Medical Device
Establishment Registration
Medical Device Establishment Registration is the annual FDA filing in which the owner or operator of a facility that manufactures, prepares, propagates, compounds, assembles, processes, repackages, relabels, or initially distributes a medical device for U.S. commerce identifies that establishment to the FDA and lists every device produced there. The requirement is set by Section 510 of the Federal Food, Drug, and Cosmetic Act and operationalized under 21 CFR Part 807, with annual user fees authorized by the Medical Device User Fee Amendments (MDUFA). Registration places your facility on record with the FDA, links it to the specific devices you market, and is the gatekeeper that permits your device to legally enter U.S. commerce, be lawfully imported, and be sold to U.S. customers. Without a current, paid registration and corresponding device listing, your devices are considered misbranded under 21 U.S.C. § 352(o) — exposing your shipments to detention and refusal at the border, your company to FDA warning letters and injunctions, and your products to delisting from U.S. distributors and online marketplaces.
Owners and operators of establishments that manufacture, assemble, or distribute medical devices intended for the U.S. market must register annually with the FDA under 21 CFR Part 807. FDA Registration Assistance handles the full Medical Device Establishment Registration process for foreign and domestic device companies — ensuring your facility remains registered, compliant, and legally authorized to market devices in the United States.
What Is Medical Device Establishment Registration & Who Must Register
Medical Device Establishment Registration is an annual FDA requirement under 21 CFR Part 807 for any owner or operator of an establishment involved in the manufacture, preparation, propagation, assembly, or distribution of medical devices intended for U.S. commerce. Both foreign and domestic establishments must register and pay the annual FDA user fee each fiscal year. Failure to register — or to renew on time — can result in enforcement action, import detention, or loss of authorization to market devices in the United States. FDA Registration Assistance handles the complete registration process on your behalf.
FDA Registration Assistance manages every step of your establishment registration — from preparing and submitting your initial registration to renewing it annually and keeping your device listings current. Our specialists ensure your establishment remains compliant with 21 CFR Part 807 and fully authorized to market medical devices in the United States.
- Required for all foreign & domestic device manufacturers
- Must be renewed every FDA fiscal year (Oct 1 – Dec 31)
- Annual FDA user fee of $11,423 applies (FY 2026)
- Device listing required at time of registration
- FDA Registration Assistance manages the full process
Our Medical Device Establishment Registration Services
Everything medical device manufacturers need to register and remain compliant with the FDA — from initial establishment registration and device listing to annual renewal and ongoing FDA compliance support, handled end-to-end by experienced FDA regulatory specialists.
Establishment Registration Filing
FDA Registration Assistance prepares and submits your FDA Medical Device Establishment Registration — ensuring your facility information, owner/operator details, and device activities are accurately filed in the FDA establishment database.
Device Listing Support
FDA Registration Assistance prepares and submits your medical device listing alongside your establishment registration — ensuring all devices manufactured or distributed at your facility are accurately listed with the FDA as required.
Annual Registration Renewal
FDA Registration Assistance manages your annual FDA Medical Device Establishment Registration renewal each fiscal year — ensuring timely renewal and continued compliance to avoid enforcement action or loss of marketing authorization.
Ongoing Compliance Support
FDA Registration Assistance provides year-round regulatory support — including registration updates, device listing amendments, compliance monitoring, and guidance on FDA Medical Device requirements to keep your establishment fully compliant.
Trusted FDA Medical Device Registration Specialists
Helping foreign and domestic medical device manufacturers meet FDA registration requirements — ensuring compliant, timely establishment registration year after year.
How Our Medical Device Establishment Registration Service Works
A simple four-step process to get your medical device establishment registered and compliant with FDA requirements.
Submit Your Establishment Details
Provide your facility name, address, ownership details, and device information. FDA Registration Assistance reviews your establishment profile and prepares your registration filing.
Registration Prepared & Reviewed
FDA Registration Assistance compiles all required establishment and device information, prepares your complete FDA registration filing, and conducts a compliance review before submission.
