0750 Form FDA 3997 user guide

Accreditation of Third Party Certification Bodies to Conduct Food Safety Audits and Issue Certifications

0750 Form FDA 3997 user guide

OMB: 0910-0750

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U.S. Food and Drug Administration
Accredited Third-Party Certification Program
Portal
Electronic User Guide
Step-by-Step Instructions for an Accreditation
Body to Apply for and Manage Recognition
Status in the Program

Table of Contents
1

Introduction........................................................................................................................1

2 Overview of FDA Portals for Electronic Accredited Third-Party Certification Program
Submissions.............................................................................................................................1
3

Create an FDA Online Account .........................................................................................2

Submit an Application for Recognition as an Accreditation Body (AB) ............................ 14

Apply for Recognition and Implementing FDA Regulations ............................................. 17

Application Returned for Further Action .......................................................................... 37

Reconsideration Request ................................................................................................ 45

Add or Manage Third-Party Certification Bodies (CBs) ................................................... 58
Add Accredited Third-Party CB ................................................................................ 59
Update Accredited Third-Party CB ........................................................................... 68

Reports and Notifications ................................................................................................ 80
Notice of Accreditation of CB ................................................................................... 83
Notice of Accredited CB Noncompliance in Issuing Food or Facility Certification .... 90
Notice of Denial of Accreditation of CB .................................................................... 97
Notice of Significant Change.................................................................................. 102
Notice of Expansion of Scope of Accredited CB .................................................... 107
Notice of Intent to Relinquish or Not to Renew ...................................................... 112
Notice of Withdrawal, Suspension, or Reduction in Scope of Accreditation of CB. 121
Reinstatement of a Certification Body in Whole or in Part ..................................... 127

November 2018

Abbreviations
AB
CB
CFSAN
FDA
OAA
ORA

Accreditation Body
Certification Body
Center for Food Safety and Applied Nutrition
U.S. Food and Drug Administration
Online Account Administration
Office of Regulatory Affairs

Icon Behavior
Standardized icons are used throughout the system. Each icon performs a specific system
function. The icon description and system function is described below:
Icon Description
Magnifying Glass
Pencil

Icon

System Function
View the associated item.
Edit the associated item.
Lists the total number of records associated
with the item. The number within parenthesis
is a clickable link.
• Example, “(3)” indicates that there are three

Numbers within
parenthesis
•

scopes associated with the certification
body. The AB may click the link to view the
three scopes records.
Example, “(1)” indicates that there is one
audit agent associated to the certification
body. The AB may click the link to view a list
of active audit agent(s).

Trash Can

Delete the associated item.

Printer

Print the associated item.

1 Introduction
This document is intended for Accreditation Bodies (ABs) or persons who are authorized to act
on their behalf, who are applying or seeking renewal for recognition in FDA’s Accredited ThirdParty Certification Program. If approved by FDA, ABs may manage their profiles, including the
Certification Bodies (CBs) they have accredited.
This document provides detailed instructions on how an AB can use FDA’s electronic portal for
the following:
•
•
•
•

Submit an application
Manage an AB profile
Add and manage CBs
Communicate with FDA

2 Overview of FDA Portals for Electronic Accredited Third-Party
Certification Program Submissions
FDA Industry Systems (FIS)
FDA Industry Systems (FIS) is an electronic portal which facilitates making submissions to the
FDA; it includes registration, listing, and other notifications. FIS is available 24 hours a day,
seven days a week. It provides general entry to a series of systems which allow electronic
submissions to the FDA.
FDA’s Unified Registration and Listing System (FURLS)
FDA’s Unified Registration and Listing System (FURLS) is a specific component of FIS.
Persons with an FDA account ID and password for the FIS electronic portal can use systems
within the FURLS components to exchange information with the Agency. The FURLS system
described in this document is for the Accredited Third-Party Certification Program.
Adding Attachments
Users of the system may need to provide additional information to the Agency while working in
the portal. Additional documentation can be provided by attaching an electronic file (e.g.,
reports, schematics, or other supporting information).
The electronic Accredited Third-Party Certification Program system supports attachments of
the following document types: 1) .pdf; 2) .png; 3) .jpeg; 4) .gif; 5) .bmp; 6) .jpg; 7) .jpe; 8). jfif; 9)
.tif; 10) .tiff; 11) .doc; 12) .docx; 13) .ppt; 14) .xls; 15) .xlsx; 16) .txt; 17) .pptx; and 18) .rtf. The
maximum file size allowed is 50 MB. Relevant sections of this document will identify
opportunities for adding attachments.
1

Supported Browsers
FURLS may be accessed using Firefox, Chrome, or Internet Explorer. Please visit the
“Systems Requirements” section of the FURLS page for a list of approved browsers and
browser versions. The “Systems Requirements” section can be found by navigating to
https://www.access.fda.gov/.
Obtain an FDA Account through the FDA FIS Electronic Portal
Each person who uses this system needs a personal FDA Account ID and password. To
access the FIS electronic portal, go to https://www.access.fda.gov/oaa/. Click the “Create New
Account” button near the bottom of the page, in the New User section. Then follow the
instructions for obtaining an FDA Account ID and password below. Once the account has been
created, you will be able to log into the “Online Account Administration” (OAA) system.

3 Create an FDA Online Account
Create an online account by clicking on the “Create New Account” button on the “FDA Industry
Systems” (FIS) Online Account Administration (OAA) page (Figure 3.1). You will be directed to
the “Create New Account” page.
Figure 3.1 – FDA OAA Page

•
•
•

System Status – Directs users to the “FDA Industry Systems – System Status” page
which displays the current system status, system status explanations, and the system
status history.
See Instructions and See Tutorials – Directs users to the “FDA Industry Systems
User Guide: Account Management” page which includes general information (e.g.,
Step-by-Step help guides and account management Q&A.
Help Desk – Directs users to the “FDA Industry Systems” page where FDA Help Desk
contact information can be found.

Note: The following buttons are displayed on the “OAA” landing page and direct you to
informational pages on fda.gov as indicated. You will not be required to select any of these
buttons in order to complete your application, but are there for your reference if needed (Figure
3.2):
Figure 3.2 – Additional Buttons

Click the “Create New Account” button:
The system displays the “Create New Account” page (Figure 3.3). You will see “Step 1: Select
Application(s) for Account Creation.” Two radio buttons are displayed, “Yes” and “No.” Note
that “No” is selected by default.
Note: Leave the default value of the selected radio button as “No.” The workflow that is
created by selecting “Yes” directs you to a program that is not part of the scope of this user
guide.

