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FDA Registration Renewal timelines – when to renew your FDA registration.

11

Sep

2020

 

Generally, FDA registration renewal timelines are from October 1 to December 31 every year. However, the annual registration requirement may vary based on the product category.

Summary of FDA registration renewal requirements.

 

 

Food facility registration renewal timelines

 

  • Food facilities registration is required every even year between the 1st of October and December 31. For example, food facilities must renew their registration in the years 2020, 2022, 2024, and so on. Failure to timely renew your registration may result in the cancelation of the food facility registration. If food facility registration is not renewed by 11:59 PM on December 31, the registration is considered expired and will be removed from your account.

 

  • The FDA has abbreviated the biennial registration renewal process for a facility that has not had any changes to its registration information since the previous registration, registration renewal, or update for the facility.

 

  • However, for the year 2020 food facility registration renewal, a unique facility identifier (UFI) is required.

 

  • The Data Universal Numbering System D-U-N-S (DUNS) number is an acceptable UFI for the FDA. DUNS numbers are assigned and managed by Dun & Bradstreet.

 

 

  • A DUNS number can be obtained free of charge for D&B.

 

We offer US agent and food facility registration renewal assistance. If you need more information, please contact us.

  

Medical Device registration renewal timelines 

Medical device facility registration should be renewed every year between October 1 and December 31. Medical device facilities are also required to pay the FDA registration fee.  

 

The FDA fee for FY 2021 medical device registration is $ 5546. If you register/renew on or before October 1, your registration will remain valid until the end of the next calendar year.

 

We offer assistance for medical device registration and listing. Contact us for more information.

Drug establishment registration renewal.

 

Registrants of Drug Establishments are required to renew their facility registration between October 1and December 31. Also, facilities must update or submit the “no change” notification for active drug listings.

 

There is no FDA fee for drug establishment registration renewal.

 

 

We assist companies in registering and renewing drug establishment registration and updating drug listings.

 

During the annual registration renewal for food facility and drug establishment, the FDA will send an email to the US Agent to confirm if the appointed is US Agent has agreed to act as US Agent for their facility.

 

We can offer quick and cost-effective services for FDA registration and US Agent services. If you have any questions, please contact us.

 

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