Registration Submitted to FDA
FDA Registration Assistance submits your completed establishment registration to the FDA — confirming your facility is on record and your devices are actively listed in the FDA device database.
Registered & Annually Renewed
FDA Registration Assistance confirms your registration is active and compliant, then manages annual renewal each fiscal year — keeping your establishment continuously registered and legally authorized to market devices in the U.S.
What a Registered Medical Device Establishment Must Do
Holding an active FDA establishment registration is not a one-time filing — it is an ongoing legal duty under 21 CFR Part 807. Each registered owner/operator must maintain, update, and prove these obligations year-round.
Submit Initial Registration Within 30 Days
Under 21 CFR § 807.22, an owner/operator must electronically submit its initial establishment registration through FURLS within 30 days of beginning to manufacture, assemble, or process a device intended for U.S. commerce — before the first commercial distribution.
Pay the Annual FDA User Fee
Pay the MDUFA annual establishment registration user fee ($11,423 for FY 2026) prior to submitting or renewing the registration. Under Section 510 and MDUFA V, the registration is not accepted by FDA until the user fee is paid and the Payment Identification Number (PIN) is linked to the establishment.
File a Device Listing for Every Product
Per 21 CFR § 807.25, list every device the establishment manufactures, repacks, relabels, or imports — by product code, proprietary name, and activities performed — and link each listing to the corresponding establishment registration in the DRLM system.
Renew Registration Each Fiscal Year
Renew the establishment registration annually between October 1 and December 31, as required by 21 CFR § 807.21. Failure to renew within this window causes the registration to lapse into inactive status, triggering misbranding exposure under 21 U.S.C. § 352(o).
Update Registration Within 30 Days of Changes
Notify FDA within 30 days of any material change to the registration — including change of address, change of owner/operator, change of U.S. Agent, or addition/removal of device activities — as required under 21 CFR § 807.26 to keep the establishment record accurate.
Designate & Maintain a U.S. Agent (Foreign Establishments)
Foreign establishments must designate a U.S. Agent who resides or maintains a place of business in the United States and is available to respond to the FDA during U.S. business hours, per 21 CFR § 807.40. Failure to maintain a valid U.S. Agent invalidates the foreign registration.
Comply with QSR / 21 CFR Part 820 Inspections
A registered establishment is subject to FDA inspection at any reasonable time under Section 704 of the FD&C Act and must operate in accordance with the Quality System Regulation (21 CFR Part 820) — covering design controls, document controls, production, CAPA, and complaint handling.
Maintain Accurate Labeling Per 21 CFR Part 801
Ensure each marketed device bears labeling that complies with 21 CFR Part 801 — including manufacturer name and address, intended use, adequate directions, and UDI requirements — and that labeling matches the registered establishment and device listing records.
Establishment Registration vs. Medical Device Listing
These two FDA requirements are filed together, use the same FURLS system, and are often spoken about interchangeably — but they are legally distinct obligations. Most companies need both.
| Establishment Registration | Medical Device Listing | |
|---|---|---|
| Who Designates It | The owner/operator of the physical facility identifies the establishment to FDA | The owner/operator identifies each individual device manufactured at the registered establishment |
| Who/What It Represents | Represents the physical establishment (facility, address, activities, owner/operator) | Represents the specific device(s) — by proprietary name, product code, and activity |
| Required By | FD&C Act § 510(b) and (i); 21 CFR § 807.20 | FD&C Act § 510(j); 21 CFR § 807.25 |
| Governing Regulation | 21 CFR Part 807, Subpart B (domestic) & Subpart E (foreign) | 21 CFR Part 807, Subpart B / Subpart D |
| Primary Function | Tells FDA where devices are made and who is responsible for the facility | Tells FDA what devices are made and their regulatory classification |
| Required For | Every facility producing or initially distributing a device for U.S. commerce; annual renewal Oct 1–Dec 31 | Every device introduced into U.S. commerce; must be updated whenever a device is added, removed, or materially changed |
Two separate obligations — both required. Medical Device Establishment Registration and Medical Device Listing are independent legal duties under 21 CFR Part 807. Registration identifies your facility; listing identifies your devices. You cannot legally market a device in the United States by filing one and skipping the other. Even a single-product, single-facility manufacturer must maintain both — and update each one independently whenever facts change. FDA Registration Assistance handles both filings together so that your establishment, owner/operator, U.S. Agent, and every device record stay synchronized and current in the FDA database.
