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How to Renew FDA Registration?
How to Renew FDA Registration? FDA Renewal Steps by Step Guide.
FDA registration renewal process primarily depends on the type of products that are being marketed in the US. Here we try to break down the FDA renewal steps and fees based on the registration type. In the article below, we cover the FDA renewal steps for food, medical device, drugs and cosmetics.
Food Facility Registration Renewal
All food facility registrations must be renewed every ‘even year’ between October 1st, and December 31st. Regardless of when a food facility was registered, such registration must be renewed at the end of the following year. For example, if the facility was registered at the end of 2019, it needs to be renewed at the end of 2020 and 2022, 2024, and so on. In short, the steps are:
- Access FDA registration number and PIN
- Access FDA FURLS account
- Review and submit the FDA renewal
- Receive the FDA renewal notification
The FDA food facility registration renewal can be submitted using the FDA FURLS account or via your FDA agent, who has access to the original registration record. Remember, an FDA food facility registration can be transferred between FDA FURLS accounts if the 11-digit FDA registration number and the PIN code are available. It is essential to have to access your FDA number and the PIN code prior to the FDA renewal. The FDA usually sends out a few renewal notices to the registered food facilities during the renewal period, October 1st, and December 31st. If you have questions regarding your FDA FURLS account, you may contact official FDA at [email protected].
The FDA food facility registration is instant, meaning once it is completed, you will receive a renewal confirmation, and you will be all set for another two years. Except for possible FDA US agent fees, there is no fee involved in the FDA food facility renewal. The FDA does not publish the FDA food facility registration data on any public database, and the FDA renewal notification is the only proof you will receive from the FDA.
If you need assistance renewing your food facility registration, you may reach us by phone at +1 929-376-7870 or email us at [email protected], and we will assist you. As proof, a certificate of FDA registration will be issued upon completion of the registration renewal.
FDA Medical Device Registration Renewal
Medical device establishment registration must be renewed annually between October 1st, and December 31st. The FDA Medical device establishment registration renewal involves paying the annual user fee. Once the FDA annual fee is paid, a payment confirmation number PCN will be sent to the applicant, which is needed to renew the medical device establishment. In short, the steps are:
- Pay the FDA annual device user fee
- Receive the FDA confirmation PCN
- Submit the FDA renewal via FURLS
- Receive the FDA renewal confirmation
Keep in mind FDA allows only one FURLS account per device establishment, which means you need to have access to the original FDA account login credentials to be able to renew your device registration. When the device registration is renewed, all associated devices listed under the registration will be automatically renewed, and the records will be published on the FDA device establishment database. The device registration renewal process can be completed within 3-5 days. If you have questions regarding your previous FDA device registration, you may contact official FDA at [email protected].
If you need assistance renewing your device establishment registration, you may contact us by phone at +1 929-376-7870 or email us at [email protected], and we will assist you. As proof, a certificate of FDA registration will be issued upon completion of the registration renewal.
Drug Establishment Registration Renewal & Drug Listing Certification
FDA Drug establishment registration renewal must be submitted every year between October 1 to December 31. FDA drug registration renewal (or no change notification) can be submitted in SPL format (Structured Product Labeling) via FDA portals, ESG, or CDER Direct. In short, the steps are:
- Access FDA ESG or CDER account
- Access the original registration SPL file
- Submit the renewal/ no change notification
- Receive the FDA renewal notification
Bear in mind the FDA Drug establishment renewal does not involve paying any fees at the time of renewal. However, if you are a manufacturer of a monographed OTC drug, you may be subject to the annual user fee payment under the Over-The-Counter Monograph Drug User Fee Program (OMUFA).
The Drug establishment renewal does not automatically mean the drug listings associated with the establishment will also be renewed. The FDA drug listing renewal, known as NDC certification, can be submitted in SPL format via FDA portals, ESG, or CDER Direct. During the certification period, October 1st, through December 31st each year, every active listing on file with the FDA that has not been updated within the current calendar year must be certified that no changes have occurred to remain active for the coming year. If you have questions regarding your FDA CDER account, you may contact the official FDA at [email protected].
Both drug establishment registration and drug listing certification are completed instantly, with no buffer time. Upon completion of drug establishment registration, the record will be updated on the FDA drug establishment database. Likewise, the drug listing certification will be reflected in the FDA NDC directory.
If you need assistance renewing your drug establishment registration and drug listings, you can reach us by phone at +1 929-376-7870 or email us at [email protected], and we will assist you. As proof, a certificate of FDA registration will be issued upon completion of the registration renewal.
Cosmetic Facility Registration & Cosmetic Product Listing Renewal
According to the recently enacted FDA’s Modernization of Cosmetics Regulation Act of 2022 – MoCRA, all registered cosmetic facilities, must promptly update any changes to their registration and renew their registration biennially, every ‘even year’, between October 1, and December 31. Furthermore, all Cosmetic product listings must be updated annually, between October 1 to December 31 via accessing the original registration and listing SPL files. In short, the steps are:
- Access FDA ESG or CDER account
- Access the original registration SPL file
- Submit the renewal/ no change notification
- Receive the FDA renewal notification
If you need assistance regarding FDA renewal of your cosmetic facility and products within FDA- MoCRA program and/or Cosmetic product label reviews, you may reach us via phone at +1 929-376-7870 or email us at [email protected] and we will assist you.