FDA Registration Renewal

FDA registration renewal periods differ by product type. Drug and medical device establishments renew annually between October 1 and December 31. Food facilities renew biennially during even-numbered years. LMG manages all renewal types.

All Product TypesAnnual & BiennialFree Renewal CertificateSince 2009

FDA Registration Renewal — FDA Renewal Validity

FDA registration renewal period is different for each type of registration. The renewal period and validity are as follows:

Drug Establishments: Must renew annually between October 1st and December 31st. Registration valid until December 31st of the following year. Drug listing update or blanket no-change certification must also be submitted during renewal.

Medical Device Establishments: Must renew annually between October 1st and December 31st. Device listing must be reviewed and updated during the renewal period.

Food Facilities: Must renew between October 1st and December 31st of every even-numbered year (once every two years). There is no FDA fee for food facility registration renewal. As your US Agent, LMG can complete food facility renewal within one business day.

Cosmetic Facilities (MoCRA): Must renew biennially and update the product listing annually.

FDA will not issue any registration renewal certificate. LMG will issue a registration renewal certificate as proof of FDA registration renewal. If you did not complete renewal on time, FDA may remove your registration information and consider your products misbranded.

Drug & Medical Device: Renew annually October 1 – December 31
Food Facilities: Renew October 1 – December 31 of even-numbered years only
Cosmetic Facilities: Renew biennially, update product listing annually
US Agent is not required for domestic facilities but mandatory for foreign facilities
LMG issues a free renewal certificate upon completing any renewal

The table below provides the registration renewal period and its validity. It is your responsibility to ensure your registration remains valid and active. If you do not complete renewal on time, the FDA may remove your registration and listing information from its database, and your products may be considered misbranded. If you need assistance with FDA renewal, please get in touch with us. After we successfully renew your establishment, we will issue a free certificate of FDA registration for your records.

Type of FDA Renewal	FDA Renewal Period	FDA Renewal Validity	How to Renew FDA Registration
FDA Food facility registration renewal	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
FDA Drug establishment registration renewal	Annual – October 1st to December 31	One year – valid up to December 31st of next year	SPL submission via FDA ESG
FDA Drug Listing renewal	Annual – October 1st to December 31	1 year – valid up to December 31st of next year	SPL submission via FDA ESG
FDA Self-identification renewal	Annual – May 1st to June 1st	One year – right up to May 31st of next year	SPL submission via FDA ESG
FDA Medical device establishment registration renewal	Annual – October 1st to December 31	One year – valid up to December 31st of next year	Online via FDA account
FDA DMF Submission renewal	Annual – on the anniversary date of the original submission	One year – valid up to the anniversary date	ECTD Submission
FDA Cosmetic registration renewal	Biennial	Two years	SPL submission via FDA ESG

FDA Renewal Services — All Product Categories

LMG manages FDA registration renewal for all product categories — drug, device, food, and cosmetics.

Drug Renewal

Complete renewal of your drug establishment registration along with an update to your drug listing. We handle the full submission through FDA systems, including a blanket no-change certification when your listed products have not changed since the last filing.

Device Renewal

Complete renewal of your medical device establishment registration together with a thorough review of your device listing. We confirm your listing is accurate and current and manage the renewal so your establishment stays active and inspection-ready.

Food Facility Renewal

Renewal of your FDA food facility registration, including U.S. Agent confirmation for foreign facilities. Acting as your U.S. Agent, we can typically complete the renewal in one business day so your registration never lapses.

Cosmetic Facility Renewal

Renewal of your cosmetic facility registration, paired with an update of your cosmetic product listings. We manage both the facility and product filings so your registration and listings remain complete, accurate, and compliant under MoCRA.

Frequently Asked Questions

Common questions about this FDA service.

When must FDA registration be renewed?

Renewal periods differ: Drug and Device establishments renew annually October 1–December 31. Food facilities renew biennially during October 1–December 31 of even-numbered years. Cosmetic facilities renew biennially.

What happens if renewal is not completed on time?

FDA may remove registration information from the FDA site and consider your products misbranded. Foreign manufacturers’ products may be detained at U.S. ports of entry.

Does FDA issue a renewal certificate?

No. FDA will not issue any registration renewal certificate. LMG issues a free renewal certificate as proof of completed FDA registration renewal.

Is a US Agent required for renewal?

US Agent is not required for domestic facilities but is a mandatory requirement for foreign facilities. The US Agent can complete the renewal on behalf of the foreign establishment.

How long does renewal take?

LMG can complete FDA food and Cosmetic facility registration renewals within one business day. Drug and device renewals typically take 1–3 business days.