FDA Registration Renewal Calendar: Every Deadline by Product Type

Q: What happens if I miss the FDA registration renewal deadline?

Missing a renewal deadline has different consequences depending on product type. For food facilities, your registration is marked inactive after December 31 and products may be refused at import. For drug and device establishments, failure to renew can result in warning letters, import alerts, and inability to commercially distribute products. Re-registration is possible but may take additional time and delay operations.

Q: Do I need to pay a fee to renew my FDA registration?

It depends on the product type. Food facility registration renewal is free — FDA does not charge a fee. Drug establishment registration requires payment of an annual establishment fee set by GDUFA or PDUFA (amounts change each fiscal year). Medical device establishment registration requires an annual registration fee (currently $7,653 for FY2026, subject to annual adjustment). Cosmetic facility registration under MoCRA is currently free.

Q: When does MoCRA cosmetic facility registration need to be renewed?

Under the Modernization of Cosmetics Regulation Act (MoCRA), facility registration is required biennially. The initial registration deadline was July 1, 2024 (later extended by FDA). The next renewal is expected by July 1, 2026. FDA will issue guidance on the specific renewal process and window as the deadline approaches.

Q: Can I renew my FDA registration early?

FDA's renewal systems typically open on October 1 for food, drug, and device registrations. You cannot submit a renewal before the system opens. However, you can and should prepare all required data in advance so you can submit on the first day the window opens. Assurentry sends preparation reminders 60 days before each renewal window.

Q: Do dietary supplement facilities have different renewal deadlines than food facilities?

No. Dietary supplement manufacturing facilities register under the same FDA food facility registration system and follow the same biennial renewal schedule: October 1 – December 31 of even-numbered years. However, dietary supplement facilities must also comply with 21 CFR Part 111 (cGMP) requirements, which are separate from the registration obligation.

Q: What information do I need to update during renewal?

During renewal you must verify and update all facility information including facility name and address, US Agent details (for foreign facilities), product categories, and contact information. For drug establishments, you must also update drug listing data including NDC numbers, labeling, and active ingredients. Any changes that occurred since the last registration must be reflected in the renewal submission.

Quick Answer

FDA registration renewal deadlines vary by product type. Food and dietary supplement facilities renew biennially (Oct 1 – Dec 31 of even years). Drug and medical device establishments renew annually (Oct 1 – Dec 31 every year). Cosmetic facilities under MoCRA renew biennially on a July cycle (next: July 2026). Missing any deadline can result in inactive registration, import refusal, warning letters, or inability to distribute products.

Overview: FDA Registration Renewal Deadlines

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FDA-regulated facilities must maintain current registrations to legally manufacture, process, or distribute products in the United States. However, renewal timing, frequency, and requirements differ significantly depending on whether you handle food, drugs, medical devices, cosmetics, or dietary supplements.

This guide consolidates every FDA registration renewal deadline into a single reference so you can plan ahead, prepare your data, and never miss a window. Each section links to the relevant Assurentry service page for hands-on renewal support.

Renewal Calendar by Product Type

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The table below summarizes renewal frequency, windows, fees, and regulatory authority for each FDA-regulated product category.

Product Category	Frequency	Renewal Window	Next Deadline	Fee	Authority
Food Facilities	Biennial	Oct 1 – Dec 31, even years	December 31, 2026	None	21 CFR Part 1, Subpart H
Drug Establishments	Annual	Oct 1 – Dec 31, every year	December 31, 2026	GDUFA/PDUFA fee (varies)	21 CFR Part 207
Medical Device Establishments	Annual	Oct 1 – Dec 31, every year	December 31, 2026	$7,653 (FY2026)	21 CFR Part 807
Cosmetic Facilities (MoCRA)	Biennial	Per FDA guidance (July cycle)	July 1, 2026	None (currently)	FD&C Act §607
Dietary Supplement Facilities	Biennial	Oct 1 – Dec 31, even years	December 31, 2026	None	21 CFR Part 1, Subpart H

Food Facility Registration Renewal

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Biennial Renewal

Oct 1 – Dec 31 of even-numbered years (2026, 2028, 2030…)

No FDA Fee

FDA does not charge a fee for food facility registration or renewal

Next: Dec 31, 2026

Registrations not renewed by this date become inactive

Under 21 CFR Part 1, Subpart H, all domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must maintain a current FDA registration. Registrations are renewed through the FDA FURLS system. Foreign facilities must also maintain a current US Agent designation as part of the renewal process.

The biennial renewal window opens October 1 and closes December 31. For 2026, all food facilities must renew between October 1, 2026 and December 31, 2026. Failure to renew results in the registration being marked inactive, which can cause import refusal for foreign facilities and regulatory action for domestic facilities.

Drug Establishment Registration Renewal

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Under 21 CFR Part 207, all drug establishment registrations must be renewed annually between October 1 and December 31. Unlike food facilities, drug registrations expire every year regardless of whether the year is even or odd.

Annual registration applies to domestic and foreign manufacturers, repackers, relabelers, and drug product salvagers. Registration is submitted through FDA's DRLS system using SPL (Structured Product Labeling) format. Drug listing information must also be updated during annual registration.

Annual establishment fees apply under GDUFA (Generic Drug User Fee Act) and PDUFA (Prescription Drug User Fee Act). Fee amounts are published each fiscal year by FDA and vary based on establishment type. Failure to pay required fees can result in FDA refusing to receive or review applications. See our drug registration service page for current fee schedules.

Medical Device Establishment Renewal

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Medical device establishment registration under 21 CFR Part 807 follows an annual renewal cycle: October 1 – December 31 every year. Both domestic and foreign device establishments must renew, and device listing information must be kept current throughout the year.

