FDA registration renewal season opens on October 1, 2026 and closes on December 31, 2026. Miss it, and your establishment is treated as unregistered on January 1 — shipments can be refused at the port, and your record can disappear from FDA's public database. 2026 is also an even-numbered year, which means food facilities and drug, device and cosmetic establishments all have obligations in the same 92-day window.
Here is exactly who has to renew this cycle, what it costs, and the steps that most often go wrong.
The 2026 FDA renewal window at a glance
FDA establishment registrations expire on a fixed calendar date, not on the anniversary of your original filing. The window is identical for every facility in a category, so there is no personal deadline to look up for most registration types.
| Registration type | Frequency | Due in 2026? | FDA fee |
|---|---|---|---|
| Medical device establishment | Annual (Oct 1 – Dec 31) | Yes | $13,785 (FY2027) |
| Drug establishment + drug listing | Annual (Oct 1 – Dec 31) | Yes | No filing fee |
| Food facility | Biennial, even years (Oct 1 – Dec 31) | Yes | No fee |
| Cosmetic facility (MoCRA) | Biennial, from your own registration date | Depends on your date | No fee |
| Self-identification (GDUFA) | Annual (May 1 – Jun 1) | Next cycle | Facility fees apply |
| Drug Master File (DMF) | Annual, on submission anniversary | Varies | DMF fee |
A full breakdown of renewal periods, validity dates and filing methods by product type is maintained on the FDA registration renewal page.
Medical device establishments: the FY2027 fee jumped 20.7%
Device establishment registration renews every year, and the user fee must clear before the registration can be submitted. For fiscal year 2027 — which covers the October 1, 2026 to December 31, 2026 renewal window — FDA set the annual establishment registration fee at $13,785, up from $11,423 in FY2026. That is a $2,362 increase, or 20.7%.
Two points catch people out every year:
- There is no small business discount on this fee. Unlike 510(k) and PMA fees, the establishment registration fee is the same for a two-person contract manufacturer and a multinational.
- Payment and registration are separate steps. You pay first, then use the Payment Identification Number (PIN) and Payment Confirmation Number (PCN) to complete the registration in FDA's Device Registration and Listing Module. Paying the fee alone does not renew anything.
Device listings also have to be reviewed and updated during the same window. An active registration attached to a stale listing is an incomplete renewal.
Drug establishments: registration and listing
Drug establishment registration renews annually between October 1 and December 31 via SPL submission through FDA's Electronic Submissions Gateway. There is no separate filing fee, although generic and OTC monograph facilities owe GDUFA or OMUFA facility fees under different programs.
The step most often skipped is the listing. During each renewal you must either submit an updated drug listing or file a blanket no-change certification confirming that nothing about your listed products has changed. Skip it and the listing data is flagged as uncertified, even though the registration itself went through.
Food facilities: 2026 is a biennial renewal year
Food facility registration renews only in even-numbered years, which makes 2026 a mandatory cycle. The window runs from 12:01 a.m. on October 1, 2026 to 11:59 p.m. on December 31, 2026. There is no FDA fee.
Requirements to have ready before you start:
- A Unique Facility Identifier — FDA accepts the D-U-N-S number, and it must match the facility name and address exactly.
- Working FDA Industry Systems account credentials for the account owner.
- US Agent confirmation for foreign facilities.
Per FDA, a registration not renewed by December 31 is considered expired and is removed from your account. There is no grace period and no late renewal — you file again as a brand-new registration, and the original number is not always restored.
Cosmetic facilities: your MoCRA date is not everyone else's
This is the biggest misconception of the 2026 season. Cosmetic facility registration under MoCRA renews biennially from the date you registered or last renewed — not during the October–December window. A facility that registered in June 2025 is due in June 2027, regardless of what the rest of the industry is doing this quarter.
What is annual for cosmetics is the product listing, which has to be kept current every year even while the facility registration sits on a two-year clock.
Foreign facilities: the US Agent step that quietly kills renewals
A US Agent is mandatory for every foreign facility registered with FDA. During renewal, FDA emails the named agent for confirmation. If the agent does not respond, the renewal simply does not complete — no rejection notice, no second attempt.
A large share of lapsed foreign registrations trace back to an agent who changed their email, stopped providing the service, or never agreed to act in the first place. Verify your agent will respond before October 1, not after your submission stalls in December.
What happens if you miss December 31
An expired registration is treated as no registration at all from January 1 onward:
- FDA may remove the establishment and listing records from its public database.
- Products from an unregistered facility can be considered misbranded under the FD&C Act.
- Shipments may be refused at the port of entry, and the facility can be added to an import alert — which then requires a detention response and DWPE removal to resolve.
- Distributors, retailers and online marketplaces that verify registration status may suspend open purchase orders.
The commercial damage usually arrives before the regulatory damage does. A buyer asking for proof of registration in February is a much more common trigger than an FDA letter.
A seven-point FDA renewal checklist
- List every obligation you hold. One company often carries an establishment registration, a product listing and a self-identification at once. Renewing only the establishment leaves the record incomplete.
- Recover account access now. If the person who created the FDA account has left the company, account recovery has to be requested from FDA — and that takes weeks, not days.
- Pay the device user fee early. Payment must clear before the registration can be submitted.
- Verify the establishment record. Address, owner/operator, official correspondent, trade names and US Agent. An outdated address is the single most common reason a renewal is rejected.
- Update or certify the product listing. Device listings reviewed, drug listings updated or blanket-certified, cosmetic listings refreshed annually.
- Submit through the correct system. Food and cosmetic facilities through the FDA account; drug establishments via SPL through the ESG; device establishments through the registration and listing module once the fee clears.
- Keep documented proof. FDA does not issue a renewal certificate of any kind, so keep your confirmation records — buyers, customs brokers and marketplaces will ask.
Frequently asked questions
When does FDA registration renewal open in 2026?
October 1, 2026. It closes December 31, 2026 at 11:59 p.m.
Does FDA send a reminder before the deadline?
Not reliably. FDA may email the official correspondent on file, but if that address is outdated — which it often is — nothing arrives. The deadline is your responsibility to track.
Does FDA issue a registration renewal certificate?
No. FDA does not issue certificates of registration or renewal for any product category. Any certificate you hold was issued by a third party, not by FDA.
Can I renew after December 31?
No. The registration expires and must be filed again as a new registration. There is no late window.
How much is the FDA device registration fee for the 2026 renewal?
$13,785 for fiscal year 2027, with no small business reduction.
Get your 2026 renewal filed
The window closes December 31, and FDA account problems are the one thing you cannot fix at the last minute. Liberty Management Group has handled FDA registrations since 2009 and files renewals for drug, device, food and cosmetic establishments — including US Agent service for facilities in more than 150 countries, with food facility renewals typically completed within one business day.
→ Start your FDA registration renewal
Sources: FDA MDUFA fee rates, FDA food facility biennial renewal user guide, FDA cosmetic registration and listing. Fee figures reflect fiscal year 2027 rates published by FDA.
