506J Template User Instruction

Contents
Instructions ................................................................................................................................................... 2
Submitter Contact Info ................................................................................................................................. 3
Interruptions-Discontinuances ..................................................................................................................... 3
Medical Device Details.............................................................................................................................. 3
Reasons for Discontinuance or Interruption............................................................................................. 4
Duration .................................................................................................................................................... 5
Impact on Manufacture or Distribution of your Devices.......................................................................... 5
Critical Suppliers ....................................................................................................................................... 6
Additional Information, Including Possible Mitigations............................................................................ 6
Production Capacity and Market Share .................................................................................................... 7
No Interruption ............................................................................................................................................. 7
Identifier Information ............................................................................................................................... 7
Reasons that No Notification is Needed ................................................................................................... 8

Introduction
The purpose of this document is to provide step-by-step instructions on the use of the 506J Spreadsheet
Template for the purposes of submitting multiple notifications of interruptions or permanent
discontinuances of certain devices under section 506J of the Food, Drug, and Cosmetic Act (FD&C Act).
This document provides information about the fields/cells in which information should be entered and
troubleshooting potential issues. Please note that this Spreadsheet Template is one method for
submission of a batch of 506J Notifications. While not all of the information in the Spreadsheet
Template is required to submit a 506J notification, information that is marked with an asterisk (*) in the
Spreadsheet Template must be provided to the agency for it to be considered complete.

Instructions

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Fully read the information on the “Instructions” tab

To input information in the template, use the tabs at the bottom of the spreadsheet.

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Spreadsheet tabs

Submitter Contact Info

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Submitter First Name – Enter submitter’s first name
Submitter Last Name – Enter the submitter’s last name
Submitter E-Mail – Enter the submitter’s email address
Submitter Phone Number – Enter the submitter’s phone number
Submitter Company Name – Enter the submitter’s manufacturer or company name

Interruptions-Discontinuances
Medical Device Details

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Notification Type – Type in the cell or select from the drop-down menu “Initial” or “Update” by
selecting the drop-down arrow to the right of the field. “Initial” indicates that the submission is
the FIRST from the Manufacturer about the specific devices; “Update” indicates that the
Manufacturer has followed-up about a previous notification regarding the specific devices
FEI number – Type in the cell or choose your Firm’s Establishment Identifier (FEI) number from
the drop-down list by selecting the arrow to the right of the field

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Product Code – Type in the cell or choose the product code assigned to the device from the
drop-down list by selecting the drop-down arrow to the right of the field
Secondary or Subsequent Product Codes – If your device has been assigned multiple product
codes, you can type the additional product codes assigned to the device here separated by a
semicolon (;)
Marketing Submission Holder – Enter the name of the holder of the marketing submission, in
the case that the original submission has been transferred or sold
Submission Number – Enter the submission number associated with the device, if applicable
Device Trade Name – Enter the device trade name
UDI – Enter the Unique Device Identifier (UDI). If you are entering multiple UDI , separate them
with a semicolon (;)
Model/Catalog Number – Enter the model or catalog number, if applicable. If you are entering
multiple Model/Catalog numbers, separate them with a semicolon (;)
SKU Number – Enter the Stock Keeping Unit (SKU) number, if applicable. If you are entering
multiple SKU, separate them with a semicolon (;)
Has the interruption been Resolved – For an interruption that has since been resolved, or if
there is a change in status of a previously communicated discontinuance, type in the cell or
choose “Yes” or “No” from the drop-down list by selecting the arrow to the right of the field.
Blanks are considered “No”
Is this a pediatric device or does it include pediatric sizes – Type in the cell or choose “Yes” or
“No” from the drop-down list by selecting the arrow to the right of the field. Blanks are
considered “No”

Reasons for Discontinuance or Interruption

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Identify the reason for the discontinuance or interruption of your device. Type in the cell or
choose “Yes” or “No” from the drop-down list by selecting the arrow to the right of the field.
Blanks are considered “No”. If the reason for your discontinuance or interruption is not
described by one of the reasons identified, use the “Other Reasons” field to type the reason for
your discontinuance or interruption. This is a required field and a reason must be identified for
the discontinuance or interruption either by indicating “Yes” in one of the fields or typing a
reason in the “Other Reasons” field. Multiple reasons can be selected.

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Duration

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Estimated Duration Start Date – Enter the estimated duration start date, if the exact date of the
month cannot be identified, enter the first of the month
Estimated Duration End – Enter the estimated duration end date, if the exact date of the month
cannot be identified, enter the end of the month. If a date cannot be identified and the end can
be described in another way (for example, end of pandemic), use the “Other” field to type when
the discontinuance or interruption will be resolved or if the date is unknown. An end date
should be estimated by either entering a date or typing a duration in the “Other” field

Impact on Manufacture or Distribution of your Devices

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5

Answer the identified questions to explain the impact of the discontinuance or interruption on
the manufacture or distribution of your devices. Type in the cell or choose “Yes” or “No” from
the drop-down list by selecting the arrow to the right of the field. Blanks are considered “No”. If
additional issues have occurred, use the “Other Issues” field to explain.