Figure 3.3 – Create New Account - Step 1: Select Application(s) for Account Creation

The system displays the various programs available in OAA.
Select the “Third-Party Program - Accreditation Body" checkbox under the “FSMA Program(s)”
section (Figure 3.4) and continue to the next step.
Figure 3.4 – Create New Account - FSMA Program(s)

The next section is “Step 2: Enter Your Account Information” where AB applicants provide their
Point of Contact information, unique account information, and the account holders physical
address (Figure 3.5).
Figure 3.5 – Create New Account – Step 2: Enter Your Account Information

The following navigation buttons can be found throughout the system:
• Previous – Returns to the previous screen
• Clear – Clears all input entered on the specific page/section
• Continue – Proceeds to the next screen/step in the account creation process
Note: All application fields are required, unless indicated as “Optional.” Non-required fields will
be marked as “Optional.”
5

Enter “N/A” in any required field that does not apply to you.
Complete each of the data fields in Step 2A (Figure 3.6).
Figure 3.6 – Step 2A: Point of Contact Information

The data fields in the “Step 2A: Point of Contact Information” section include:
•
•
•
•
•
•
•

•
•
•

First Name – The first name of the Point of Contact.
Middle Initial (Optional field) – The first letter of the Point of Contact’s middle name.
Last Name/Surname – The last name of the Point of Contact.
Job Title – The job title of the Point of Contact.
Company Name – The name of the company the Point of Contact represents.
Web Address (Optional field) – The URL of the company.
Phone Number (Country/Area/Phone Number/Extension) – The telephone number
of the Point of Contact.
o “Country” is the country code.
o “Area” is the three-digit area code.
o “Phone Number” is the seven-digit phone number.
o “Extension” is the local phone extension to dial the Point of Contact, if applicable.
Fax Number (Country/Area/Fax Number) – The fax number of the Point of Contact.
“Country” is the country code. “Area” is the three-digit area code. “Fax Number” is the
seven-digit phone number.
E-mail Address – The e-mail address of the Point of Contact.
Confirm E-mail Address – The re-entry of the Point of Contact’s e-mail address (the
entry must match the “E-mail Address” field).

Once you have completed Step 2A, proceed to “Step 2B: Account Information” (Figure 3.7).
Figure 3.7 – Step 2B: Account Information

The data fields in Section 2B - Account Information include:
•
•
•
•
•

Password – Use this field to create the password for the AB’s account. Use this
password each time you log into the system.
Confirm Password – Re-enter the password in the “Password” field. The entry must
match the “Password” field.
Secret Question 1 – This is the first secret question used to protect the account. Select
a question from the drop-down list.
Secret Answer 1 – This is the answer to the first secret question. Enter your response
to the question selected in “Secret Question 1.”
Secret Question 2 – The second secret question used to protect the account. Select a
question from the drop-down list.
8

•
•
•

Secret Answer 2 – This is the answer to the second secret question. Enter your
response to the question selected in “Secret Question 2.”
Secret Question 3 – This is the third secret question used to protect the account.
Select a question from the drop-down list.
Secret Answer 3 – This is the answer to the third secret question. Enter your response
to the question selected in “Secret Question 3.”

Once you have completed Step 2B, proceed to “Step 2C: Physical Address (Business) of
Account Holder” (Figure 3.8).
Figure 3.8 – Step 2C: Physical Address (Business) of Account Holder

The data fields in “Step 2C: Physical Address (Business) of Account Holder” include:
•
•
•
•
•
•
•
•

Country/Area – The country/area where the business is located.
Select a country/area from the drop-down list.
Address Line 1 – The address where the business is physically located. This includes
the number, street, quadrant, etc.
Address Line 2 (Optional field) – The field to enter additional information about the
physical location of the company. This may include a suite or apartment number, if
applicable.
City – The city where the business is physically located.
State/Province/Territory – The state/province/territory where the business is physically
located.
Zip Code (Postal Code) – The zip code (domestic) or postal code (foreign) where the
business is physically located.
Unique Facility Identifier (Optional field) – This may be a DUNS number or FDA
Establishment Identifier (FEI).
Do you have preferred mailing address other than the physical address
mentioned above? – Select the “Yes” or “No” radio buttons to answer this question.
o If “No” - Select the checkbox for “I understand” at the bottom of the page (Figure
3.10). The physical address will be used as the mailing address.
o If “Yes” - “Section 2D: Preferred Mailing Address” displays. Section 2D must be
completed to proceed to the next step (Figure 3.9). Next, select the checkbox for
“I understand” at the bottom of the page (Figure 3.10). The address entered in
Section 2D will be used as the mailing address.

Figure 3.9 – Step 2D: Preferred Mailing Address

'’
Figure 3.10 – Checkbox

“Continue” after you have entered the required account information (Figure 3.10).
The “Account Review” page will be displayed (Figure 3.11). Review the data entered to ensure
it is correct.
Click “Submit” to complete the process. Click “Modify” to edit the profile information in the
previous page.
11

Figure 3.11 – Account Review Page

When you click “Submit,” the system displays a message that the account was created
successfully. The message displays your Account ID (Figure 3.12). You will need to retain your
account ID and password to login to the system in the future.
12

Figure 3.12 – Successful Account Creation Message Page

Once you create an account, you will receive an e-mail notification to the e-mail address
entered in “Account Information” page (Figure 3.13).
Figure 3.13 – Account Creation Confirmation e-mail

4 Submit an Application for Recognition as an Accreditation
Body (AB)
As an AB, log into the FDA “OAA” page (https://www.access.fda.gov/oaa/), which is the
same page used to begin the process of creating a new OAA account (Figure 4.1).
Figure 4.1 – OAA Login

Once the AB has logged into the FDA “OAA” page, the FURLS “Account Management”
homepage (Figure 4.2) is displayed. Go to the “FSMA Program(s)” section and select the
hyperlink for "Third-Party Program—Accreditation Body.”
Figure 4.2 – OAA - FURLS Account Management Home Page

Select the hyperlink for “Third-Party Program—Accreditation Body” to navigate to the “AB
Home” page; the banner for this page is titled “Accreditation Body (AB) Program” (Figure 4.3).

Note that each screen in the AB electronic submission process has the banner “Accreditation
Body (AB) Program.” The “FURLS Home” link on the right side of the banner will take you
back to the FURLS “Home” page, where you may log out.
Figure 4.3 – AB “Home” Page

5 Apply for Recognition and Implementing FDA Regulations
Select the “Apply for Recognition” link in the left navigation menu (Figure 5.1) to create a
new application for recognition as an AB. The “Applicant Information” page (Figure 5.2) will
open.
"AB Home" will take you to the Main Menu on the “AB Home” page.
Figure 5.1 – Apply for Recognition

Verify that the information listed in “Applicant Information” tab (Figure 5.2) is correct and click
the “Next” button or click the “Revocation” tab directly. This page displays read-only
information from your user profile.
Figure 5.2 – Applicant Information

Note: You will see the following buttons while navigating the tabs during the course of the
application process (Figure 5.3):
•
•
•

Previous – Directs you to the previous page; this saves any user input from other
pages, only during the current session.
Save – Saves any input from the current page (from session to session), even if the
application has not been completed.
Next – Directs you to the next page; will save any user input from other pages only
during the current session.

Figure 5.3 – Previous, Save and Next Buttons

The default value stated on the “Revocation” tab is “Not Applicable” (Figure 5.4).
Figure 5.4 – Revocation

Proceed to the next tab by clicking the “Next” button or click directly on the “Scope” tab
(Figure 5.5).
The “Scope” tab lists the 21 CFR regulations for which you may apply. The 21 CFR regulations
will henceforth be referred to as scopes.
Figure 5.5 – Scope

This page contains a list of all possible scopes. You must select at least one scope from the
“List of Original Source Scopes” to complete your application.
To select a scope, left click the text; the text will appear highlighted. The following buttons are
used to add or remove selected scopes:
•

“Add”– Moves the selected scope to the “List of Selected Scopes.”

•

“Add All”– Selects and moves all scopes to the “List of Selected Scopes.”
20

•

“Remove”– Removes one selected scope from the “List of Selected Scopes.”

•

“Remove All” – Removes all scopes from the “List of Selected Scopes.”