A significant distinction for device establishments is the annual registration fee. For FY2026, the FDA annual device establishment registration fee is $7,653 (subject to annual adjustment by FDA). The fee must be paid before the registration can be submitted. Small businesses may qualify for reduced fees under certain conditions.

See our medical device registration service page for complete guidance on annual registration and fee payment procedures.

Device Fee Reminder

The device establishment registration fee must be paid before you can submit the annual registration. FDA will not process registrations with outstanding fees. Plan to pay the fee in September so your registration can be submitted when the window opens October 1.

Cosmetic Facility Registration (MoCRA)

The Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022, introduced mandatory facility registration and product listing for cosmetic manufacturers. MoCRA facility registration operates on a biennial cycle distinct from the food/drug/device October–December window.

The initial MoCRA registration deadline was July 1, 2024 (FDA later extended this deadline). The next biennial renewal is expected by July 1, 2026. FDA will issue specific guidance on the renewal process as the date approaches.

Currently, FDA does not charge a fee for MoCRA facility registration. Product listing is also required and must be updated when new products are introduced or formulations change. See our MoCRA registration service page and MoCRA compliance hub for complete guidance.

Dietary Supplement Facility Renewal

Dietary supplement manufacturing, packing, and holding facilities register under the same FDA food facility registration system and follow the identical biennial renewal schedule: October 1 – December 31 of even-numbered years. There is no separate registration system for dietary supplement facilities.

However, dietary supplement facilities have additional compliance obligations beyond registration, including adherence to dietary supplement cGMP (21 CFR Part 111), proper labeling under DSHEA, and adverse event reporting. These requirements are ongoing and independent of the biennial registration renewal. See our dietary supplement registration service page for details.

Consequences of Missing Deadlines

Missing an FDA registration renewal deadline can have serious operational and regulatory consequences. The specific impact depends on the product category:

Food Facilities

Registration marked inactive in FDA systems
Products from the facility may be refused at import (foreign facilities)
FDA may take regulatory action against domestic facilities
Must re-register from scratch — not just renew

Drug Establishments

Loss of ability to commercially distribute drugs in the US
FDA warning letters and potential import alerts
Drug listing becomes inactive, affecting NDC numbers
May impact pending drug applications (ANDAs, NDAs)

Medical Device Establishments

Devices considered misbranded under FD&C Act §510
FDA may issue warning letters and import alerts
Inability to legally distribute devices in the US
Outstanding registration fees accrue and must be resolved

Cosmetic Facilities (MoCRA)

Products considered misbranded under MoCRA provisions
FDA enforcement actions including warning letters
Potential for product detention at import
MoCRA enforcement is expected to increase as FDA staffs up

Dietary Supplement Facilities

Same consequences as food facilities (inactive registration)
Products may be refused at import
Additional scrutiny on cGMP compliance (21 CFR Part 111)
May trigger FDA inspection

How to Prepare for Renewal

Proactive preparation ensures smooth renewal and avoids last-minute scrambles. Follow this timeline for each renewal window:

Renewal Preparation Checklist

60 days before: Verify all facility information (name, address, contact) is current

60 days before: Confirm US Agent details are accurate (foreign facilities)

45 days before: Update product categories and listing information

30 days before: Pay applicable fees (device establishments, drug user fees)

30 days before: Gather login credentials for FDA submission systems (FURLS, DRLS, CDRH)

Oct 1: Submit renewal on the first day the window opens

After submission: Save confirmation receipt and update compliance records

After submission: Set reminder for next renewal cycle

Tip: If your facility handles multiple product types (e.g., food and dietary supplements, or drugs and devices), you may have multiple registration obligations with different deadlines. Use our deadline calculator to see all applicable dates, or check your renewal status with our renewal checker tool.

Frequently Asked Questions

When is the FDA food facility registration renewal window?

FDA food facility registrations must be renewed biennially during October 1 through December 31 of even-numbered years. The next renewal periods are October 1 – December 31, 2026, and October 1 – December 31, 2028. Registrations not renewed during this window are considered expired.

What happens if I miss the FDA registration renewal deadline?

Consequences vary by product type. Food facility registrations become inactive. Drug and device establishments lose the ability to distribute products. Warning letters, import alerts, and import refusal may follow. Re-registration is possible but takes additional time.

Do I need to pay a fee to renew my FDA registration?

It depends on product type. Food and dietary supplement facility renewals are free. Drug establishments pay annual GDUFA/PDUFA establishment fees. Medical device establishments pay an annual registration fee ($7,653 for FY2026). MoCRA cosmetic registration is currently free.

Is FDA drug establishment registration truly annual?

Yes. Drug establishment registration must be renewed every year between October 1 and December 31 under 21 CFR Part 207. This applies to all domestic and foreign manufacturers, repackers, relabelers, and drug product salvagers.

When does MoCRA cosmetic facility registration need to be renewed?

MoCRA facility registration is biennial. The initial deadline was July 1, 2024 (extended by FDA). The next renewal is expected by July 1, 2026. FDA will issue guidance on the specific renewal process as the deadline approaches.

Can I renew my FDA registration early?

FDA renewal systems typically open on October 1. You cannot submit before the system opens. However, you should prepare all data in advance so you can submit on the first day. Assurentry sends preparation reminders 60 days before each window.

Do dietary supplement facilities have different renewal deadlines than food facilities?

No. Dietary supplement facilities register under the same food facility registration system and follow the same biennial schedule: October 1 – December 31 of even-numbered years. Additional cGMP requirements (21 CFR Part 111) are separate from the registration obligation.

What information do I need to update during renewal?

During renewal you must verify and update facility name, address, US Agent details (foreign facilities), product categories, and contact information. Drug establishments must also update drug listing data including NDC numbers, labeling, and active ingredients.

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