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Critical Suppliers

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Type in the cell or choose “Yes” or “No” from the drop-down list by selecting the arrow to the
right of the field. Blanks are considered “No”. Use the “Supplier Information” field to identify
and critical suppliers that might affect your device

Additional Information, Including Possible Mitigations

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Type in the cell or choose “Yes” or “No” from the drop-down list by selecting the arrow to the
right of the field. Blanks are considered “No”. If you have a proposal to expedite the availability
of device type it in the “Proposal to expedite availability” field. If you have a shortage mitigate
plan, type it in the “Describe your shortage mitigation” field.

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Production Capacity and Market Share

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Estimated US Market Share – Enter an estimate of your facility’s percent US market share for
the specific device. This is the percentage of the market share at the identified FEI produces
when compared to other facilities and manufacturers
Average Historic Production Volume – Enter your average historic production volume per month
Average Historic US distribution – Enter your average historic US distribution per month
Current Production Volume – Enter your current production volume per month
Current US distribution – Enter your current US distribution per month
Maximum Production Volume – Enter your maximum production volume per month
Current Device Inventory – Enter your current device inventory in individual units (eaches)

No Notification
Please note that if you are currently not experiencing an interruption or permanent discontinuance in
manufacturing that requires the submission of a 506J notification, you may also complete the Voluntary
Online Notification form on the online webform. Select “Voluntarily Indicate No Current Interruption or
Permanent Discontinuance” on the webform. If you have a large volume to voluntarily report, you may
use the spreadsheet template.

Identifier Information

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FEI number – Type in the cell or choose your Firm’s Establishment Identifier (FEI) number from
the drop-down list by selecting the arrow to the right of the field
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Product Code – Type in the cell or choose the product code assigned to the device from the
drop-down list by selecting the drop-down arrow to the right of the field
Secondary/Subsequent Product Codes – If your device has been assigned multiple product
codes, you can type the additional product codes assigned to the device here separated by a
semicolon (;)

Voluntarily Indicate Currently No Notification under 506J

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Type in the cell or choose “Yes” or “No” from the drop-down list by selecting the arrow to the
right of the field. Blanks are considered “No”. If additional reasons are needed, use the “Other
Reasons” field to explain.

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Contents

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

Notification Information ............................................................................................................................... 1
Identifier Information ................................................................................................................................... 2
Reason(s) for discontinuance or interruption............................................................................................... 5
Duration of discontinuance or interruption ................................................................................................. 6
COVID-19 pandemic-specific inquiries.......................................................................................................... 8
Additional Information, including possible mitigations.............................................................................. 10
Production Capacity and Market Share for this FEI and product code ...................................................... 12
End of Form and Attachments .................................................................................................................... 12
Submitting a Spreadsheet....................................................................................................................... 13
If voluntarily indicating no interruption or permanent discontinuance................................................. 13
Error Messages ........................................................................................................................................... 14

August 2021

Introduction

The purpose of this document is to provide step-by-step instructions on how to input information into
the 506J Notification Webform for the purposes of submitting a notification of interruption or
permanent discontinuance of certain devices under section 506J of the Food, Drug, and Cosmetic Act
(FD&C Act). This document provides information about the fields in which information should be
entered, troubleshooting issues, and potential error messages which may be displayed. Please note that
the 506J Notification Webform is one method to submit a 506J notification to FDA. While not all of the
information in the webform is required to submit a 506J notification, information that is marked with an
asterisk (*) must be provided in the webform for it to be transmitted to the agency.
Please use Chrome, Microsoft Edge, or Firefox to fill out the webform. The webform is incompatible
Internet Explorer.

Notification Information

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1

Submitter First Name – Type your first name into this field (character limit: 25)
Submitter Last Name – Type your last name into this field (character limit: 25)
Submitter Email Address – Type your email address into this field (character limit: 80)
Submitter Phone – Type phone number into this field (character limit: 40)
Submitter Company Name – Type full Owner/Operator name into this field. This field can be
expanded by dragging the bottom right corner of the field up and down. (character limit 255)

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Identifier Information

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Notification Type –Select the drop-down arrow and select “Initial” or “Update.” “Initial”
indicates the submission is the FIRST from the Manufacturer for the specific FEI number or
product code. “Update” indicates that the Manufacturer has followed-up on the first submission
to the FDA for specific FEI number or product code.

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FEI Number – Begin typing your FEI number and then select it from the dropdown list by
Selecting in the list. Once selected the FEI number will display with the icon next to the number.

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If your FEI number does does not appear, verify that you have the correct FEI number
with the Establishment Registration and Device Listing database or the FEI Portal, see
FAQs for more details
o If you have verified you have the correct FEI number and it is still not appearing in the
list contact the Agency at CDRHManufacturerShortage@fda.hhs.gov and include
“Question” in the subject line of the email
Product Code – Begin typing your product code and select it from the dropdown list. Once
selected, the product code will display with the icon next to the number.
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If you do not know your product code, you can find that information in the
Establishment Registration and Device Listing database.
If your device has subsequent/secondary product codes, select “Add
Secondary/subsequent Product Code” and follow the steps above

If you have entered subsequent/secondary product codes in error, select the trash can
icon to the right of the extra Product Code fields (this icon only appears for
subsequent/secondary product codes)
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If your product code is not available, please contact the FDA for further instruction at
CDRHManufacturerShortage@fda.hhs.gov and include “Product Code” in the subject
line. Include your name, organization, and contact information and an FDA team
member will contact you with instructions on how to submit your notification.