Self-Filing Your Establishment Registration vs. Using FDA Registration Assistance
Filing your establishment registration yourself in FURLS is technically possible — but the failure modes are expensive. Here is an honest side-by-side.
| Self-Filing in FURLS | RecommendedFDA Registration Assistance | |
|---|---|---|
| Cost | $0 in service fees, but $11,423 mandatory FDA user fee is unavoidable either way | $849/year all-inclusive service fee; FDA user fee ($11,423) paid separately to FDA |
| Availability | Limited to your team's hours, time zone, and regulatory staffing capacity | Dedicated FDA regulatory specialists available year-round across global time zones |
| Domain-Specific Support | You interpret 21 CFR Part 807, product codes, activity codes, and U.S. Agent rules on your own | 15+ years' experience filing Part 807 registrations across 135+ countries — product code, owner/operator, and U.S. Agent setup handled for you |
| Risk of Failure | High — common errors include wrong product code, missing U.S. Agent, unpaid user fee linkage, mismatched DUNS, missed Oct 1–Dec 31 renewal window | Compliance-reviewed before submission; renewal calendar managed for you; near-zero risk of lapsed status or import detention |
| Confirmation & Handling | You receive and interpret the FEI, Owner/Operator, and Registration numbers yourself; you handle any FDA correspondence | FEI, Owner/Operator, and Registration numbers delivered to you with a plain-English summary; we field FDA correspondence on your behalf |
| Renewal & Update Tracking | You must remember the annual Oct 1–Dec 31 renewal and self-file every change (address, ownership, U.S. Agent, device updates) within 30 days | Annual renewal, mid-cycle updates (§ 807.26), device listing amendments, and U.S. Agent maintenance handled for you automatically |
Why most device companies choose a professional service. The FDA user fee is the same either way — it is the avoidable mistakes that get expensive. Wrong product codes, missing U.S. Agent designations, unpaid PINs, and missed renewal windows trigger import detentions, warning letters, and marketplace delisting that cost far more than the $849 service fee. FDA Registration Assistance compresses 21 CFR Part 807 into a single annual workflow so your devices stay legally marketable in the U.S. without you ever touching the FURLS portal.
Free FURLS Self-Filing vs. FDA Registration Assistance
FDA does not charge a separate "service" fee — anyone can create a FURLS account and self-file. Here is what that really costs in practice.
| Free FURLS Self-Filing | RecommendedFDA Registration Assistance | |
|---|---|---|
| Government Fee | $0 government fee for FURLS access — but the $11,423 MDUFA annual user fee is mandatory either way | $0 government fee for our service — the same $11,423 MDUFA user fee is paid directly to FDA |
| Pros | No service fee; full direct control of your FURLS account credentials | $849/year fixed cost; expert handling of Part 807, FEI/DUNS, U.S. Agent, device listing, renewals, and FDA correspondence |
| Cons | You must learn 21 CFR Part 807, product/activity codes, fee-payment workflow, and U.S. Agent rules; one missed renewal or wrong code can cause import refusal or marketplace delisting | A modest annual service fee — paid back many times over the first time a mis-filing would have caused a detained shipment, warning letter, or Amazon/Walmart suspension |
| Best For | Companies with in-house U.S. regulatory affairs staff who already handle FURLS, 510(k), and Part 820 filings as a routine workload | Foreign manufacturers, contract manufacturers, importers, and growing device companies that need certainty, audit-ready records, and a single point of accountability |
The "free" option is rarely free in practice. A lapsed registration, a missing U.S. Agent, or an unpaid PIN is enough to trigger an FDA Import Alert detention — and resolving that costs vastly more in delayed revenue, attorney time, and reinstatement work than the $849 service fee. FDA Registration Assistance converts an open-ended regulatory risk into a fixed, predictable annual line item.
