FDA Registration Renewal - FDA Renewal Validity
FDA registration renewal period is different for each type of registration; the below table provides the registration renewal period and its validity. It is your responsibility to make sure your registration is valid and active. If you did not complete registration on time, the FDA may remove registration and listing information from the FDA site and consider your products misbranded. If you need assistance with FDA renewal, please get in touch with us ; we will issue a free certificate of FDA registration after successfully renewing your establishment as proof of FDA registration renewal.
Type of FDA Renewal |
FDA Renewal Period |
FDA Renewal Validity |
How to Renew FDA Registration |
Biennial - October 1st to December 31, every even-numbered year |
Two years - valid up to December 31st of the next even-numbered year |
Online via FDA account |
|
Annual - October 1st to December 31 |
One year - valid up to December 31st of next year |
SPL submission via FDA ESG |
|
Annual - October 1st to December 31 |
1 year - valid up to December 31st of next year |
SPL submission via FDA ESG |
|
Annual - May 1st to June 1st |
One year - right up to May 31st of next year |
SPL submission via FDA ESG |
|
Annual - October 1st to December 31 |
One year - valid up to December 31st of next year |
Online via FDA account |
|
Annual - on the anniversary date of the original submission |
One year - valid up to the anniversary date |
ECTD Submission |
|
Biennial |
Two years |
SPL submission via FDA ESG |
FDA Registration Renewal - FAQ
No, you don’t need to renew each food product but must renew the food facility registration.
US FDA Agent is not required for a domestic facility, but for foreign facilities, US Agent is a mandatory requirement; either the facility owner or the US Agent can renew the registration.
There is no FDA fee for food facility registration; you can find LMG Fees for FDA registration renewal assistance and US Agent service at FDA Registration Renewal fees
As your US Agent, we can complete FDA registration renewal within one business day.
Yes, you must review and update (if any) each drug listing during the FDA renewal period. If there is no change in the drug listings, you can go with FDA blanket listing submission to renew all listings together.
No, there is no renewal of FDA 510k clearance, but the medical device establishment registration must be renewed annually during FDA renewal.
FDA will not issue any registration renewal certificate, but LMG will issue a registration renewal certificate as proof of FDA registration renewal.
Quick links
- FDA Drug Registration Renewal
- FDA Medical Device Renewal
- FDA Registration Certificate
- U.S. FDA Agent Requirements
- FDA Agent Services
- FDA Detention of Products
- FDA Registration & US Agent Fees
- FDA Medical Device Renewal Fees - 2020
- FDA Medical Device Renewal Fees - 2021
- FDA OTC Drug Facility Renewal Fees 2021
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