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Marketing Submission Holder – In the case that the original submission has been transferred or
sold, type the name of the marketing submission holder. This field can be expanded by dragging
the bottom right corner of the field up and down. (character limit: 20,000)

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Marketing Submission Number – Type the submission number for the product. If there is more
than one submission number associated with your product, separate them with semicolons (;).
This field can be expanded by dragging the bottom right corner of the field up and down.
(character limit: 255)

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Device Trade Name – Type the device trade name. If there is more than one, separate them with
semicolons (;). This field can be expanded by dragging the bottom right corner of the field up
and down. (character limit: 20,000)

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UDI– Type the Unique Device Identifier (UDI). If there is more than one, separate them with
semicolons (;). This field can be expanded by dragging the bottom right corner of the field up
and down. (character limit: 5,000)

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Model/Catalog Numbers – Type the model or catalog numbers. If there is more than one,
separate them with semicolons (;). This field can be expanded by dragging the bottom right
corner of the field up and down. (character limit: 20,000)

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SKU Numbers – Type the SKU numbers. If there is more than one, separate them with
semicolons (;). (character limit: 255)

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For an interruption that has since been resolved, or if there is a change in status of a previously
communicated permanent discontinuance, select the box under the question. Selecting this box
will end the form and give you the option to add another entry, submit and close, or add files

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For a pediatric device –Select the box under the question if the device is a pediatric device or
comes in a pediatric size

Reason(s) for discontinuance or interruption

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Reason(s) for discontinuance or interruption – Select the reason(s) for the discontinuance or
interruption by selecting the reason from the list available and selecting the right arrow
between the “Available” and “Chosen” boxes. Multiple reasons can be moved at once by
holding the control (Ctrl) key while selecting. You can scroll through all the options by using the
small scroll bar on the right of the “Available” box.

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If a reason is incorrectly selected, it can be removed by selecting the reason and then selecting
the left arrow between the “Available” and “Chosen” boxes.

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If none of the reasons listed under the “Available” box describe the reason for your
discontinuance or interruption, a text box is available for you to type a different reason that fits
your situation. Select “Other reasons not listed above, description below” and then enter
information into the provided text box. This field can be expanded by dragging the bottom right
corner of the field up and down. (character limit: 20,000)

Duration of discontinuance or interruption

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Estimated Duration Start Date –Select this field and use the calendar that appears and select the
approximate start date of your discontinuance or interruption. The month can be changed by
selecting the left and right arrows at the top; the year can be changed by selecting the field and
selecting the correct year. If the exact start date is not known, but the month/year is known,
enter the first day of the month.

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Estimated Duration End Date –Select this field and use the calendar that appears and select the
approximate end date of your discontinuance or interruption. The month can be changed by
selecting the left and right arrows at the top; the year can be changed by selecting the field and
selecting the correct year. If the end date is not known, but the month/year is known, enter the
last day of the month. The estimated end date must be after the estimated start date if one is
provided.

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Estimated Duration Other – If the duration of your discontinuance or interruption cannot be
estimated to a date, this field can be utilized to type a response to describe the estimated
duration. This field can be expanded by dragging the bottom right corner of the field up and
down. (character limit: 20,000)

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COVID-19 pandemic-specific inquiries

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Has the COVID-19 pandemic further affected your ability to manufacture or distribute your
device(s)? – Select the reason(s) that have impacted your ability to manufacture or distribute
your device(s) by selecting the reason from the list available and selecting the right arrow
between the “Available” and “Chosen” boxes. Multiple reasons can be moved at once by
holding the control (Ctrl) key while selecting. You can scroll through all the options by utilizing
the small scroll bar on the right of the “Available” box.

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If a reason is chosen accidentally, use the left arrow between the “Available” and “Chosen”
boxes to remove a chosen reason.

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If none of the reasons listed under “Available” describe the reason for your discontinuance or
interruption, a text box is available for you to type a different reason that fits your situation.
Select “Other reasons not listed above, description below” if you are going to use this text box.

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This field can be expanded by dragging the bottom right corner of the field up and down.
(character limit: 20,000)

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Do you rely on any critical suppliers that might be affected by the COVID-19 pandemic? – The
default answer for this question is “None”; to select “Yes” or “No,” use the drop-down menu.

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If “Yes” is selected, provide a description in the text field to the right of this question. If your
answer does not fit in the text field, provide information as an attachment. There is an “Add
files” button at the bottom of this form to upload files as attachments. This field can be
expanded by dragging the bottom right corner of the field up and down. (character limit:
32,768)

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Additional Information, including possible mitigations

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Is this device manufactured on multiple lines – The default answer for this question is “None”;
to select “Yes” or “No,” use the drop-down menu.

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Is this device manufactured in multiple facilities – The default answer for this question is
“None;” to select “Yes” or “No,” use the drop-down menu.