Use the scroll bar at the bottom of the “List of Original Source Scopes” to see full titles of
scopes.
A keyword(s) search can be performed in either the “List of Original Source Scopes” or “List of
Selected Scopes.
Type the keyword(s) in the Search bar (Figure 5.6). The search results can be added or
deleted from the respective lists.
Clear the “Search” box by using the “Backspace” key or highlighting the text and pressing the
“Delete” key.
Figure 5.6 – Searching by Scope

Click the “Save” button when all applicable scopes have been selected (Figure 5.7).
Figure 5.7 – Save and Next
21

Click the “Next” button to proceed to the “Eligibility” page. You may also click the “Eligibility”
tab directly. The “Eligibility” page allows you to answer questions and attach files for the
following standards:
•
•
•
•
•
•
•
•
•

Legal Authority
Responsibility
Capacity
Competency
Monitoring
Conflict of Interest
Quality Assurance
Records
Accreditation Program

The standards are listed on the left-hand side of the page. The first standard, “Legal Authority,”
is expanded by default upon navigating to the page (Figure 5.8).

Figure 5.8 – Eligibility Default View

Each standard tab has a definition and associated questions. Click the standard drop-down to
display the question links.
Select the question link to display the “Question and Response” text box (Figure 5.9).
Note: You must answer all the questions to complete the application process.
Figure 5.9 – Completing Eligibility Standards Questions

Attachments may be uploaded with each response. Attachments must be a document type
supported by the system.
The system supports the following document types: .pdf; .png; .jpeg; .gif; .bmp; .jpg; .jpe;. jfif;
.tif; .tiff; .doc; .docx; .ppt; .xls; .xlsx; .txt; .pptx; or .rtf.
The maximum file size allowed is 50 MB.
Click the “Attachments” button to open the attachment screen (Figure 5.10).
Figure 5.10 – Opening Attachments Window

The system will display a pop-up window (Figure 5.11).

Click the “Browse” button in the “Attachments” window to select a file.
The “Upload” button will become enabled after a file has been chosen as an attachment.
Click the “Upload” button to complete upload (Figure 5.11).
Figure 5.11 – Attachments Window

Once the upload is complete, a confirmation message with the file name will display in the
“Attachments” window (Figure 5.12).
To remove the attachment, click the trash/delete icon in the “Action” column.
Figure 5.12 – Attachments to Eligibility Questions

Use the “Close” button to close the “Attachments” window after the file has been uploaded.
You must answer all of the Eligibility questions in order to complete the application. Important:
Click “Save” upon completion.
Proceed to the next tab by clicking “Next” button or click directly on the “Attachments” tab.
To upload documents to your application, use the “Attachments” tab. This tab is optional.
Follow steps 1 - 4 in the instructions to upload attachments (Figure 5.13).
27

Figure 5.13 – Attachments

Select the type of attachment from the list (Figure 5.14).
Figure 5.14 - Type of Attachment

A text box labeled “Additional Description” will display if you select “Other” from the list (Figure
5.15).
Enter a detailed description of the document type in the “Additional Description” field
(maximum 45 characters).
Figure 5.15 – Other Attachments

Once you have selected a Type of Attachment, the “Browse” button becomes enabled. Click
the “Browse” button to search for and select the desired file for upload.
The browsing window will close once a file is selected. The “Upload” and “Cancel” buttons will
be enabled once the browsing window closes (Figure 5.16).

Figure 5.16 – Upload and Cancel Buttons

Click “Upload” to attach the file. Click “Cancel” to remove the file from the menu.

Confirmation of successful upload will be displayed at the top of the page upon completion
(Figure 5.17).
Figure 5.17 – Successful Upload Message

After the additional files have been uploaded, click the “Save” and “Next” buttons or, click the
“Summary” tab.
The system will display the “Summary” page (Figure 5.18). Review the data for accuracy.

Figure 5.18 – Summary Page

After reviewing the “Summary” page click the “Save” and then the “Next” button(s). The system
validates all the information you entered. If an error is found, the system will post a relevant
error message.
To be able to submit the application, correct any issues that were found and flagged by the
system. The system marks errors with a red flag icon (Figure 5.19). Any eligibility area that
contains an error will show a red flag in the drop-down menu.
Click the flag(s) to expand the drop-down menu to see which specific questions have an error.
Figure 5.19 – Submission Errors

If there are no errors, the system will display the “e-Signature” page (Figure 5.20).
Note: The “e-Signature” tab does not become accessible until all errors indicated on the
Summary page have been corrected and saved.
Follow the directions provided on the “e-Signature” page.
Click the check mark to indicate you certify the information in the submission is true and
accurate and, that you are authorized to submit the information to the FDA.
33

The following data fields are present:
•
•

Name of Submitter - The first and last name of the application submitter.
Title of Submitter - The title of the application submitter.

Fill in the required data fields, and click the “Submit” button.
Figures 5.20 – e-Signature Page

The system will post a confirmation message on the page (Figure 5.21).
Figure 5.21 – Confirmation Message

Note: To check the status of the application please see the “Dashboard” page. To reach this
page from the “Confirmation” page, click on the “Dashboard” breadcrumb at the top of the
screen. To navigate to the Dashboard from the AB “Home” page, select the “View/Edit my
application for recognition” option from the left-hand navigation menu.
After the application has been submitted, it is assigned an Application Number and the
Application Status will be displayed as “Pending” on the Dashboard (Figure 5.22).

Figure 5.22 – Application “Pending” Status

When FDA receives the completed application, the status on the dashboard will change to
“Submitted” (Figure 5.23).
Figure 5.23 – Application “Submitted” Status

6 Application Returned for Further Action
The FDA may return an application if it determines that additional information is needed. The
FDA will provide guidance to the applicant on what information is needed to address any
concerns.
The applicant must submit the requested information before the FDA will continue the
application review process.
When the application has been returned with additional information, the application status will
display as “In-Process.”
The Eligibility criteria in question will display as “Returned for Action.”
The status of all other Eligibility criteria will display as “Under Review” (Figure 6.1).
Figure 6.1 – Application “In-Process” Status

To address the information request from FDA, click the “Edit” (pencil) icon in the “Action”
column on the “Application Information” page (Figure 6.2).
Figure 6.2 – Edit icon

The system will open the “Eligibility” page (Figure 6.3). Eligibility criteria that display red flags
indicate a response is needed. Click on the standard drop-down to expand the section.
Click on the questions marked with red flags to provide your response. Questions may have
one or more requests (Figure 6.3).
Go directly to the red-flagged standard(s) to provide the required answers, information and/or
attachments.

Figure 6.3 – Eligibility Criteria Page with Red Flags

After you have addressed any outstanding items, the red flag will change to a green
checkmark (Figure 6.4).
Figure 6.4 – Eligibility Criteria Page with Green Checkmarks

Once you have addressed all outstanding items, go to the “Summary” page by clicking the
40

“Save” and “Next” buttons from the “Eligibility” page, or clicking the “Summary” tab directly.
Verify the information and select the checkbox next to the applicable standard being
resubmitted (Figure 6.5). Click the “Save” and “Next” buttons.
Figure 6.5 – Summary Page

The system validates all the information and if no errors are found, the “e-Signature” page is
displayed (Figure 6.6). If an error is found, the system will post an error message.
After you correct the error, re-submit the application.
Follow the directions provided on the “e-Signature” page.
Click the check mark to indicate that you certify that the information in the submission is true
and accurate and that you are authorized to submit the information to the FDA.
The following data fields are present:
•
•

Name of Submitter – The first and last name of the application submitter.
Title of Submitter – The title of the application submitter.

