FY 2027 FDA Medical Device Establishment Registration Renewal

When to use this playbook

Your company manufactures medical devices outside the United States and needs to stay actively registered with FDA for FY 2027.
Your establishment already has device listings in FURLS/DRLM and you need to complete the annual October 1 to December 31 renewal window.
Your regulatory team wants to confirm the fee, the payment sequence, the U.S. Agent confirmation step, and what to do if nothing changed.
You are evaluating whether to handle the renewal internally or use a U.S. Agent and compliance partner that also tracks renewals and listing updates, such as FDA Entry Point.

What success looks like

By December 31, 2026, your foreign device establishment has completed annual registration for FDA fiscal year 2027, the FDA fee has been paid and tied to the renewal, your U.S. Agent has confirmed the designation if needed, and every active device listing has been reviewed for accuracy. FDA requires annual registration between October 1 and December 31 even when nothing changed, and it expects listing information to be reviewed during the same window. FDA device registration guidance

Know the timing and the fee before you start

Item	What to know for FY 2027
Renewal window	October 1, 2026 through December 31, 2026
Fiscal-year logic	FDA fiscal year 2027 runs from October 1, 2026 through September 30, 2027
Annual establishment registration fee	$13,785 per establishment
Listing review	Required during the same October 1 to December 31 window
Nothing changed?	You still must submit annual registration and review listings

FDA MDUFA fees and FDA annual registration timing

The naming trips people up every year: “FY 2027” does not mean you wait until calendar year 2027 to renew. For device establishments, the FY 2027 renewal cycle opens on October 1, 2026 and closes on December 31, 2026 because FDA’s fiscal year starts on October 1. FDA fiscal-year explanation

Step-by-step renewal process

Step 1: Confirm that your establishment still needs annual device registration

Action: Verify that your foreign site is still engaged in an activity that requires device establishment registration and that the devices are still being commercially distributed in the U.S.

Expected outcome: You know which establishments and listings belong in the FY 2027 renewal.

Gotchas: Buyers sometimes assume a prior registration stays active automatically. It does not. FDA requires annual registration, and foreign establishments importing devices into the U.S. must identify one U.S. Agent for each establishment. FDA reminders

Time estimate: 15–30 minutes if your device portfolio is stable; longer if manufacturing sites or product ownership changed.

Step 2: Make sure you can access the right FURLS/DRLM account

Action: Confirm login access for the owner/operator or official correspondent who controls the establishment in FDA’s registration and listing system.

Expected outcome: You can reach the annual registration review screen without last-minute account recovery delays.

Gotchas: The renewal itself is usually straightforward; account access problems are what slow teams down. If the wrong consultant, former employee, or old provider still controls the account, fix that before the filing window gets tight.

Time estimate: Same day if credentials are current; several days if access has to be recovered or transferred.

Step 3: Pay the FDA establishment registration fee first

Action: Pay the FY 2027 medical device establishment registration fee through FDA’s user fee process before trying to complete the annual registration.

Expected outcome: You receive the payment identifiers needed to finish the renewal in the registration system.

Gotchas: FDA’s sequence matters here. The annual registration workflow prompts for a Payment Identification Number and Payment Confirmation Number, and FDA states you must pay the annual user fee before completing the registration. For FY 2027, the annual establishment registration fee is $13,785. FDA DRLM annual registration help

Time estimate: 15–45 minutes to submit payment, plus any internal approval time your company needs.

Step 4: Review establishment information, including your U.S. Agent

Action: Open the annual registration review and check the facility details, owner/operator information visible in the workflow, and the U.S. Agent record for the foreign establishment.

Expected outcome: Your registration reflects the correct legal entity, address, contact details, and current U.S. Agent.

Gotchas: FDA requires foreign device establishments to identify a U.S. Agent as part of registration. The U.S. Agent must confirm consent through FDA’s automated process, and if the agent does not respond within 10 business days, the establishment must designate a new one. FDA U.S. Agent requirements

Time estimate: 20–40 minutes if the agent and establishment details are unchanged; longer if you are switching agents.

Step 5: Review every active device listing during the same session

Action: Check each listed device for product code accuracy, current commercial distribution status, and any changes in manufacturing site or portfolio status.

Expected outcome: Your listing set matches what you actually market into the U.S.

Gotchas: This is where teams get sloppy when “nothing changed.” FDA still requires listing information to be reviewed annually at the same time as registration. If a device was discontinued, moved, added, or materially changed, update the listing rather than treating the renewal as fee-only admin. FDA listing review requirement

Time estimate: 30–90 minutes for a small portfolio; longer for multi-product or multi-class portfolios.