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Have you provided, or will you provide public information to your stakeholders and patients
regarding this actual or potential shortage? – The default answer for this question is “None;” to
select “Yes” or “No,” use the drop-down menu.

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Do you have a proposal for FDA to review to expedite availability of your device? – The default
answer for this question is “None;” to select “Yes” or “No,” use the drop-down menu.
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If “Yes” is selected, you may provide a description in the text field to the right of this question
with your proposal to expedite availability of the device and/or for FDA to help prevent or
mitigate a supply distribution. If your answer does not fit in the text field, provide information
as an attachment. There is an “Add files” button at the bottom of this form to upload files as
attachments. This field can be expanded by dragging the bottom right corner of the field up and
down. (character limit: 32,768)

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Do you have shortage mitigation plans in place that could be shared with FDA – The default
answer for this question is “None;” to select “Yes” or “No,” use the drop-down menu.

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If “Yes” is selected, provide a description in the text field below this question. If your answer
does not fit in the text field, provide information as an attachment. There is an “Add files”
button at the bottom of this form to upload files as attachments. This field can be expanded by
dragging the bottom right corner of the field up and down. (character limit: 32,768)

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Production Capacity and Market Share for this FEI and product code

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Estimated US market share (%) for this device – Enter a number between 0 – 100 (character
limit: unlimited but numerical values only)
Average Historic Production Volume per Month – Enter a number (character limit: 14 numbers)
Average Historic US Distribution per Month – Enter a number (character limit: 14 numbers)
Current Production Volume per Month – Enter a number (character limit: 14 numbers)
Current US Distribution per Month – Enter a number (character limit: 14 numbers)
Maximum Product Volume per Month – Enter a number (character limit: 14 numbers)
How much device inventory do you have? –Enter a number that approximates how much
inventory you currently have in individual units (eaches). This field can be expanded by dragging
the bottom right corner of the field up and down. (character limit: 20,000)

End of Form and Attachments

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At the end of this form, there are three options:
o Add another entry – if you have another interruption or discontinuance to report, for a
different product code or a different FEI number, select this option to enter this form
and create another, with some fields pre-populated
o Submit and close – if you are done entering interruptions or discontinuances, select this
option to submit the form to FDA and close the window
o Submit and add attachments – if you would like to provide more information that was
not captured in the form or a section of the form did not have enough space for you to
provide your full answer, select “Submit and add files add attachments” and the Add
Attachments section will become available. You can upload a PDF, Word, or Excel file,
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the file size cannot exceed 5 MB per file. When you are done uploading files, select the
“Finish” button

Submitting a Spreadsheet
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To submit notification with a spreadsheet, fill out the spreadsheet template. See: How to Use
the 506J Notification Spreadsheet Template for help.
Select add files.

Select the template spreadsheet you filled with your information
Files successfully uploaded with appear below the Upload Files button and a green banner will
appear

If voluntarily indicating no interruption or permanent discontinuance
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Voluntarily Indicate Currently No Notification Under 506J – You may wish to voluntarily indicate
that you are not currently experiencing an interruption or permanent discontinuance in
manufacturing for a device that requires the submission of a 506J notification. Information that
is marked with an asterisk (*) must be provided for it to be transmitted to the agency. Indicate
whether you are not experiencing an interruption or permanent discontinuance by selecting the
reason from the list and selecting the right arrow between the “Available” and “Chosen” boxes.
Multiple reasons can be moved at once by holding the control (Ctrl) key while selecting. You can
scroll through all the options by utilizing the small scroll bar on the right of the “Available” box.

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•

If a reason is incorrectly selected, it can be removed by selecting the reason and then selecting
the left arrow between the “Available” and “Chosen” boxes.

Error Messages

Enter a valid value
• This error occurs when text is entered into a field that is expecting a numerical value. These
fields are mainly in the Production Capacity and Market Share and FEI field.

Product Code not found see FAQ
• This error occurs when the product code that is being entered is not one of the device types that
currently require notification under section 506J of the FD&C Act.

FEI number not found see FAQ
• This error occurs when the FEI number entered is either not entered correctly or is not
registered as a device establishment in the webform. You can look up your FEI number in the
Establishment Registration and Device Listing database or the FEI Search portal.

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Enter a value
• This error occurs when a required field has not been completed.

You have entered an invalid format
• This error occurs when a valid email address is not entered. The email address should include
the @ symbol with text before and after.

•

This error also occurs when a valid email address is not entered. The email address should
include a domain name (.com, .gov, .edu, etc.)

Upload errors
• The size of the file exceeded 5 MB or is an incompatible file type

Your entry does not match the allowed format MMM d, yyyy
• This error occurs when a date is typed into the start date or end date fields instead of utilizing
the pop-up calendar and selecting the appropriate date. Use the pop-up calendar to select the
date.

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Estimated duration start date should be less than estimated duration end date
• This error occurs when an end date is reported at a time prior to the reported start date.

Required field errors
• These errors occur when required fields have not been completed.

