(Action)

Print
(Action)

1. Draft

Y

N

Y

N

N

2. Pending Virus
Scan

Y

N

N

Y

N

3. Received

Y

Y

N

Y

N

4. Pending
Review

Y

Y

N

Y

N

5. Processed

Y

Y

N

N

Y

6. Rejected

Y

N

N

N

N

7. Under Review

Y

Y

N

N

N

8. Return for
Action

Y

Y

Y

Y

N

9. Updated
Pending
Review

Y

Y

N

Y

N

10. Canceled

Y

N

N

N

N

11. Withdrawn

Y

Y

N

N

N

Application Status

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