Fill in the required data fields and click the “Submit” button.

Figure 6.6 – e-Signature Page

The system will post a confirmation message on the page (Figure 6.7).
Figure 6.7 – Confirmation Message

After the application has been re-submitted, the “Application Status” will become “In-Process.”
Figure 6.8 – Application “In-Process” Status

7 Reconsideration Request
You may submit a “Reconsideration Request” if any scopes have been denied. Navigate to the
“Dashboard” to check the status of your application.
The “Application Status” field will display “Denied” if an application is not approved (Figure
7.1).
Figure 7.1 – Application “Denied” Status

You can access the reconsideration request from the “AB Home” screen. Click on the
“Reconsideration Request” option on the left navigation menu (Figure 7.2).

Figure 7.2 – AB Home – Reconsideration Request Menu Option

Select the link to “Reconsideration Request”; the system will open the “Reconsideration” page.
If you choose “Yes” (Figure 7.3), then the application will be prefilled with your previouslyentered profile information; however, if you need to edit any information, you will need to do so
in OAA.
Figure 7.3 – Reconsideration Page (“Yes”)

If you choose “No” (Figure 7.4), the applicant information will not be prefilled and all application
information must be entered.
Figure 7.4 – Reconsideration Page (“No”)

The “Next” button will appear at the bottom of the screen once a radio button is selected.
Click the “Next” button to go to the next page, “Applicant Information” (Figure 7.5). The
information on this page is read-only.
The following navigation buttons are available:
• Previous – Directs to the previous page.
• Save – Saves any user input from the current page from session to session even if the
application has not been completed.
• Next – Directs to the next page; will save any user input from other pages only during
the current session.

Figure 7.5 – Applicant Information Page

Click the “Next” button to go to the “Revocation” page (Figure 7.6).
The system will check for a record of previous FDA revocation of this AB. If none are found
“Not Applicable” is displayed.

Figure 7.6 – Revocation Page

Click the “Next” button to open the “Scope” page (Figure 7.7). The “List of Original Scopes”
shows all the scopes which were not approved in the original application.
Select the scopes you are applying for reconsideration.
Select at one (or more) scopes from the “List of Original Source Scopes” to complete your
application.
To select a scope, left-click on the text. The text will appear highlighted. The following buttons
may be used to add or remove selected scopes:
•

“Add” Button – Moves the selected scope to the “List of Selected Scopes.”

•

“Add All” Button – Selects and moves all scopes to the “List of Selected Scopes.”

•
•

“Remove” Button – Removes one selected scope from the “List of Selected
Scopes.”
“Remove All” Button – Removes all scopes from the “List of Selected Scopes.”

Use the scroll bar at the bottom of the “List of Original Source Scopes” to see the full titles of
scopes.
50

A keyword(s) search can be performed in either the “List of Original Source Scopes” or “List of
Selected Scopes. Type the keyword(s) in the Search bar (as was shown in Figure 5.7). The
search results can be added or deleted from the respective lists.
Clear the Search box by using the “Backspace” key or highlighting the text and pressing the
“Delete” key.
Note: Even if you select “Yes” on the “Reconsideration” page the system will not prefill the
scopes.
Figure 7.7 – Scope Page

Click the “Next” button and go to the “Eligibility Criteria” page (Figure 7.8). This page will be
prefilled with the information you provided in the initial application if you selected “yes” on the
initial Reconsideration page (See Figure 7.3).
Update the page, as needed, to support your reconsideration request.
Click the “Save” button to save any changes.
Figure 7.8 – Eligibility Criteria Page

Click the “Next” button to go to the “Attachments” page (Figure 7.9).
Upload files in the “Attachments” page by following the four-step process outlined on the page.
The system displays uploaded files in the table at the bottom of the page.
Figure 7.9 – Attachments Page

Note: The “Attachments” page is optional. You may choose to click the “Save” button on the
“Eligibility Criteria” page, and then select the “Summary” tab, which will open the “Summary”
page (Figure 7.10) to bypass the “Attachments” page.
Within the “Summary” page, review the application information and make any edits, if needed.
53

Figure 7.10 – Summary Page

After completing the “Summary” page, click the “Next” button to move to the “e-Signature”
page.
54

The system will validate that all required fields have been completed. If no errors are found,
the system opens the “e-Signature” page (Figure 7.11). If an error is found, the system will
post an error message.
To be able to submit the application, correct any issues that were found.
Follow the directions provided on the “e-Signature” page.
Click the check mark to certify that the information in the submission is true and accurate and,
that you are authorized to submit the information to the FDA.
The following data fields are present:
•
•

Name of Submitter – The first and last name of the application submitter.
Title of Submitter – The title of the application submitter.

Fill in the required data fields and click the “Submit” button.
Figure 7.11 – e-Signature Page

Once your reconsideration request has been transmitted, the system will display a confirmation
55

message on the page (Figure 7.12).
Figure 7.12 – Confirmation Message

Once FDA receives the reconsideration application transmission, the application status will
display as “Reconsideration - Submitted” (Figure 7.13).
Figure 7.13 – Application “Submitted” Status

If FDA approves the reconsideration application for any scopes, the application status will
display as “Reconsideration - Recognized” (Figure 7.14).
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Figure 7.14 – Application “Recognized” Status

8 Add or Manage Third-Party Certification Bodies (CBs)
Once recognized by the FDA, you will need to supply information related to the Certification
Bodies (CB) you accredit under the Accredited Third-Party Certification program.
Select the “Add or Manage my Third-Party CBs” option from the left navigation menu on the
“AB Home” page (Figure 8.1) to add a new CB, or modify information for an existing CB.
Figure 8.1 – AB Homepage with Add or Manage My Third-Party CBs Menu Option

Add Accredited Third-Party CB
Click on the “Add or manage my Third-party CBs” button. The system will display the “Add or
Manage my Third-Party CBs” page (Figure 8.1.1).
Click the “Add CB” button to add a new CB.
Figure 8.1.1 – Add or Manage my Third-Party CBs Page

The system will display the “Add Accredited Third-Party CB” page (Figure 8.1.2). Enter the email address of the new CB and click the “Search” button. If the system finds the mail address
in the database it populates the relevant fields with the CB’s information.
If the search does not find an existing CB, enter the required information.
Note: The CB data fields will not become enabled until you enter an e-mail address and click
the “Search CB” button.

Figure 8.1.2 – Add Accredited Third-Party CB Page

The data fields for completion in the “Add Accredited Third-Party CB” page are:
•
•
•
•

•
•
•
•

•

•
•

E-mail Address – The e-mail address for the CB you want to add.
Third-Party Certification Body Name – The name of the CB that you want to add.
Country – The country where the CB is physically located.
Address 1 – The address where the CB is physically located (includes the number,
street, quadrant, etc.).
Address 2 (Optional field) – The additional information about the physical location of
the company (may include a suite or apartment number, if applicable).
City – The city where the CB is physically located.
State/Province/Territory – The state/province/territory of the CB.
Zip Code (Postal Code) – The zip code or postal code of the CB.
Contact Name
o First Name – The first name of the Point of Contact.
o MI (Optional field) – The first letter of the Point of Contact’s middle name.
o Last Name – The last name of the Point of Contact.
Phone Number
o Country – The country code of the Point of Contact.
o Area – The area code of the Point of Contact.
o Phone Number – The phone number of the Point of Contact.
o Extension – The extension number of the Point of Contact.
Fax Number
o Country (Optional field) – The country code for the fax number.
o Area (Optional field) – The area code for the fax number.
o Fax Number (Optional field) – The fax number for the Point of Contact.
Web Address (Optional field) – The URL of the CB.
Officer(s) – The Officer(s) of the CB.