Key Terms for FDA Medical Device Registration
Plain-English definitions of the regulatory terminology you'll encounter when registering and listing a medical device with the FDA.
The federal regulation that operationalizes FD&C Act § 510 and sets the procedures for establishment registration and device listing — including who registers, what is filed, the renewal window, and U.S. Agent rules.
FDA Unified Registration and Listing System — the FDA's online portal — and within it, the Device Registration and Listing Module used by device establishments to file registrations, listings, and amendments.
FDA Establishment Identifier — a unique identification number FDA assigns to each registered facility. Used in import filings, inspections, and FDA correspondence.
A unique identifier assigned by FDA to the parent owner or operator of one or more registered device establishments. One owner/operator can hold multiple establishment registrations.
The numeric identifier confirming an establishment's active annual registration with FDA. It is publicly searchable in the FDA Establishment Registration & Device Listing database.
The U.S.-resident contact required for every foreign medical device establishment under 21 CFR § 807.40. The U.S. Agent is FDA's primary communication channel for the foreign establishment.
The annual establishment registration user fee authorized by the Medical Device User Fee Amendments and paid to FDA. $11,423 for FY 2026; required before a registration is accepted.
Data Universal Numbering System identifier issued by Dun & Bradstreet. FDA uses the DUNS number to verify establishment identity and link the entity to its MDUFA user fee payment.
The separate filing under 21 CFR § 807.25 in which a registered establishment identifies each specific device it manufactures or distributes — by proprietary name, product code, and activity.
A three-letter FDA classification code assigned to each medical device product type. It determines the device's regulation, class (I/II/III), and premarket pathway.
A premarket submission demonstrating that a device is substantially equivalent to a legally marketed predicate device. Separate from — and usually in addition to — establishment registration for most Class II devices.
A statutory status applied to any device whose manufacturer's establishment is not registered or whose device is not properly listed. Misbranded devices may be detained at the U.S. border and subject to enforcement.
Common Causes of FDA Establishment Registration Failure
Most lapsed registrations, import refusals, and FDA warning letters trace back to the same small set of operational mistakes. Avoid these and your establishment stays continuously authorized to market devices in the U.S.
Missed October 1 – December 31 Renewal Window
Under 21 CFR § 807.21, registrations not renewed by December 31 each fiscal year lapse into inactive status. Once lapsed, devices are deemed misbranded and become subject to Import Alert detention until reinstated.
Unpaid or Mis-Linked MDUFA User Fee
FDA will not accept a registration until the $11,423 MDUFA user fee is paid and the Payment Identification Number (PIN) is correctly linked to the establishment in FURLS. A common error is paying the fee but failing to attach the PIN to the registration.
Missing or Unresponsive U.S. Agent
Foreign establishments without a valid U.S. Agent (21 CFR § 807.40), or whose U.S. Agent fails to acknowledge designation or respond to FDA inquiries, have their registrations invalidated and their devices flagged at U.S. ports.
Wrong Product Code or Device Activity
Selecting the wrong FDA product code, or mis-declaring activities (e.g., listing "manufacture" when only "specification developer" applies), causes device listings to be flagged for review, can mismatch the establishment to the wrong CFR classification, and may trigger compliance correspondence.
Invalid Physical Address (P.O. Boxes / Virtual Offices)
21 CFR Part 807 requires the registered address to be the actual location where the device activity occurs. Mailbox services, virtual offices, and P.O. Boxes routinely fail FDA verification and can trigger registration cancellation.
Failure to File Updates Within 30 Days
Under 21 CFR § 807.26, changes to address, owner/operator, U.S. Agent, or device activities must be submitted within 30 days. Outdated records are a leading driver of FDA Form 483 observations and 21 CFR Part 820 inspection findings.
