Medical Device Annual Establishment Renewal
Annual FDA establishment registration renewal support for medical-device establishments required to register — including registration review, device-listing review, user-fee coordination, and U.S. Agent information review for foreign establishments.
What Is FDA Medical Device Annual Establishment Renewal & Who Must Renew?
FDA requires establishments that are subject to medical-device establishment registration under 21 CFR Part 807 to submit registration information annually. The annual review period is October 1 through December 31, even when no registration information has changed.
Most establishments that are required to register must also pay the annual establishment registration fee, but FDA's activity-based tables determine whether a particular establishment must register, list devices, and pay the fee. The requirement should therefore be based on what the establishment actually does rather than a blanket statement that every manufacturer, distributor, or device business has the same obligations.
- Annual registration information: October 1 through December 31.
- Device listing information is reviewed during the same annual period.
- For establishments required to pay, the FDA fee is paid before registration is completed.
- Foreign establishments that must register should keep their U.S. Agent information current.
- Registration and listing do not mean FDA approval, clearance, authorization, or certification.
Our Medical Device Annual Establishment Renewal Services
Complete annual renewal support covering registration review, device listing review, FDA user-fee coordination, and applicable U.S. Agent information.
Annual Registration Review & Renewal
We review the establishment's current FDA registration information and coordinate annual registration in FURLS/DRLM during the October 1 through December 31 renewal period.
Device Listing Review & Updates
We review applicable device listings during the annual registration cycle and coordinate updates where devices, listing information, establishment activities, or other listing details need to be changed.
FDA User Fee Coordination
For establishments required to pay the annual fee, we confirm the applicable fiscal-year amount and coordinate the payment workflow so the FDA PIN and PCN can be obtained and applied in FURLS/DRLM.
Registration & U.S. Agent Update Support
We help identify registration information that should be updated and review U.S. Agent information for applicable foreign establishments so the annual registration reflects current information.
FDA Medical Device Renewal Support for the New Fiscal Year
Supporting medical device companies worldwide with annual FDA registration, listing review, and renewal coordination.
FDA compliance support for companies across regulated industries.
International and U.S. companies supported with FDA regulatory requirements.
Established regulatory-support history for companies entering and operating in the U.S. market.
FDA annual registration and listing review period runs from October 1 through December 31.
How Our Medical Device Annual Renewal Service Works
A four-step process aligned with FDA's current payment, FURLS/DRLM, and annual listing-review workflow.
Review Registration & Listings
We collect your current establishment information, review known changes, check applicable device listings, and confirm U.S. Agent information for foreign establishments where required.
Coordinate FDA Fee Payment
When the establishment is required to pay the annual fee, payment is completed through FDA's Device Facility User Fee system so the PIN and PCN can be issued after processing.
Complete Annual Registration
The PIN and PCN are applied in FURLS/DRLM and the annual establishment registration information is submitted during the October 1 through December 31 window.
Confirm Listings & Completion
Applicable device listings are reviewed and updated as needed, and we confirm completion of the annual registration workflow within the agreed service scope.
What to Know Before the FY2027 Renewal Window Opens
The next annual renewal period starts October 1, 2026.
Review establishment information, device listings, ownership/activity changes, and foreign U.S. Agent information. Prepare the FDA fee payment so there is time for processing.
Complete FY2027 annual registration and review listing information. FDA's FY2027 annual establishment registration fee is $13,785 for establishments required to pay.
Continue to update registration and listing information when applicable changes occur instead of waiting until the next annual renewal cycle.
Complete FDA Medical Device Compliance Solutions
Explore related FDA medical device registration, listing, labeling, U.S. Agent, quality-system, and import compliance services.
Medical Device Establishment Registration
Initial FDA establishment registration support for applicable domestic and foreign medical-device establishments.
Medical Device Listing
Device listing support with product-code and classification review for applicable devices linked to registered establishments.
Medical Device Labeling & Product Review
Review device labels, packaging, IFU, UDI/GUDID considerations, and applicable FDA labeling requirements.
Medical Device DUNS Request Assistance
DUNS request and verification support for FDA medical-device registration, GUDID, and related CDRH workflows.
Medical Device U.S. Agent Services
Annual U.S. Agent representation for applicable foreign medical-device establishments and FDA communications.
Medical Device Listing Certificate
Professional verification documentation prepared from applicable FDA registration and listing records; not FDA-issued.
QMSR / cGMP Support
QMSR gap assessments, ISO 13485 alignment, quality documentation, CAPA, and FDA inspection-readiness support.
Medical Device Annual Establishment Renewal
Annual registration review, FDA user-fee coordination, device-listing review, and renewal support for the new fiscal year.