The “Add/Manage Scope(s)” button becomes enabled once you have entered all the required
data. Click the “Add/Manage Scope(s)” button to associate scopes to the CB. The system will
open the “Add/Manage Scope(s)” display in a new window (Figure 8.1.3).

Figure 8.1.3 – Add/Manage Scope(s) Window

The system displays your recognized scope(s). Select the scopes you will associate to the CB
by checking the box in the “Select” field. You must select at least one scope.
The “Accreditation Date” and “Expiration Date” fields are enabled once the scope is selected.
Enter the dates for each selected scope in “YYYY-MM-DD” format.
Click the “Save” button when all the data is entered. The system will close the “Add/Manage
Scope(s)” window and returns to the main page. The newly added scopes will be displayed in
the “Scopes of Accredited Third-Party Certification Body” table (Figure 8.1.4).
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Figure 8.1.4 – Scopes of Accredited Third-Party Certification Body Page

Once a scope has been added the “Will the CB use Audit Agents to conduct food safety
audits?” question becomes enabled. Select “Yes” or “No.”
If you select “No” the system displays the “Audit Agent(s)” table and pre-populates it with the
CB’s name.
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If you select “Yes” the “Add Audit Agent(s)” window displays over the page. Enter an e-mail
address and click the “Search Agent” button (Figure 8.1.5).
If the search finds an existing e-mail address in the system, then the Audit Agent’s name will
be displayed. If the search does not find a match a text field will be displayed.
Enter the Audit Agent’s name in the text field and click the “Add Agent” button (Figure 8.1.6).
The agent is added to the “Audit Agent(s)” table (Figure 8.1.7). Once you have provided the
Audit Agent information, click the “Save” button to return to the “Add Accredited Third-Party
CB” page.
Figure 8.1.5. – Add Audit Agent(s) Window Part 1

Figure 8.1.6 – Add Audit Agent(s) Window Part 2

Figure 8.1.7 – Add Audit Agent(s) Window Part 3

After saving the information, an “Audit Agent(s)” section will appear on the “Add Accredited
Third-Party CB” page (Figure 8.1.8). A list of saved Audit Agent(s) will be displayed in the Audit
Agent(s) table.
Figure 8.1.8 – Audit Agent(s) Table

After entering all mandatory information, click the “Save” button on the “Add Accredited ThirdParty CB” page. If there are no errors, the system will display a confirmation message over the
page (Figure 8.1.9).
Figure 8.1.9 – Confirmation Message

Click the “OK” button to close the confirmation message. The system will navigate to the “Add
or Manage my Third-Party CBs” page. The system will display the newly added CB in the table
(Figure 8.1.10).
Note: A CB accreditation will not be reported to the FDA until you complete the “Notice of
Accreditation of CB” from the “Reports and Notifications” tab. You will receive a confirmation
message instructing you to complete the notification after you enter the accreditation
information (Figure 8.1.10). Section 9.1 of this user guide provides instructions on how to
complete and submit the notification.

Figure 8.1.10 – Add or Manage my Third-Party CBs Page

Update Accredited Third-Party CB
Update an Accredited Third-Party CB by clicking the pencil icon in the “Action” column on the
“Add or Manage my Third-Party CBs” page (Figure 8.2.1).

Figure 8.2.1 – Add or Manage my Third-Party CBs Page

Figure 8.2.2 – Update Accredited Third-Party CB Page

Update the CB(s) status by clicking the “Update Status” button. The system displays an
“Update Status” window (Figure 8.2.3).
Figure 8.2.3 – Update Status Window

The options available in the “Status” drop-down field are dependent on the current status of the
CB (Figure 8.2.4). For example:
• If the CB is “Accredited,” then the status can be updated to “Suspended” or
“Withdrawn.”
• If the CB is “Suspended,” then the status can be updated to “Accredited” or
“Withdrawn.”
• If the CB is “Reinstated,” then the status can be updated to “Withdrawn” or
“Suspended.”
• If the CB is “Withdrawn,” then the status cannot be updated until it has first been
“Reinstated” via the “Reinstatement of a Certification Body in Whole or in Part”
notification (see Section 9.8 for details).
An AB cannot update CB statuses that were updated by the FDA.
The following data fields are present:
• Status - The drop-down options are “Suspended” or “Withdrawn.”
• Effective Date of Status Change – The effective date of the status change.
• Reason for change - The reason for status change.
Fill in the required data fields, and click the “Save” button.
Figure 8.2.4 – Update Status window selections

The system closes the “Update Status” window and returns to the “Update Accredited ThirdParty CB” page.
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The updated status displays in the “Status” field on the central portion of the page (Figure
8.2.5).
Figure 8.2.5 – Update Accredited Third Party CB Page with updated CB Status

Add and/or update the CB’s scopes by clicking the “Add/Update Scope” button from the

“Update Accredited Third-Party CB” page. The system displays the “Add/Update Scope” page
(Figure 8.2.6).
Figure 8.2.6 – Add/Update Scope Page Part 1

Only scopes that have an Accreditation and Expiration date can be selected (Figure 8.2.7).

Figure 8.2.7 – Add/Update Scope Page Part 2

Select the checkbox for the scope that you would like to update on the “Add/Update Scope”
page. The system displays the “Update Scope” window (Figure 8.2.8).
When updating scopes, the options available in the “Status” drop-down field are dependent on
the current status of the specific scope (Figure 8.2.8). For example:
• If the scope is “Accredited,” then the status can be updated to “Suspended” or
“Withdrawn.”
• If the scope is “Suspended,” then the status can be updated to “Accredited” or
“Withdrawn.”
• If the scope is “Withdrawn,” then the status can be updated to “Accredited.”
• If the scope is “Reinstated,” then the status can be updated to “Suspended” or
“Withdrawn.”
An AB cannot update scopes that are “Failed to Renew. “An AB cannot update CB scopes that
were changed by FDA. An AB cannot add a scope to a CB if that particular scope is in the
“Suspended” status.
The following data fields are present:
• Status – The drop-down menu option of “Reinstated,” “Suspended,” or “Withdrawn.”
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•

Expiration Date – The expiration date of the added or updated scope.

Note: Do not select a status from the “Status” menu when only extending the Expiration Date.
Figure 8.2.8 – Update Scope Window

If you select a status from the drop-down list the system will display the following data fields
(Figure 8.2.9):
•
•
•
•

Status – The drop-down menu option of “Suspended” or “Withdrawn.”
Expiration Date - The updated expiration date of the scope.
Reason for Change - The reason the scope expiration date was changed.
Effective Date – The date the status change became effective.

Note: The scope effective date cannot precede the start date, or exceed the expiration date of
the CB accreditation.

Figure 8.2.9 – Update Scope Window – Suspended Status

Fill in the required data fields, and click the “Save” button from the “Update Scope” window; the
system will close the window. Then click the “Save” button from the “Update Scope” page.