Mismatched DUNS / Owner-Operator Records
FDA cross-checks the DUNS number against the owner/operator on file. Inconsistent legal entity names, DUNS mismatches, or duplicate owner/operator records block fee payment acceptance and stall the registration in FURLS.
Improper "FDA-Registered" or "FDA-Approved" Claims
Stating or implying that an establishment registration is an FDA approval or endorsement — including misuse of the FDA logo — violates 21 CFR § 807.39 and is a frequent cause of FDA warning letters and Amazon / Walmart listing removals.
Complete FDA Medical Device Registration Solutions
We offer a full range of FDA medical device registration and compliance services — from establishment registration and device listing to U.S. Agent services and annual renewals.
Medical Device Establishment Registration
Register your foreign or domestic medical device establishment with the FDA — required annually for all device manufacturers and distributors under 21 CFR Part 807.
Medical Device Listing
List your medical devices with the FDA alongside your establishment registration — required for all devices manufactured or distributed for the U.S. market.
Medical Device Labeling & Product Review
Ensure your medical device labels and product documentation meet FDA labeling requirements — reviewed by experienced FDA regulatory specialists.
Medical Device DUNS Request Assistance
Obtain your DUNS Number required for FDA Medical Device Establishment Registration — fast and accurate assistance to keep your registration on track.
Medical Device U.S. Agent Services
Designate FDA Registration Assistance as your official U.S. Agent — legally required for all foreign medical device establishments registering with the FDA.
Medical Device Listing Certificate
Obtain your official FDA Medical Device Listing Certificate confirming your device is registered and listed with the FDA — for clients, distributors, and partners worldwide.
QMS / cGMP Support
Establish and maintain your Quality Management System (QMS) and current Good Manufacturing Practices (cGMP) to meet FDA medical device quality requirements.
Medical Device Annual Establishment Renewal
Ensure your FDA Medical Device Establishment Registration is renewed on time every fiscal year — avoiding compliance gaps, enforcement risk, and marketing disruptions.
Import Alert & Device Detention Resolution
Get expert help resolving FDA medical device import alerts and detention notices — restoring your device's ability to enter U.S. commerce as quickly as possible.
Frequently Asked Questions — Medical Device Establishment Registration
Find answers to the most common questions about FDA Medical Device Establishment Registration, annual renewal requirements, and how FDA Registration Assistance helps device companies stay compliant.
What is FDA Medical Device Establishment Registration?
FDA Medical Device Establishment Registration is an annual requirement under 21 CFR Part 807 for owners and operators of establishments involved in the manufacture, assembly, or distribution of medical devices for the U.S. market. Registration ensures the FDA knows the location of device establishments and the devices produced there.
Who is required to register a medical device establishment?
Any owner or operator of a domestic or foreign establishment that manufactures, assembles, reprocesses, relabels, repacks, or distributes medical devices for use in the United States must register with the FDA annually. This includes device manufacturers, contract manufacturers, specification developers, repackagers, and initial distributors (importers).
How often must a medical device establishment registration be renewed?
Medical Device Establishment Registrations must be renewed every FDA fiscal year — between October 1 and December 31 of each year. Failure to renew on time can result in an inactive registration status, enforcement action, and inability to legally market or import medical devices in the United States.
What is the FDA Medical Device Establishment Registration fee for FY 2026?
The FDA Medical Device Establishment Registration user fee for Fiscal Year 2026 (October 1, 2025 – September 30, 2026) is $11,423. This fee must be paid annually by all non-exempt establishments. FDA Registration Assistance guides you through the fee payment process as part of the registration service.
What regulation governs Medical Device Establishment Registration?
Medical Device Establishment Registration is governed by 21 CFR Part 807 — Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. This regulation specifies who must register, the information required, renewal timelines, and the consequences of non-compliance.
Do foreign medical device manufacturers need to register with the FDA?
