How to Renew FDA Registration? FDA Renewal Steps by Step Guide

The FDA registration renewal process differs depending on the products category. Below, we break down the FDA renewal steps and requirements for 1) food and supplements, 2) cosmetics, 3) drugs and 4) medical devices industries.

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 2023, it needs to be renewed at the end of 2024, 2026, and so on. In short, the steps are:

Access the FDA registration number and PIN

Access the 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 access to your FDA number and the PIN code prior to the FDA renewal. The FDA usually sends renewal notices to the registered food facilities during the renewal period, October 1 and December 31. If you have questions regarding your FDA FURLS account, contact the 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, no fee is 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.

Please call or email us if you need assistance renewing your food facility registration. Upon completion of the registration renewal, a certificate of FDA registration will be issued as proof.

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 it biennially. Every firm required to register as a cosmetic facility must renew its registration, and the due date is the biennial anniversary of the initial facility registration submission. For example, if the initial Facility Registration was 2024-July-01, then the biennial due date would be 2026-July-01 and every two years thereafter.

Furthermore, all cosmetic product listings must be updated annually between October 1 and December 31 by 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 the FDA renewal of your cosmetic facility and products within the FDA’s MoCRA program or need a cosmetic product label review for FDA compliance, you may reach us via phone or email.

Drug Establishment Registration Renewal & Drug Listing Certification

FDA Drug establishment registration renewal must be submitted every year between October 1 and 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 FDA Drug establishment renewal does not automatically mean the drug listings associated with the establishment will also be renewed. The FDA drug listing renewal (NDC certification) can be submitted in SPL format via FDA portals, ESG, or CDER Direct. During the certification period, October 1 through December 31 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 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.

Call or email us if you need assistance renewing your drug establishment registration and drug listings. Upon completion of the registration renewal, a certificate of FDA registration will be issued as proof.

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

Remember that the FDA allows only one FURLS account per device establishment, which means you need access to the original FDA account login credentials 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, contact the official FDA at [email protected].

Please call or email us if you need assistance renewing your medical device establishment registration. Upon completion of the registration renewal, a certificate of FDA registration will be issued as proof.

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