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Online 506J Notification Submission Methods: Frequently
Asked Questions
This page responds to common questions on online 506J notification submission
methods, including the webform and spreadsheet template, under section 506J of the
Federal Food, Drug, and Cosmetic (FD&C) Act during the COVID-19 pandemic.
On this page:
Webform FAQs
Spreadsheet Template FAQs

Webform FAQs
Q. How do I submit notifications using the webform? Where can I find help if I
have trouble using the webform?
A. Please see the How to Use the FDA 506J Notification Webform (/media/151055/download)
for more information on submitting information through the webform, troubleshooting, and
answers to frequently asked questions on the webform.
Q. Is the information I submit using the webform secure?
A. The FDA 506J Notification webform (https://fdaprod.force.com/shortages) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer) complies with Hypertext
Transfer Protocol Secure (HTTPS) messaging standards and uses digital certificates for secure
communication.
Q: What is the purpose of the “Voluntarily Indicate No Current Interruption or
Permanent Discontinuance” option on the online webform?
A: If a manufacturer is currently not experiencing an interruption or permanent discontinuance
in manufacturing, they may voluntarily indicate this to the FDA selecting this option and filling
out the form.
Q. Are there other ways than the webform to submit a 506J Notification?
A. The FDA recommends using the webform (https://fdaprod.force.com/shortages) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer) to submit your
notification. However, there are alternate methods to submit a 506J notification. For example, if
you do not utilize the webform, manufacturers may email their information to

CDRHManufacturerShortage@fda.hhs.gov (mailto:CDRHManufacturerShortage@fda.hhs.gov?
subject=Notification) and begin the email subject line with the word "Notification." Section V of
the guidance, Notifying CDRH of a Permanent Discontinuance or Interruption in
Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public
Health Emergency (Revised) (/regulatory-information/search-fda-guidancedocuments/notifying-cdrh-permanent-discontinuance-or-interruption-manufacturing-deviceunder-section-506j-fdc), provides an example 506J notification
(https://www.fda.gov/media/137712/download#page=13) intended to illustrate the type of
information that the FDA recommends be included in a notification.
Q. I’m having trouble loading the form in my web browser. Are there certain web
browsers that work better than others?
A. Please use Chrome, Microsoft Edge, or Firefox to fill out the webform. The webform does not
support Internet Explorer.
Q. Can I see what information I have submitted previously?
A. No, once the webform is submitted, the information is sent to the FDA and is not saved
within the webform. If you have a question about the information you submitted, please email
CDRHManufacturerShortage@fda.hhs.gov (mailto:CDRHManufacturerShortage@fda.hhs.gov)
and include “Question” in the subject line of the email.
Q. Can I use multiple methods to submit information using the webform?
A. Yes, you can submit notifications through any or all of the three methods in the webform (for
example, webform, spreadsheet, voluntary notification). Once you’ve completed and submitted
notification using one method, you will be redirected to the webform home page
(https://fdaprod.force.com/shortages)  (http://www.fda.gov/about-fda/websitepolicies/website-disclaimer), where you can select a different method.
Q. How do I know if the FDA received my webform submission?
A. Once you have submitted a 506J notification through the webform, a confirmation email will
be sent to the identified contact’s email address. To inform possible mitigation efforts, the FDA
may follow up with manufacturers or conduct targeted outreach where an interruption is crosscutting or may have the potential to impact users. However, you will not routinely hear from the
FDA once the FDA has analyzed the information.
The FDA will publicly communicate updates to the device shortage list and device
discontinuance list. Any information that is trade secret or confidential information will be
treated as such, consistent with section 552(b)(4) of title 5, United States Code, section 1905 of
title 18, United States Code, section 520(c) of 21 USC 360J(c), and other applicable laws.

Q. What if I want to provide the FDA with additional information than is required
or requested? How can I submit that information?
A. When using the webform (https://fdaprod.force.com/shortages) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer), you may attach
additional documents if there is additional information you wish to provide to the FDA. Select
“Add files” at the bottom of the page and the option to add attachments will become available.

Q. How do I submit a 506J notification for a product code that is not available on
the webform?
A. If your product code is not available, please contact the FDA for further instruction at
CDRHManufacturerShortage@fda.hhs.gov (mailto:CDRHManufacturerShortage@fda.hhs.gov)
and include “Product Code” in the subject line. Include your name, organization, and contact
information and an FDA team member will contact you with instructions on how to submit your
notification.
Q. How do I submit a 506J notification for an FEI that is not available on the
webform?
A. If you are having trouble locating your FEI number, see How to Determine FEI, product
code, and submission number (https://www.accessdata.fda.gov/scripts/feiportal/index.cfm?
action=portal.login) for information on how to locate your firm’s establishment information. If
you are still unable to locate your establishment’s FEI number in the webform, please email
CDRHManufacturerShortage@fda.hhs.gov (mailto:CDRHManufacturerShortage@fda.hhs.gov)
and include “Question” in the subject line.
Q. There are three different notification options on the webform. How do I know if
I have a “small” or “large” amount of FEI-product codes to enter?
A. The FDA recommends submitting 506J notifications using the method that is most
convenient for you.

