mdi Consultants, IncFDA Update
: info@mdiconsultants.com
: 516-482-9001
The annual drug establishment registration renewal and drug listing certification period is open October 1 to December 31, 2026. Here is how to renew, update, de-register and certify.
Since
1978
mdi has provided FDA services to the regulated industries since 1978, assisting clients worldwide with drug establishment registrations and, where necessary, product listings. We are here to assist you. If you run into any problems, contact us at info@mdiconsultants.com, re: Annual Registration 2027.
The re-registration reminder does not apply to your operations. You may submit a Blanket No Changes Certification of Product Listing if you act as authorized agent for the registered establishment.
To maintain your establishment registration status for 2027, FDA must receive notification that your firm’s registration information:
01
Is confirmed as accurate, with no changes since the previous update
02
Has been updated
03
Will be de-registered because your firm will cease operations
Using CDER Direct
Submit a “No Change Notification” in CDER Direct
1
Open the previously submitted and accepted “Establishment Registration Structured Product Labeling” (SPL).
2
Click “Create New Version.”
3
Change the document type to “No Change Notification.”
4
Submit SPL.
Using other applications
Create a “No Change Notification” SPL document
1
Fill in the Set ID with the value from your previous or most recent submission.
2
Enter the appropriate effective date and version number (generally, one number higher than the previous submission).
3
Submit.
Using CDER Direct
1
Open the previously submitted and accepted “Establishment Registration SPL.”
2
Click “Create New Version.”
3
Enter the new address, DUNS or contact information that needs to be updated.
4
Submit SPL.
Using other applications
Create a copy / new version of the most recent submission
1
Do not change the SetID. Retain the original SetID from the previous version.
2
Generate a new DocumentID / RootID.
3
Enter an appropriate effective date and version number (generally, one number higher than the previous submission).
4
Modify all establishment and contact information as appropriate and submit.
Using CDER Direct
1
Open the previously submitted and accepted “Establishment Registration SPL.”
2
Click “Create New Version.”
3
Change the document type to “Establishment De-Registration” or “Out of Business Notification” as appropriate, and submit SPL.
Using other applications
Create an “Establishment De-Registration SPL” document
1
Fill in the SetID with the SetID from your previous submission.
2
Enter the appropriate effective date and version number (generally, one number higher than the previous submission).
3
Submit SPL.
Check your status at the Drug Establishment Current Registration Site (DECRS). Once successful, your firm’s name and information will appear with an expiration date of December 31, 2027, within 24 business hours.
To maintain your drug listing status for 2027, FDA must receive notification that a firm’s drug listing information:
01
Is certified as accurate, with no changes since the previous update
02
Has been updated during the 2026 calendar year
03
Will be de-listed because manufacturing and distribution have ceased
Submit a “Blanket No Changes Certification of Product Listing” in CDER Direct
1
Go to Product Listing & Certification.
2
Click “Create New/Upload File.”
3
Select the radio button to create a new product listing or certification using a blank form.
4
Select the document type “Blanket No Changes Certification of Product Listing.”
5
Tick the check box to auto-populate authorized agent details from your CDER Direct account.
6
Click “Add Labeler” and enter the labeler code of the product(s) you wish to certify.
7
Click “Refresh Establishments” to find all establishments involved with the labeler(s) products.
8
Select all establishments or specific ones. Selected establishments must not be expired or inactivated.
9
Select “Show Products,” then tick the products you wish to certify. Missing products can be added with “Add Product NDC.”
10
Click “Save.”
11
Submit SPL.
Using other applications
Create a “Blanket No Changes Certification of Product Listing SPL” document
1
Enter the authorized agent’s information.
2
Enter the labeler and establishment information.
3
Enter the product NDCs you wish to certify.
4
Submit.
Check your listing at the National Drug Code Directory. Once successful, the listing will appear with a certified-through date of December 31, 2027, within 24 business hours.
Contact mdi at info@mdiconsultants.com, RE: Registration 2027.