Yes. Foreign establishments that manufacture, prepare, propagate, compound, or process medical devices intended for import into the United States must register with the FDA annually under 21 CFR Part 807. Foreign establishments must also designate a U.S. Agent who resides or maintains a place of business in the United States.
Is a U.S. Agent required for foreign medical device manufacturers?
Yes. Foreign medical device establishments are required to designate a U.S. Agent as part of their FDA establishment registration under 21 CFR Part 807. The U.S. Agent must reside or maintain a place of business in the United States and serves as the primary point of contact between the foreign establishment and the FDA. FDA Registration Assistance can serve as your U.S. Agent.
What is medical device listing and how does it relate to registration?
Medical device listing is the process by which device manufacturers identify the devices they manufacture or distribute at their registered establishment. Device listing must be submitted to the FDA when a new device is introduced and updated when changes occur. Establishment registration and device listing are separate but interconnected requirements that must both be maintained to legally market devices in the U.S.
What happens if I fail to register or renew my medical device establishment?
Failure to register or renew your medical device establishment registration can result in FDA enforcement action, import detention of your devices at the U.S. border, warning letters, injunctions, and loss of authorization to market medical devices in the United States. FDA Registration Assistance ensures your registration is submitted and renewed on time every fiscal year.
Does FDA Medical Device Establishment Registration require a 510(k) clearance?
No. Establishment Registration is a separate FDA requirement from 510(k) clearance or premarket approval (PMA). Registration simply notifies the FDA of your facility's location and device activities. However, most Class II medical devices also require a 510(k) submission to demonstrate substantial equivalence before marketing, in addition to establishment registration. FDA Registration Assistance can assist with both requirements.
What is the difference between a Class I, Class II, and Class III medical device?
The FDA classifies medical devices into three classes based on the level of control necessary to ensure safety and effectiveness. Class I devices (e.g., bandages) are lowest risk and subject to general controls. Class II devices (e.g., infusion pumps) require general controls and special controls, typically including 510(k) clearance. Class III devices (e.g., pacemakers) are highest risk and require premarket approval (PMA). All three classes generally require establishment registration.
How does FDA Registration Assistance help with device establishment registration?
FDA Registration Assistance prepares and submits your complete FDA Medical Device Establishment Registration — including facility information, owner/operator details, device activities, and device listing. We manage the annual renewal process, monitor your registration status, and provide ongoing compliance support to keep your establishment registered and compliant year after year.
Can I update my establishment registration after submission?
Yes. If changes occur to your establishment information — such as a change of address, ownership, or device activities — you must update your registration with the FDA. Updates to device listings must also be submitted when new devices are introduced or when device information changes. FDA Registration Assistance manages registration updates and amendments on your behalf.
Is a small business fee waiver available for medical device registration?
In limited cases, qualifying small businesses may request a fee waiver under the FDA Small Business Determination (SBD) Program if they meet specific financial hardship criteria. However, this is not a standard reduced fee available to all small businesses. FDA Registration Assistance can advise you on whether you may qualify and assist with the application process.
How long does medical device establishment registration take?
FDA Medical Device Establishment Registration can typically be completed within a few business days when all required information is available. FDA Registration Assistance prepares your complete registration package efficiently — ensuring accurate, timely submission to meet FDA deadlines and avoid any disruption to your device marketing or import activities.
How do I get started with FDA Medical Device Establishment Registration?
Contact FDA Registration Assistance to begin your Medical Device Establishment Registration. Provide your facility name, address, ownership details, and information about the medical devices you manufacture or distribute. FDA Registration Assistance will prepare and submit your complete registration — and manage annual renewals to keep your establishment continuously compliant.
What does the $849 Medical Device Establishment Registration service fee include?