Note: The changes will not be saved if the “Save” button is not clicked in both places.
View the scope update(s) in the “Add/Update Scope” page (Figure 8.2.10).
Figure 8.2.10 - Updated Scope

To add a scope, return to the “Update Accredited Third-Party CB” page. Click the “Add/Update
Scope” button (Figure 8.2.2).

Select a scope that does not have a value in the “Status” column (See Figure 8.2.6). The
system displays an “Add Scope” window (Figure 8.2.11).
Figure 8.2.11 – Add Scope Window

Fill in the required data fields:
•
•
•

Accreditation Date – The start date for the scope accreditation.
Expiration Date – The expiration date for the scope accreditation (the scope expiration
date cannot exceed the accreditation expiration date).
Reason for Change – The reason the scope was added to the accreditation.

Click the “Save” button. The system closes the “Add Scope” window and returns to the main
“Add/Update Scope” page.
Click “Save.”

9 Reports and Notifications
Several options exist within the Reports and Notifications directory.
To access the available functionality, click the “Reports and Notifications” option from the left
navigation menu on the “AB Home” page (Figure 9.1).
Figure 9.1 – AB Home Page with Reports and Notifications Menu Option

The system will display the “Reports and Notifications” page (Figure 9.2) with the following
reports and notifications available:
•
•
•
•
•
•
•
•

Notice of Accreditation of CB – Generates a notice to FDA when the AB accredits a
CB.
Notice of Accredited CB Noncompliance in Issuing Food or Facility Certification –
Generates a notice to FDA when the CB has a noncompliance with the requirements of
21 CFR Part 1, Subpart M.
Notice of Withdrawal, Suspension, or Reduction in Scope of Accreditation of CB –
Generates a notice to FDA when the AB takes the following actions with CB;
withdrawal, suspension, or reduction in scope.
Notice of Denial of Accreditation of CB – Generates a notice to FDA when the AB
denies accreditation to a CB.
Notice of Significant Change – Generates a notice to FDA when the AB makes any
significant change which would affect the way it complies with the requirements of 21
CFR Part 1, Subpart M.
Notice of Intent to Relinquish or Not to Renew Recognition – Generates a notice to
FDA when the AB intends to relinquish recognition or does not plan to renew
recognition.
Notice of Expansion of Scope of Accredited CB – Generates a notice to FDA when
the AB issues an expansion of the CBs accreditation.
Reinstatement of a Certification Body in Whole or in Part – Generates a notice to
FDA when the AB reinstates an accreditation to the CB (the notification is only available
if an AB-CB relationship is suspended - or if scopes within an AB-CB relationship have
been suspended).

Figure 9.2 – Reports and Notifications Page

Notice of Accreditation of CB
To add an accredited CB to your account, submit a “Notice of Accreditation of CB.”
Select “Notice of Accreditation of CB” from the “Reports and Notifications” page. The system
displays the “Notice of Accreditation of CB” page (Figure 9.1.1).
Select the CB from the “Certification Body” drop-down to notify the FDA of their accreditation.
Figure 9.1.1 – Notice of Accreditation of CB Page

Select a CB from the “Certification Body” drop-down menu. The drop-down menu will display
CB names that have been added in the “Add or manage Third party CBs” menu. The dropdown menu will not display CBs that were included in a previous notification.
Note: The “Certification Body” drop-down list will not appear if there are no CB accounts
pending notification, and the system will display a message to that effect.
Upon selecting a CB from the drop-down menu, the system expands the page to display all the
CB’s information, including accredited scopes (Figure 9.1.2).
Click “Add” to navigate to the “Notice of Accreditation of CB” page. You will see a confirmation
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message at the top of the page that the selected CB was added to the Notice of Accreditation
(Figure 9.1.3).
Select additional CBs from the drop-down menu to add multiple CBs to the same Notice of
Accreditation. Once you have added all applicable CBs click “Next.”
Figure 9.1.2 – Notice of Accreditation of CB Page with CB and Scope Information

The system then displays the next page of instructional text (Figure 9.1.3).
Figure 9.1.3 –Notice of Accreditation of CB Before Submission

Click the “Next” button and the system will display a pop-up window containing the
confirmation message (Figure 9.1.4).
To cancel the action, click the “Cancel” button and return to the “Notice of Accreditation of CB”
page or, proceed with the notice by clicking the “OK” button.

Figure 9.1.4 – Confirmation Message

Once you have clicked the “OK” button to confirm the addition of the CB to the Notice of
Accreditation, the system will display the “e-Signature” page (Figure 9.1.5).
Follow the directions provided on the “e-Signature” page.
Click the check mark to indicate you certify that the information in the submission is true and
accurate and that you are authorized to submit the information to the FDA.
The following data fields are present:
•
•

Name of Submitter – The first and last name of the application submitter.
Title of Submitter – The title of the application submitter.

Fill in the required data fields and click the “Submit” button.

Figure 9.1.5 – e-Signature Page

After you click the “Submit” button the system will display the confirmation message that the
notification has been sent to FDA (Figure 9.1.6).
Figure 9.1.6 – Confirmation Message Page

A confirmation e-mail is sent to the AB Point of Contact indicating that the Notice of
Accreditation was received (Figure 9.1.7).
Please note that all emails will be sent from the [email protected] email address (see example in
Figure 9.1.7 below).
Figure 9.1.7 – E-mail Notification Sent to AB User

Note: The CB must complete the account verification procedure and log into the FURLS
Certification Body Portal to complete the accreditation process.
The CB will receive an email containing the verification code. This verification code must be
entered in the FURLS OAA account screen. Once the verification is complete, the CB must
navigate to the FSMA section of the FURLS landing page and click on the “Third-Party
Program Certification Body” link. The CB will be navigated to the Third-Party Certification Body
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home page. This will complete the accreditation notification to the FDA.
Please visit the FURLS Certification Body User Guide for more information. Section 1.0
provides instructions for creating a CB account and the verification procedures. Section 2.0
provides instructions for logging in to the Third-Party Certification Body home page.

Notice of Accredited CB Noncompliance in Issuing Food or Facility
Certification
Select the “Notice of Accredited CB Noncompliance in Issuing Food or Facility Certification”
link in the “Reports and Notifications” page (Figure 9.2.1).
Figure 9.2.1 – Reports and Notifications Page

The system displays the “Notice of Accredited CB Noncompliance in Issuing Food or Facility
Certification” page (Figure 9.2.2).
Figure 9.2.2 – Notice of Accredited CB Noncompliance in Issuing Food or Facility
Certification Page

Select the CB from the “Certification Body” drop-down menu. The system will display the CB’s
address and accredited scopes (Figure 9.2.3).
Figure 9.2.3 – CB Address and Scope Information

Select the checkbox next to the scope(s) to be submitted with the notice.
To select all of the scopes check the box in the column heading. Provide answers to the
following questions regarding the non-compliance in the text box fields:
•

Under 21 CFR § 1.623(c)(3), describe any failure(s) by the accredited certification
body in complying with the applicable requirements of 21 CFR § 1.653 on the
basis and procedures for issuance of certifications including specifying the
eligible entity (or entities) to which certification was issued and the date(s) of the
audit(s).

•

Provide any additional changes to information that appears above to notice of
accreditation (optional).

The system will display a table of certificates at the bottom of the screen after one or more
scopes are selected (Figure 9.2.4).
Select the certificate(s) to be included in the notice of non-compliance. Select the checkbox in
the “Select one” column (Figure 9.2.4).
To select all of the certificates select the checkbox in the column header.