Generally, for a manufacturer having between 5 and 10 FEI-product code combinations,
submitting 506J notifications directly through the webform may be easiest.
For a manufacturer having over 10 FEI-product code combinations, the spreadsheet template
may be a more convenient method to submit a 506J notification. You can then submit it to the
FDA in your initial notification, as well as use it to collect any revised information for update
notifications.
The webform is updated weekly to include new information from Registration & Listing;
however, the format of the spreadsheet will not change.
Q. I ran out of character space in a box. How can I add more context to my answer?
A. If you have exceeded the character limit in a text box field, an additional file can be attached
to your submission that contains any additional information. Please find the option to attach a
file at the bottom of the form.
Q. What if the options for the reason for interruption don’t fully explain my
situation?
A. You have the option to select several reasons for the discontinuance or interruption as well as
an option of “Other.” An open text field is below this question where you can explain the reason
for the discontinuance or interruption if you feel the options don’t explain your situation.
Additionally, there is an option to attach a file at the end of your submission.
Q. Is there a way of notifying the FDA that I do not currently have an interruption
or permanent discontinuance?
A. Yes. If you are not currently experiencing an interruption or discontinuance in
manufacturing, you may voluntarily notify the FDA using the “Voluntarily Indicate No Current
Interruption or Permanent Discontinuance (https://fdaprod.force.com/shortages) 
(http://www.fda.gov/about-fda/website-policies/website-disclaimer)” option on the webform.
Q. Where can I find more information about 506J notifications?
A. See Medical Device Supply Chain Notifications During the COVID-19 Pandemic (/medicaldevices/coronavirus-covid-19-and-medical-devices/medical-device-supply-chain-notificationsduring-covid-19-pandemic) for more information about 506J notifications. For answers to
frequently asked questions about the device shortage list, who to contact, or 506J Notifications
in general, please see Supplies of Medical Devices for COVID-19: Frequently Asked Questions
(/medical-devices/coronavirus-covid-19-and-medical-devices/supplies-medical-devices-covid19-frequently-asked-questions).

Spreadsheet Template FAQs
Q. How do I submit large numbers of notifications using the spreadsheet? Where
can I find help if I have trouble entering information in the spreadsheet?
A. Please see the How to Use the 506J Notification Spreadsheet Template
(/media/151056/download) for more information on submitting information through the
webform, troubleshooting, and answers to frequently asked questions on the webform.
Q. Can I submit a spreadsheet that does not use the FDA spreadsheet template
using the webform?
A. No. Spreadsheet files that are not formatted in the FDA spreadsheet template
(/media/151057/download) will not be able to be processed correctly. If you are experiencing
problems with the FDA template spreadsheet, email CDRHManufacturerShortage@fda.hhs.gov
(mailto:CDRHManufacturerShortage@fda.hhs.gov) and include “Question” in the subject line.

Use Chrome, Microsoft Edge, or Firefox to fill out the webform. The webform does not support
Internet Explorer.

Notify the FDA About an Interruption or Permanent
Discontinuance in Device Manufacturing (506J
Notification)
Under Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), manufacturers of the
following devices must notify the FDA of an interruption or permanent discontinuance in
manufacturing during or in advance of a public health emergency.
Devices that are critical to public health during a public health emergency, including those that are
life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery.
Devices for which the FDA determines information on potential meaningful supply disruptions is
needed during a public health emergency.
This page provides an electronic method for submitting 506J notifications, as well as other voluntary
notifications, to FDA. The FDA recommends submitting 506J notifications in the method that is most
convenient for you. The webform is updated to include new information from Registration & Listings.

OMB # 0910-0491, exp. 06/30/2024

For help using the notification options below, refer to the following How To documents:

How to use the FDA 506J Notification Webform (https://www.fda.gov/media/151055/download)
How to use the 506J Notification Spreadsheet Template
(https://www.fda.gov/media/151056/download)
FAQs on FDA’s online 506J Notification submissions methods (https://www.fda.gov/medicaldevices/coronavirus-covid-19-and-medical-devices/online-506j-notification-submission-methodsfrequently-asked-questions)
Common error messages when using the 506J Notification webform
(https://www.fda.gov/media/151055/download#page=13)
Note: If you are experiencing an interruption or discontinuance of a device that may not be related to
a public health emergency response, but you would still like to voluntarily notify FDA, you may submit
that information using either the webform or spreadsheet.

Notify FDA using webform:
Complete the Online Notification using this form, you can submit individual notifications.
Submit Notifications Online

Notify FDA using a spreadsheet:
Submit Notifications Using a
Complete the Online Notification and submit a spreadsheet with a batch of notifications.
Spreadsheet

Voluntarily indicate there is not an interruption or permanent
discontinuance:
If you are currently not experiencing an interruption or permanent discontinuance in
manufacturing that requires the submission of a 506J notification, you may complete the
Voluntary Online Notification form.
Voluntarily Indicate No Current
Interruption or Permanent
Discontinuance

For more information about section 506J of the FD&C Act, see:

Contact the FDA About a Medical Device Supply Chain Issue (https://www.fda.gov/medicaldevices/medical-device-safety/contact-fda-about-medical-device-supply-chain-issue)
Medical Device Types to Help Determine Section 506J Notification Obligations
(https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-devicetypes-help-determine-section-506j-notification-obligations)

For questions about medical device shortages and notifications under section 506J of the Federal
Food, Drug, and Cosmetic (FD&C) Act during the COVID-19 pandemic, refer to Supplies of Medical
Devices for COVID-19: Frequently Asked Questions. (https://www.fda.gov/medicaldevices/coronavirus-covid-19-and-medical-devices/supplies-medical-devices-covid-19-frequentlyasked-questions) If your question is not answered by the FAQ, you can email
CDRHManufacturerShortage@fda.hhs.gov (mailto: CDRHManufacturerShortage@fda.hhs.gov) and
include “Question” in the subject line of the email.