The $849 annual service fee is all-inclusive for one establishment and covers: preparation of your Part 807 establishment registration, FURLS / DRLM submission, owner/operator setup, DUNS verification support, device listing for your products, delivery of your FEI, Owner/Operator, and Registration numbers, U.S. Agent coordination if applicable, and management of the annual October 1 to December 31 renewal. The mandatory FDA MDUFA user fee of $11,423 (FY 2026) is paid separately and directly to FDA, bringing your total Year 1 outlay to $12,272 ($849 + $11,423). If you also need our Medical Device U.S. Agent service, it is purchased separately — ask us for current U.S. Agent pricing.
Can my U.S. Agent or owner/operator be a friend, distributor, or unrelated third party?
Technically yes, but it is rarely advisable. 21 CFR § 807.40 only requires that the U.S. Agent reside or maintain a place of business in the United States, be reachable during U.S. business hours, and not be a mailbox/answering service. So a friend, U.S.-based distributor, or unrelated third party can legally be named — but they become the FDA's primary point of contact and are obligated to forward FDA inquiries (including inspection requests and import questions) immediately. If they miss or mishandle a single FDA communication, your registration can be invalidated and your shipments detained. A professional U.S. Agent like FDA Registration Assistance accepts the legal handling obligation contractually and is available year-round.
What happens if my U.S. Agent doesn't respond to the FDA?
Your foreign establishment registration is treated as invalid in practice. Under 21 CFR § 807.40, the U.S. Agent is the FDA's required communication channel for a foreign establishment; if the Agent is unreachable or fails to respond, FDA can deem the registration non-compliant, issue an Import Alert against your devices, refuse entry at the port, and pursue enforcement against the foreign manufacturer. To fix it, you must promptly designate a new U.S. Agent in FURLS and update your registration. FDA Registration Assistance offers same-day U.S. Agent replacement to restore an active registration record.
How do I change the U.S. Agent or owner/operator on an existing FDA establishment registration?
You update it electronically in FURLS / DRLM, and you must do so within 30 days of the change under 21 CFR § 807.26. The steps: log into FURLS, open the establishment registration record, edit the U.S. Agent or Owner/Operator section, save and submit the amendment, then confirm that FDA's system has accepted the change and that a confirmation notice was issued. The MDUFA user fee is not re-charged for a mid-cycle U.S. Agent or owner/operator change — only for the annual renewal. FDA Registration Assistance handles the entire amendment, verifies acceptance, and delivers updated confirmation to you.
Do I still need FDA Medical Device Establishment Registration if I only sell on Amazon, Shopify, Walmart, or eBay?
Yes — your selling channel does not change the FDA requirement. If the product meets the FDA definition of a medical device under Section 201(h) of the FD&C Act and is offered for sale into U.S. commerce, the establishment that manufactures, packs, labels, or initially distributes it must register annually under 21 CFR Part 807. Amazon, Walmart Marketplace, and most major U.S. retailers verify FDA registration and device listing status before approving medical device listings, and routinely delist sellers whose registrations are inactive or whose device listing cannot be located in the FDA database.
Do I need to register if I only manufacture private-label or contract devices for another brand?
Yes. Contract manufacturers, specification developers, repackagers, and relabelers each independently meet the definition of a medical device establishment under 21 CFR § 807.20, regardless of whose brand is on the finished device. Each separate physical facility performing one of those activities must hold its own active FDA establishment registration and pay its own annual MDUFA user fee. The brand owner's separate registration does not cover yours, and FDA tracks each establishment as an independent regulated entity.
Can I use a residential address, virtual office, or P.O. Box as my registered establishment address?
No P.O. Boxes, and virtual or mailbox-only addresses will typically fail FDA address verification. 21 CFR Part 807 requires the registered establishment address to be the actual physical location where the regulated device activity — manufacturing, repacking, labeling, or initial distribution — takes place. A home address is acceptable only if the regulated activity genuinely occurs there. Mis-registering a non-physical address is one of the most frequent causes of registration cancellation, FDA Form 483 observations, and Import Alert listing for foreign establishments.
Does FDA Establishment Registration mean my medical device is FDA-approved or FDA-cleared?