Figure 9.2.4 – Notice with Selected Scopes and Certification

Click the “Next” button. The system will display the “e-Signature” page (Figure 9.2.5).
Follow the directions provided on the “e-Signature” page.
Click the check mark to indicate that you certify that the information in the submission is true
and accurate and that you are authorized to submit the information to the FDA.
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The following data fields are present:
•
•

Name of Submitter - The first and last name of the application submitter.
Title of Submitter - The title of the application submitter.

Fill in the required data fields, and click the “Submit” button.
Figure 9.2.5 – e-Signature Page

After you click the “Submit” button the system will display the confirmation message (Figure
9.2.6).

Figure 9.2.6 – Confirmation Message

An e-mail is sent to the AB indicating that the notice was received by the FDA (Figure 9.2.7 –
Image depicts the email notification text only).
Figure 9.2.7 – E-mail to AB User

Return to the “Reports and Notifications” page by clicking on the “AB Home” link on the top of
the banner.

Notice of Denial of Accreditation of CB
Select the “Notice of Denial of Accreditation of CB” link in the “Reports and Notifications” page
(Figure 9.3.1).
Figure 9.3.1 – Reports and Notifications Page

The system displays the “Notice of Denial of Accreditation of CB” page (Figure 9.3.2).
Figure 9.3.2 – Notice of Denial of Accreditation of CB Page

Complete the following data fields:
•
•

•

•
•
•

Certification Body – The name of the CB that the AB would like to add to the notice of
denial of accreditation.
Contact Information
o Country – The country where the CB is physically located.
o Address 1 – The street address where the CB is physically located.
o Address 2 (Optional) – Use this field to enter additional information about the
physical location of the company (this may include a suite or apartment number,
if applicable).
o City – The city where the business is physically located.
o State/Province/Territory – The state/province/territory of the CB.
o Zip Code (Postal Code) – The postal code of the CB.
Contact Name
o First name– The first name of the Point of Contact.
o MI (Optional) – The first letter of the Point of Contact’s middle name.
o Last Name– The last name or surname of the Point of Contact.
Phone Number
o Country – The country code of the Point of Contact.
o Area – The area code of the Point of Contact.
o Phone Number – The phone number of the Point of Contact.
o Extension – The extension number of the Point of Contact.
Officer of the Certification Body – The Officer(s) of the CB.
Describe the scope of accreditation requested – The scopes that were denied
accreditation.
Describe any areas within the requested scope of accreditation that were denied
and for each such area describe the basis of denial – The areas of denial and the
reason(s) why the action was taken.

Click the “Next” button.

The system displays the “e-Signature” page (Figure 9.3.3).
Follow the directions provided on the “e-Signature” page.
Click the check mark to certify that the information in the submission is true and accurate and,
that you are authorized to submit the information to the FDA.
The following data fields are present:
•
•

Name of Submitter - The first and last name of the application submitter.
Title of Submitter - The title of the application submitter.

Fill in the required data fields, and click the “Submit” button.
Figure 9.3.3 – e-Signature Page

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After you click the “Submit” button the system will display the confirmation message (Figure
9.3.4).
Figure 9.3.4 – Confirmation Message Page

An e-mail is sent to the AB indicating that the notice was received by the FDA (Figure 9.3.5 –
Image depicts the email notification text only).
Figure 9.3.5 – E-mail Sent to AB User

Return to the “Reports and Notifications” page by clicking on the “AB Home” link on the top of
the banner.

101

Notice of Significant Change
Select the “Notice of Significant Change” link in the “Reports and Notifications” page (Figure
9.4.1).
Figure 9.4.1 – Reports and Notifications Page

102

The system displays the “Notice of Significant Change” page (Figure 9.4.2).
Figure 9.4.2 – Notice of Significant Change Page

103

Complete the following text entry fields:
•

Describe any change(s) that would affect the manner in which you comply with
the applicable requirements of 21 CFR Part 1, Subpart M – The changes observed
with the CB that led to the notice of significant change.

•

Explain the purpose of the change(s) –The purpose of the change (this could be a
withdrawal, suspension, reduction in scope, etc.).

Click the “Next” button.
The system displays the “e-Signature” page (Figure 9.4.3).
Follow the directions provided on the “e-Signature” page.
Click the check mark to indicate that you certify that the information in the submission is true
and accurate and that you are authorized to submit the information to the FDA.
The following data fields are present:
•
•

Name of Submitter – The first and last name of the application submitter.
Title of Submitter – The title of the application submitter.

Fill in the required data fields, and click the “Submit” button.

104

Figure 9.4.3 – e-Signature Page

After you click the “Submit” button the system will display the confirmation message (Figure
9.4.4).
Figure 9.4.4 – Confirmation Message Page

105

An e-mail is sent to the AB indicating that the notice was received by the FDA (Figure 9.4.5 –
Image depicts the email notification text only).
Figure 9.4.5 – E-mail sent to AB User

Return to the “Reports and Notifications” page by clicking on the “AB Home” link on the top of
the banner.

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Notice of Expansion of Scope of Accredited CB
Select the “Notice of Expansion of Scope of Accredited CB” link in the “Reports and
Notifications” page (Figure 9.5.1).
Figure 9.5.1 – Reports and Notifications Page

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The system displays the “Notice of Expansion of Scope of Accredited CB” page (Figure 9.5.2).
Select a name from the “Certification Body” drop-down menu.
Figure 9.5.2 – Notice of Expansion of Scope of Accredited CB Page

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The system displays the CB’s information along with the list of expanded scope(s) (Figure
9.5.3).
Note: The expanded scopes that appear in the Notice of Expansion were those that were
modified in “Add or Manage my Third-Party CBs” page.
Figure 9.5.3 – CB and Scope Information

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Click the “Next” button.
The system displays the “e-Signature” page (Figure 9.5.4).
Follow the directions provided on the “e-Signature” page.
Click on the check mark to indicate that you certify that the information in the submission is
true and accurate and that you are authorized to submit the information to the FDA.
The following data fields are present:
•
•

Name of Submitter - The first and last name of the application submitter.
Title of Submitter - The title of the application submitter.

Fill in the required data fields, and click the “Submit” button.
Figure 9.5.4 – e-Signature Page

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The system will display the confirmation message (Figure 9.5.5).
Figure 9.5.5 – Confirmation Message Page

An e-mail is sent to the AB indicating that the notice was received by the FDA (Figure 9.5.6 –
Image depicts the email notification text only).
Figure 9.5.6 – E-mail sent to AB User

Return to the “Reports and Notifications” page by clicking on the “AB Home” link on the top of
the banner.

111

Notice of Intent to Relinquish or Not to Renew
Select the “Notice of Intent to Relinquish or Not to Renew Recognition” link in the “Reports and
Notifications” page (Figure 9.6.1).
Figure 9.6.1 – Reports and Notifications Page

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The system displays the “Notice of Intent to Relinquish or Not to Renew Recognition” page
(Figure 9.6.2).
Answer the question, “Do you intend to relinquish your recognition prior to its expiration date?”
by selecting one of the two options: “Yes” or “No.”
Figure 9.6.2 – Notice of Intent to Relinquish or Not to Renew Recognition Page

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If you select “Yes,” the system displays the calendar feature and pick (or enter) the “Intended
Date of Relinquishment” (Figure 9.6.3).
Figure 9.6.3 – Intended Date of Relinquishment or Date of Expiration of Recognition

If you select “No” the system will display the AB’s date of expiration of recognition as ReadOnly (Figure 9.6.4).