Website Policies /Privacy (https://www.fda.gov/about-fda/about-website/website-policies)||Vulnerability Disclosure Policy
(https://www.hhs.gov/vulnerability-disclosure-policy/index.html)

Submit Notifications Online
orm is one method for submission of a 506J Notification. Using this form, you can submit individual notifications for e
ion or discontinuance. While not all of the information in the webform is required to submit a 506J notification, inform
arked with an asterisk (*) must be provided in the webform for it to be transmitted to the agency.
ve more than one FEI-product code combination, complete the form and select the "Add another interruption or
uance" button at the bottom of the form to add the next FEI-product code combination.

using the webform, refer to the following How To documents:

o use the FDA 506J Notification Webform (https://www.fda.gov/media/151055/download)
on FDA’s online 506J Notification submissions methods (https://www.fda.gov/medical-devices/coronavirus-covid-19-a
al-devices/online-506j-notification-submission-methods-frequently-asked-questions)
methods for submitting notifications to FDA, as well as links to additional resources on section 506J of the FD&C Act,
e FDA About an Interruption or Permanent Discontinuance in Device Manufacturing (506J Notification).
www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-supply-chain-notifications-d
pandemic#notifying)

cation Information
ed) Submitter First Name

* (required) Submitter Last Name

ed) Submitter Email Address

* (required) Submitter Phone

ed) Submitter Company Name

ifier Information
* (required) FEI Number (Begin typing the number and select it from the
uired) Notification Type

one--

dropdown list)

FEI Number

uired) Product Code (Begin typing the product code and select it from the
own list)

duct Code
ce is associated with more than one product code, select the 'Add Secondary/Subsequent Product Code' button below to add each product code.
d Secondary/Subsequent Product Code

ting Submission Holder

Marketing Submission Number (if more than one, use semicolons to separat
numbers)

e Trade Name (if more than one, use semicolons to separate the names)

Unique Device Identifier (UDI) (if more than one, use semicolons to separate
each identifier)

/Catalog Numbers (if more than one, use semicolons to separate the
ers)
SKU Numbers (if more than one, use semicolons to separate the numbers)

if you previously notified the FDA of an interruption that has since been resolved, or if there is a change in status of a previously communicated permanent
tinuance.

a pediatric device or includes pediatric sizes.

son(s) for discontinuance or interruption
uired) Reason(s) for discontinuance or interruption
ble

Chosen

uirements related to complying with good manufacturing practices
ulatory delay
er to divert devices from other US government entities
rtage or discontinuance of a component, part or accessory of the …

reasons not listed

ation of discontinuance or interruption
a value for either "Estimated Duration End Date" OR "Estimated Duration Other"
ted Duration Start Date

*Estimated Duration End Date

ated Duration Other

VID-19 pandemic-specific inquiries
e COVID-19 pandemic further affected your ability to manufacture or distribute your device(s)?
ble

Chosen

or shortages
k of protective equipment for employees
rtage or delay in raw material supply

onal details of issue(s).

If yes, describe the impact and supplier(s), including how reliance on critical
suppliers affected by the COVID-19 pandemic might adversely impact your
ability to manufacture device(s), and names of your critical supplier(s). If you
information will not fit in this text box, provide the information as an
u rely on any critical suppliers that might be affected by the COVID-19

attachment.

mic?

one--

ditional Information, including possible mitigations
device manufactured on multiple lines?

one--

Is this device manufactured in multiple facilities?

--None--

you provided, or will you provide, public information for your stakeholders
atients regarding this actual or potential shortage?

one--

u have a proposal for FDA to review to expedite availability of your device?
else do you think FDA can do to help prevent or mitigate a supply
tion?

Proposal to expedite availability of device and/or for FDA to help prevent or
mitigate a supply distribution.

one--

u have shortage mitigation plans in place that could be shared with the FDA?

one-describe your shortage mitigation plans or add attachment.

duction Capacity and Market Share for this FEI and product code
ted US market share (%) for this device

ge Historic US Distribution per Month

Average Historic Production Volume per Month

Current Production Volume per Month

nt US Distribution per Month

Maximum Production Volume per Month

much device inventory do you have? Enter in individual units (eaches).

Add anothe
Submit and close

Submit and add attach

d Attachments
the form has been submitted, you will be able to upload files as attachments.
uired) Upload files using the PDF, Word or Excel formats. The file attachment size should be 5 MB or less.