No — and this is one of the most common misconceptions in the device industry. FDA Establishment Registration only confirms that your facility is on record with FDA and that your devices are listed; it is not an FDA approval, clearance, certification, or endorsement of the device itself. FDA explicitly prohibits using the phrases "FDA-registered," "FDA-approved," or the FDA logo on labels or marketing materials to imply endorsement (see 21 CFR § 807.39). Many Class II devices additionally need 510(k) clearance, and Class III devices typically need PMA approval before lawful U.S. marketing.
How can a buyer or customer verify that my Medical Device Establishment Registration is real and active?
Anyone can verify a U.S. medical device establishment registration in real time on the FDA's public Establishment Registration & Device Listing database at accessdata.fda.gov. The database is searchable by establishment name, FEI number, or owner/operator number, and it shows the active registration status, listed devices, registration year, and U.S. Agent (for foreign establishments). FDA Registration Assistance can provide your client, distributor, or marketplace with the exact FEI / Owner-Operator / Registration numbers needed to verify your record on demand.
How is FDA Medical Device Establishment Registration different from FDA Food Facility Registration?
They are two completely separate FDA programs under different statutes. Medical Device Establishment Registration is required under FD&C Act § 510 and 21 CFR Part 807 for device manufacturers and importers, renewed annually between October 1 and December 31, with a $11,423 MDUFA user fee for FY 2026. Food Facility Registration is required under FD&C Act § 415 and 21 CFR Part 1, Subpart H for food facilities, renewed biennially in even-numbered years, with no FDA user fee. A company that makes both a food product and a medical device must hold both registrations independently.
If my facility makes both medical devices and other FDA-regulated products, do I need multiple FDA registrations?
Yes. FDA registration programs are product-specific, not facility-specific. A single physical facility that manufactures a medical device, a drug, and a cosmetic must register separately under 21 CFR Part 807 (devices), 21 CFR Part 207 (drugs), and the MoCRA cosmetic facility registration framework — each with its own user fees, renewal cycles, and listing obligations. FDA Registration Assistance can manage all applicable registrations for a single facility under one coordinated workflow so the records stay synchronized.
Are any medical device establishments exempt from FDA registration or the user fee?
The registration requirement itself has very few exemptions — most owner/operators of device establishments must register. Specific user-fee exemptions and reduced-fee categories exist under MDUFA: e.g., licensed practitioners, government-owned establishments, certain veterinary device makers, and some Class I device manufacturers may qualify for exemption from the annual establishment user fee under 21 U.S.C. § 379j(d). Even exempt establishments must still file the annual electronic registration. FDA Registration Assistance can assess whether your facility qualifies before you pay.
How quickly can FDA Registration Assistance restore my registration if it has lapsed or been canceled?
In most cases, an actively lapsed FDA Medical Device Establishment Registration can be reinstated within a few business days once the MDUFA user fee is paid and corrected information is submitted through FURLS. Reinstatement involves paying the current fiscal year fee, correcting any inaccurate facility, U.S. Agent, or device data, resubmitting the registration and listing, and confirming receipt of an updated active status. If your devices are already on an FDA Import Alert because of the lapse, the timeline depends on Import Alert removal — FDA Registration Assistance offers Import Alert & Device Detention Resolution as a companion service.
Do I need to re-register if I move my manufacturing facility to a new address?
Yes — but it's an amendment, not a new registration. Under 21 CFR § 807.26, you must update your existing establishment registration in FURLS within 30 days of the address change. The FEI may change if the new physical location is materially different, and any device listings tied to the old address must be re-linked to the new establishment record. You do not pay a new MDUFA user fee mid-cycle for an address change; you continue under the current fiscal year's registration. FDA Registration Assistance handles the amendment, FEI alignment, and device listing transfer so there is no break in your active registered status.
Register Your Medical Device Establishment Today
Submit your facility and device details and FDA Registration Assistance will prepare and submit your complete FDA Medical Device Establishment Registration — ensuring your facility is accurately registered, your devices are properly listed, and your establishment remains compliant each fiscal year.
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