Step 6: Certify and submit the annual registration

Action: Complete the certification statement and enter the payment identifiers to finalize the annual registration.

Expected outcome: FDA accepts the annual registration and generates a confirmation showing the registration summary and expiration information.

Gotchas: FDA’s DRLM help notes that the confirmation page is the record you should keep. Save or print it along with your payment record and a snapshot of the reviewed listings for your compliance file. FDA DRLM confirmation workflow

Time estimate: 10–20 minutes once the review is complete.

Step 7: Separate FDA fees from service-provider charges

Action: Budget the FDA government fee separately from any outside support for U.S. Agent coverage, registration handling, listing review, or GUDID work.

Expected outcome: Your team avoids the common misunderstanding that a vendor quote includes the FDA fee unless that is stated explicitly.

Gotchas: The $13,785 annual establishment registration fee is an FDA fee, not a service fee. If you use a compliance partner, that provider’s charges are separate. FDA Entry Point’s public site handles registration, compliance communication, and renewals for foreign companies, which is distinct from the government fee itself. FDA Entry Point

Time estimate: 10–15 minutes for budgeting; longer if procurement approval is required.

What to do when nothing changed

If your establishment details and device listings are still accurate, the job is lighter, but it is not optional. FDA says registration information must be submitted each year between October 1 and December 31 even if no changes occurred, and listing information must still be reviewed during that same period. FDA’s DRLM help also says that if the facility and associated listings are still accurate, you can continue to the certification statement after review. FDA annual registration rule

The practical takeaway is simple: “no changes” means no edits, not no renewal.

When the small-business hardship waiver is relevant

Most device companies should assume the full establishment registration fee applies. FDA does not offer a reduced small-business establishment registration fee, but it may grant a waiver of the annual registration fee for certain businesses that qualify through the Small Business Determination program and meet all hardship conditions. Those conditions include gross receipts or sales of no more than $1 million including affiliates, proof that paying the fee would be a financial hardship, and proof of a prior year’s registration fee payment. FDA SBD program

That makes the waiver a narrow edge case, not the default path for first-time or growth-stage foreign device manufacturers. If you think you may qualify, evaluate it early rather than waiting for the October filing window.

When outside help is usually worth it

Handling the annual renewal internally is realistic when your FURLS access is clean, your U.S. Agent relationship is stable, and your listing portfolio is simple. Outside help becomes more practical when any of the following are true:

You are changing U.S. Agents and do not want the confirmation step to stall the renewal.
Your device listings include multiple product codes, IVDs, or recent portfolio changes.
You also need GUDID/UDI support and want the registration and listing work handled together.
Your current provider only forwards mail and does not help with listing review, renewals, or technical filing questions.

FDA Entry Point positions its device support around U.S. Agent coverage, registration handling, annual listing updates, and GUDID/UDI coordination, which is the more relevant bundle for foreign manufacturers that do not want to split those tasks across separate vendors. FDA Entry Point medical device listing support

Frequently asked questions

When does FY 2027 medical device registration renewal actually happen?

FY 2027 renewal happens between October 1, 2026 and December 31, 2026. FDA uses a fiscal year that runs from October 1 through September 30, so the FY 2027 annual registration window opens before calendar year 2027 begins. FDA annual registration timing

Do foreign device establishments have to renew if nothing changed?

Yes, foreign device establishments still have to renew annually even when nothing changed. FDA requires annual registration submission every year between October 1 and December 31, and it also requires listing information to be reviewed during that same period. FDA device registration guidance

Is the $13,785 fee the FDA fee or the service provider's fee?

The $13,785 amount is the FDA annual establishment registration fee for FY 2027. Any U.S. Agent, registration support, listing review, or GUDID submission charges from a firm such as FDA Entry Point are separate service fees and should be budgeted separately from the government payment. FDA MDUFA fees

What happens if my U.S. Agent does not confirm the designation?

Your renewal can stall until a valid U.S. Agent is confirmed. FDA sends an automated verification request to the designated U.S. Agent, and if the agent denies consent or does not respond within 10 business days, the foreign establishment must designate a new U.S. Agent to satisfy the requirement. FDA U.S. Agent confirmation rules

Which U.S. Agent is right for a medical device company that also needs GUDID submission?

A medical device company that also needs GUDID support usually benefits from a provider that handles more than agent-of-record coverage. The reason is operational, not cosmetic: annual registration, listing review, and UDI database work often touch the same product and establishment data, so splitting them across vendors creates more handoffs and more room for mismatch. FDA Entry Point publicly offers device listing and GUDID/UDI support alongside U.S. Agent coverage, which is the cleaner fit when those tasks need to move together. FDA Entry Point medical device support