FDA Update

It Is That Time of the Year Again…

FDA Annual Establishment Renewal and Drug Listing Certification

The annual establishment registration renewal and drug listing certification period is now open and will close on December 31, 2023. This does not apply to private label distributors. You may submit a Blanket No Changes Certification of Product Listing if you are acting as an authorized agent for the registered establishment. (Please note: mdi has been providing this service for many of our clients. For Domestic companies their Off. Corresp. and foreign companies their US Agent and Official Correspondent.)

To keep establishment registration status current in 2024, FDA must receive notification that a firm’s registration information:

1. is confirmed as accurate and no changes have occurred since the previous update,
2. was updated, or
3. will be de-registered as firm will cease operations.

How do I renew a registration with no changes?

To submit No Change Notification using CDER Direct:

• Open the previously submitted and accepted Establishment Registration SPL.
• Click Create New Version.
• Change the document type to No Change Notification
• Please note: If your FDA assigned FEI is missing, your registration renewal will fail validation. If that is the case, you will have to submit an Establishment Registration update instead of a No Change Notification.
• Submit SPL.

See step by step instructions on submitting a No Change Notification submission using CDER Direct.

To submit No Change Notification using other applications:

• Create a No Change Notification SPL document.
• Fill in the SetID with the value from your previous or most recent submission.
• Enter the appropriate effective date and version number (generally, one number higher than the previous submission)
• Submit.

How do I update establishment registration information?

To update establishment registration information using CDER Direct:

• Open the previously submitted and accepted Establishment Registration SPL.
• Click Create New Version.
• Enter the new address/DUNS or contact information that needs to be updated.
• Please note: If your FDA assigned FEI is missing, your registration update will fail validation.
• Submit SPL.

See step-by-step instructions to update establishment registration using CDER Direct.

To update establishment registration information using other applications:

• Create a copy/new version of the most recent submission.
• Do not change the SetID. Retain the original SetID from the previous version.
• Generate a new DocumentID/RootID.
• Enter an appropriate effective date and version number (generally, one number higher than the previous submission).
• Modify all establishment and contact information as appropriate and submit.

How do I de-register or submit an out of business notification?

To de-register or submit an Out of Business Notification using CDER Direct:

• Open the previously submitted and accepted Establishment Registration SPL.
• Click Create New Version.
• Change the document type to Establishment De-Registration or Out of Business Notification as appropriate and Submit SPL.

See step-by-step instructions to de-register an establishment using CDER Direct.

See step-by-step instructions to submit an Out of Business Notification using CDER Direct.

To de-register or submit an out of business notification using another application:

• Create an Establishment De-Registration SPL document.
• Fill in the SetID with the SetID from your previous submission.
• Enter the appropriate effective date and version number. (Generally, one number higher than the previous submission)
• Submit SPL.

How do I know if my registration notification was successful?

Check the status of your registration at the Drug Establishment Current Registration Site (DECRS). Once your submission is successful, your firm’s name and information will appear with the expiration date of 12/31/2023 within 24 business hours.

To keep drug listing status current in 2024, FDA must receive notification that a firm’s drug listing information: 1) is certified as accurate and no changes have occurred since the previous update, 2) was submitted or updated during 2023 calendar year, or 3) will be de-listed as manufacturing and distributing has ceased.

How do I certify drug listing data to be current and accurate?

To submit a Blanket No Changes Certification of Product Listing using CDER Direct:

• Go to product listing & certification
• Click on create new/upload file
• Select the radio button to create a new product listing or certification using a blank form
• Select the document type ? Blanket No Changes Certification of Product Listing
• Click on the check box to auto populate authorized agent details based on your CDER Direct account information
• Click on add labeler button and enter the labeler code of the product(s) you wish to certify.
• Click on refresh establishments to find all the establishments that are involved with the labeler(s) products
• Select the checkbox to choose all the establishments or just choose specific establishments. The establishment selected must not be expired or inactivated
• Once you have your establishments marked, select show products.
• Select the checkbox to choose the products you wish to certify
• Click on Save
• Submit SPL.

See step-by-step instructions to submit a Blanket No Changes Certification of Product Listing using CDER Direct.

To submit a Blanket No Changes Certification of Product Listing using other applications:

• Create a Blanket No Changes Certification of Product Listing SPL document.
• Enter the authorized agent information
• Enter the labeler and establishment information
• Enter the product NDCs you wish to certify
• Submit.

How do I know if my drug listing submission was successful?

Check the status of your listing at the Directory. Once your submission is successful, the drug listing information will appear with the listing record certified through December 31, 2024 within 24 business hours.

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Questions?

If you have any questions on the registration process or would like to use mdi as your US Agent and/or Official Correspondent please let us know. You can always change your US Agent to a new one that can also supply you all your regulatory needs (mdi is a full service FDA regulatory consulting service and as well as a registered US Agent with the US FDA).

For more information on FDA Annual Establishment Renewal and Drug Listing Certification please email us at and our US Agent services please email mdi: info@mdiconsultants.com and ref: FDA Annual Establishment Renewal and Drug Listing Certification.