114

Figure 9.6.4 – Read-Only Date of Intended Date of Relinquishment or Date of Expiration
of Recognition

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Identify who will maintain your records upon relinquishment/non-renewal of your accreditation
(Figure 9.6.5). If you select that the “Accreditation Body” will maintain the records, then the
system will populate the AB’s information.
Figure 9.6.5 – Records Maintained By AB

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If you select “Other”, the system displays the following data fields (Figure 9.6.6) that you must
complete:
• Records Custodian – The name of the AB’s Records Custodian.
• Country – The country where AB’s Records Custodian is physically located.
• Address 1 – The street address where the AB’s Records Custodian is physically
located.
• Address 2 (Optional) – The additional information about the physical location of the
company (this may include a suite or apartment number, if applicable).
• City – The city where the AB’s record custodian is physically located.
• State/Province/Territory – The state/province/territory where the AB’s Records
Custodian is physically located.
• Zip Code (Postal Code) – The postal code where the AB’s Records Custodian is
physically located.
• Telephone (Optional field)
o Country – The country code of the Point of Contact.
o Area – The area code of the Point of Contact.
o Phone Number – The phone number of the Point of Contact.
o Extension – The extension number of the Point of Contact.
• E-mail Address – The e-mail address of the AB’s Records Custodian.

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Figure 9.6.6 – Records Maintained by Other

Upload files to the notice using the “Attachments (Optional)” feature (Figure 9.6.5).
Attachments are not required to submit the notice.
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Click the “Next” button.
The system displays the “e-Signature” page (Figure 9.6.7).
Follow the directions provided on the “e-Signature” page. You must click on the check mark to
certify that the information in the submission is true and accurate and, that you are authorized
to submit the information to the FDA. The following data fields are present:
•
•

Name of Submitter - The first and last name of the application submitter.
Title of Submitter - The title of the application submitter.

Fill in the required data fields, and click the “Submit” button.
Figure 9.6.7 – e-Signature Page

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The system will display the confirmation message (Figure 9.6.8).
Figure 9.6.8 – Confirmation Message Page

An e-mail is sent to the AB indicating that the notice was received by the FDA (Figure 9.6.9 –
Image depicts the email notification text only).
Figure 9.6.9 – E-mail Sent to AB User

You can return to the “Reports and Notifications” page by clicking the “AB Home” link in the top
of the banner.

120

Notice of Withdrawal, Suspension, or Reduction in Scope of
Accreditation of CB
Select the “Notice of Withdrawal, Suspension, or Reduction in Scope of Accreditation of CB”
link in the “Reports and Notifications” page (Figure 9.7.1).
Figure 9.7.1 – Reports and Notifications Page

The system displays the “Notice of Withdrawal, Suspension, or Reduction in Scope of
Accreditation of CB” page. Select the “Certification Body” and the “Type of Action” (Figure
9.7.2).

121

Figure 9.7.2 – Notice of Withdrawal, Suspension, or Reduction in Scope of Accreditation
of CB Page

The following must be completed based on the “Type of Action” selected:
•

•

Withdraw accreditation in whole:
o Provide the “Date of Action” and the “Reason for Action” (Figure 9.7.2). You may
also provide any additional changes to information submitted under the Notice of
Accreditation for the CB (this section is optional).
Suspend accreditation in whole:
o Provide the “Date of Action” and the “Reason for Action” (Figure 9.7.2). You may
also provide any additional changes to information submitted under the Notice of
Accreditation for the CB (this section is optional).
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•

Withdraw, Suspend, or Reduce specific Scope(s):
o The system displays the CB’s scopes (Figure 9.7.3).
o Select a scope and the “Update Scope” box displays (Figure 9.7.4). Select the
“Type of Action” (Suspended, Withdrawn, or Reduction in Scope), and provide
the “Date of Action” (or the “Expiration Date” if “Reduction in Scope” is selected)
and the “Reason for Action.” Click “Save” then click “Next” once selection of all
applicable scopes are completed (optional section - you may also provide any
additional changes to information submitted under the Notice of Accreditation for
the CB.

Figure 9.7.3 – Notice of Withdrawal, Suspension, or Reduction in Scope of Accreditation
of CB Page

123

Figure 9.7.4 – Update Scope

The system displays the “e-Signature” page (Figure 9.7.5).
Follow the directions provided on the “e-Signature” page. You must click on the check mark to
certify that the information in the submission is true and accurate and, that you are authorized
to submit the information to the FDA. The following data fields are present:
•
•

Name of Submitter - The first and last name of the application submitter.
Title of Submitter - The title of the application submitter.

Fill in the required data fields, and click the “Submit” button.

124

Figure 9.7.5 – e-Signature Page

The system will display the confirmation message (Figure 9.7.6).
Figure 9.7.6 – Confirmation Message Page

An e-mail is sent to the AB indicating that the notice was received by the FDA (Figure 9.7.7 –
Image depicts the email notification text only).
125

Figure 9.7.7 – E-mail Sent to AB User

You can return to the “Reports and Notifications” page by clicking the “AB Home” link in the top
of the banner.

126

Reinstatement of a Certification Body in Whole or in Part
Select the “Reinstatement of a Certification Body in Whole or in Part” link in the “Reports and
Notifications” page (Figure 9.8.1).
Figure 9.8.1 – Reinstatement of a Certification Body in Whole or in Part

127

The system displays the “Reinstatement of a Certification Body in Whole or in Part” page.
Select the Certification Body who you wish to reinstate in whole or in part, then select the
“Type of Action” (Figure 9.8.2).
Figure 9.8.2 – Reinstatement of a Certification Body in Whole or in Part Page

The following occurs based on the “Type of Action” selected:
•
•

Reinstate in whole:
• The system displays the CB’s scopes and you must provide detailed information
supporting your decision to reinstate in whole (Figure 9.8.3).
Reinstate scope(s):
• The system displays the CB’s scopes and you must select the scopes that are to be
reinstated. Then provide detailed information supporting your decision to reinstate
the selected scopes (Figure 9.8.4).

128

Figure 9.8.3 – Reinstate in whole

129

Figure 9.8.4 – Reinstate scope(s)

The system displays the “e-Signature” page (Figure 9.8.5).
Follow the directions provided on the “e-Signature” page. You must click on the check mark to
certify that the information in the submission is true and accurate and, that you are authorized
to submit the information to the FDA. The following data fields are present:
•
•

Name of Submitter - The first and last name of the application submitter.
Title of Submitter - The title of the application submitter.

Fill in the required data fields, and click the “Submit” button.

130

Figure 9.8.5 – e-Signature Page

The system will display the confirmation message (Figure 9.8.6).
Figure 9.8.6 – Confirmation Message Page

An e-mail is sent to the AB indicating that the notice was received by the FDA (Figure 9.8.7 –
Image depicts the email notification text only).

131

Figure 9.8.7 – E-mail Sent to AB User

You can return to the “Reports and Notifications” page by clicking the “AB Home” link in the top
of the banner.

132

File Type	application/pdf
File Title	Accredited Third-Party Certification Program - Electronic User Guide
Author	FDA
File Modified	2022-06-28
File Created	2018-12-06