How to Renew FDA Registration – Timelines and Fees

 FDA registration renewal timelines?

fda registration renewal

 

The answer to this question depends on whether your product is Food, Medical Device, or Drug.

Food facility registration  renewal  

Food facility registration must be renewed every even year between 1st October to 31st Decemebr. For example, in 2018, 2020, and 2022.  We offer free assistance for food facility registration for our clients who have an active U.S Agent contract with our company. 

 

Are you looking for new food facility registration? complete the below form, and we will get you a registration number in less than two business days  

Online food facility registration form.

Existing food facility online registration renewal form

If you have a U.S Agent contract with our company, we will contact you during the renewal period and offer free assistance for food facility registration renewal. 

FDA does not charge a fee for food facility registration.

Drug establishment registration renewal  

Drug establishment registration must be renewed annually between 1st October to 31st December.  If you fail to renew drug establishment registration timely,  registration may be canceled.  FDA shall remove the expired facilities from the registration database. FDA does not charge a fee for drug establishment registration or renewal.

We can assist you with drug establishment registration renewal at the lowest fee. Please contact us for more information.

Medical Device Registration renewal 

Medical device registration must be renewed between  1st  October to 31st December every year. Medical device establishments are also required to pay FDA fees annually. Medical device fee is published every in the federal register.

We can assist you with your medical device registration and device listing renewal at the lowest fee.  Please contact us for more information.

Medical device establishments are required to pay the annual FDA fee during 1st October and 31st Decemebr every year. FDA fee for FY 2021 is $ 5546. There is no small business exemption for  FDA annual registration fee. 

 

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