Import Alert & Device Detention Resolution
Case-specific support for FDA medical-device detentions, Import Alerts, corrective actions, and entry-compliance matters.
Laser Accession Report & Submission
Prepare the FDA Laser Product Report / Radiation Safety Product Report, coordinate CDRH submission, and follow the accession number for applicable laser products.
Frequently Asked Questions — Medical Device Annual Establishment Renewal
Current answers covering the renewal window, FY2027 fee, PIN/PCN workflow, listing review, U.S. Agents, small-business waivers, and annual registration requirements.
What is FDA Medical Device Annual Establishment Renewal?
Medical device establishments that are required to register with FDA must submit annual registration information each fiscal year. FDA requires annual registration information to be submitted between October 1 and December 31, even when no registration information has changed.
When is the annual medical device registration renewal window?
FDA's annual registration window runs from October 1 through December 31. Listing information must also be reviewed during that same period and updated when needed.
What FDA establishment registration fee applies to the upcoming FY2027 renewal?
For FY2027, which runs from October 1, 2026 through September 30, 2027, FDA has set the annual medical device establishment registration fee at $13,785. The FY2026 fee of $11,423 remains in effect only through September 30, 2026.
Does every medical device establishment have to pay the annual registration fee?
No. FDA's activity table determines which establishment types must register, list, and pay the fee. Most establishments required to register must pay the annual establishment registration fee, but the exact obligation depends on the activity performed at the establishment.
Can a small business receive a reduced annual establishment registration fee?
The establishment registration fee does not have a reduced small-business rate. FDA may grant a waiver of the annual registration fee, excluding initial registration, to certain qualified small businesses with gross receipts or sales of no more than $1 million that meet FDA's financial-hardship and prior-payment criteria.
Who must renew FDA medical device establishment registration annually?
Establishments that are required to register under 21 CFR Part 807 must complete annual registration. FDA's activity-based tables identify which domestic and foreign manufacturers, contract manufacturers, sterilizers, specification developers, relabelers, repackagers, initial importers, and other establishment types must register, list, and pay the fee.
Must device listings be reviewed during annual renewal?
Yes. FDA states that listing information must be reviewed each year between October 1 and December 31 at the same time the establishment reviews its registration information. Updates should be submitted when needed.
Do I have to pay the FDA user fee before completing annual registration?
Yes, for establishments required to pay the fee. FDA instructs establishments to pay through the Device Facility User Fee system first. After payment processing, FDA provides a Payment Identification Number (PIN) and Payment Confirmation Number (PCN), which are then applied in FURLS/DRLM to complete registration.
How long does it take to receive the PIN and PCN after payment?
FDA states that payment processing and issuance of the PIN and PCN typically takes several days, so the user fee should be paid in advance of the date you need to complete registration.
Can a foreign establishment renew without a U.S. Agent?
Foreign medical device establishments that are required to register must designate a U.S. Agent. The U.S. Agent information should remain current in the establishment's registration, and it should be reviewed as part of the annual registration process.
What information should be reviewed during renewal?
The annual review should confirm the establishment's current registration information and applicable device listings. Depending on the establishment, this can include company and facility information, establishment activities, official correspondent information, U.S. Agent information for foreign establishments, and listed devices.
What if my establishment information changed before the annual renewal window?
Do not wait for annual renewal when FDA requires a mid-year update. Registration and listing information should be updated when applicable changes occur, and the annual October 1 through December 31 review should then confirm the information remains current.
What happens if annual registration is not completed by December 31?
The establishment will not have completed the annual registration required for that fiscal year. This can create registration and import-compliance problems. The exact consequence depends on the establishment and products involved, so this page does not promise or imply that every late renewal automatically produces the same enforcement outcome.
Does annual registration mean FDA has approved my establishment or devices?
No. FDA states that registration and listing do not denote FDA approval, clearance, authorization, or certification of the establishment or its devices.
Can FDA Registration Assistance manage both renewal and device listing updates?
Yes. Our annual renewal service can include registration review, coordination of the applicable establishment fee, FURLS/DRLM renewal support, review of linked device listings, and coordination of necessary updates within the agreed service scope.
How do I start my annual renewal with FDA Registration Assistance?
Send us your establishment name, FDA registration number if available, country, current U.S. Agent information if applicable, and any known registration or listing changes. We will review the scope, confirm the applicable professional and FDA fees, and coordinate the renewal process.
Start Your Medical Device Annual Establishment Renewal
Send your establishment details and we will review the renewal scope, applicable FDA fee, registration information, device listings, and U.S. Agent details where applicable.
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