Upload Files

ions about medical device shortages and notifications under section 506J of the Federal Food, Drug, and Cosmetic (FD
e COVID-19 pandemic, refer to Supplies of Medical Devices for COVID-19: Frequently Asked Questions.
www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/supplies-medical-devices-covid-19-frequent
estions) If your question is not answered by the FAQ, email CDRHManufacturerShortage@fda.hhs.gov (mailto:
nufacturerShortage@fda.hhs.gov) and include “Question” in the subject line of the email.

Submit Notifications Using a Spreadsheet
You may use the Spreadsheet Template (https://www.fda.gov/media/151057/download) to
submit a batch of 506J notifications.
Instructions: The Spreadsheet Template (https://www.fda.gov/media/151057/download) is one
method for submission of a batch of 506J Notifications.
While not all of the information in the
Spreadsheet Template (https://www.fda.gov/media/151057/download) is required to submit a
506J notification, information that is marked with an asterisk (*) in the Spreadsheet Template
(https://www.fda.gov/media/151057/download)
must be provided to the agency for it to be
considered complete. Enter each FEI-product code combination on a separate row of the
Spreadsheet Template (https://www.fda.gov/media/151057/download). Once you enter your
data into the Spreadsheet Template (https://www.fda.gov/media/151057/download) you can
upload it by selecting the “add attachments” button below.

For help using the spreadsheet, refer to the following documents:

How to use the FDA 506J Notification Webform
(https://www.fda.gov/media/151055/download)
How to use the 506J Notification Spreadsheet Template
(https://www.fda.gov/media/151056/download)
FAQs on FDA’s online 506J Notification submissions methods (https://www.fda.gov/medicaldevices/coronavirus-covid-19-and-medical-devices/online-506j-notification-submissionmethods-frequently-asked-questions)
For other methods for submitting notifications to FDA, as well as links to additional resources
on section 506J of the FD&C Act, see Notify the FDA About an Interruption or Permanent
Discontinuance in Device Manufacturing (506J Notification). (https://www.fda.gov/medicaldevices/coronavirus-covid-19-and-medical-devices/medical-device-supply-chain-notificationsduring-covid-19-pandemic#notifying)
Note: There is a 5 MB limit for the uploaded files.

Notification Information
* (required) Submitter First Name

* (required) Submitter Last Name

* (required) Submitter Email Address

* (required) Submitter Phone

* (required) Submitter Company Name

Submit and add attachments

Add Attachments
Once the form has been submitted, you will be able to upload files as attachments.
* (required) Upload files using the PDF, Word or Excel formats. The file attachment size should be 5 MB or less.

Upload Files

Finish

For questions about medical device shortages and notifications under section 506J of the
Federal Food, Drug, and Cosmetic (FD&C) Act during the COVID-19 pandemic, refer to Supplies
of Medical Devices for COVID-19: Frequently Asked Questions. (https://www.fda.gov/medicaldevices/coronavirus-covid-19-and-medical-devices/supplies-medical-devices-covid-19frequently-asked-questions) If your question is not answered by the FAQ, email
CDRHManufacturerShortage@fda.hhs.gov (mailto: CDRHManufacturerShortage@fda.hhs.gov)
and include “Question” in the subject line of the email.

Voluntarily Indicate No Current Interruption or
Permanent Discontinuance
This form may be used if you wish to voluntarily indicate that you are not currently
experiencing an interruption or permanent discontinuance in manufacturing for a device that
requires the submission of a 506J notification. Information that is marked with an asterisk (*)
must be provided for it to be transmitted to the agency.

If you have more than one FEI-product code combination, you may complete the form and
select the “Add another entry” button at the bottom of the form to add the next FEI-product
code combination.

Notification Information
* (required) Submitter First Name

* (required) Submitter Last Name

* (required) Submitter Email Address

* (required) Submitter Phone

* (required) Submitter Company Name

Reason(s) no Notification is needed
* (required) Reason(s) no Notification is needed (May choose one or more)
Available

No longer manufacturing product
No interruption in manufacturing of product
Product is not used towards COVID-19 treatment …
Other reasons not listed above, description below.

Other reasons not listed

Chosen

Identifier Information
* (required) FEI Number (Begin typing the number
and select it from the dropdown list)

FEI Number
* (required) Product Code (Begin typing the product
code and select it from the dropdown list)

Product Code
If device is associated with more than one product code, select the 'Add Secondary/Subsequent Product Code'
button below to add each product code.
Add Secondary/Subsequent Product Code

Add another entry
Submit and close

Submit and add attachments

Add Attachments
Once the form has been submitted, you will be able to upload files as attachments.
* (required) Upload files using the PDF, Word or Excel formats. The file attachment size should be 5 MB or less.

Upload Files

Finish

For questions about medical device shortages and notifications under section 506J of the
Federal Food, Drug, and Cosmetic (FD&C) Act during the COVID-19 pandemic, refer to Supplies
of Medical Devices for COVID-19: Frequently Asked Questions. (https://www.fda.gov/medicaldevices/coronavirus-covid-19-and-medical-devices/supplies-medical-devices-covid-19frequently-asked-questions) If your question is not answered by the FAQ, email
CDRHManufacturerShortage@fda.hhs.gov (mailto: CDRHManufacturerShortage@fda.hhs.gov)
and include “Question” in the subject line of the email.