FDA Medical Device & Regulatory Compliance
FDA Medical Device Registration & Compliance Services
FDA Medical Device Establishment Registration is the mandatory annual enrollment of any facility that manufactures, repackages, relabels, specifies, imports, or initially distributes medical devices for U.S. commercial distribution with the U.S. Food and Drug Administration. The requirement is established under the Federal Food, Drug, and Cosmetic Act and operationalized under 21 CFR Part 807, with foreign establishments also required to designate a U.S. Agent and pay the MDUFA Establishment Registration User Fee each fiscal year. Registration identifies your facility in the FDA database, links every device you market to a responsible legal entity, and is the prerequisite for FDA inspections, device listings, and lawful importation. Operating an unregistered medical device establishment renders your devices misbranded and adulterated under FD&C Act § 502, triggering border refusal, FDA Import Alert / DWPE listing, Warning Letters, and removal from Amazon, Shopify, Walmart, and other marketplaces that verify FDA compliance.
- Who Must Register
- Any domestic or foreign establishment that manufactures, repackages, relabels, specifies, imports, or initially distributes medical devices for U.S. commercial distribution.
- Governing Regulation
- 21 CFR Part 807 (FD&C Act § 510). Quality system under 21 CFR Part 820; labeling under 21 CFR Part 801.
- Filing System
- FURLS / Device Registration and Listing Module (DRLM) — FDA's electronic submission portal.
- Key Requirement
- Foreign establishments must designate a U.S. Agent physically located in the United States; all establishments must hold a valid DUNS Number as the Unique Facility Identifier.
- Confirmation Issued
- FDA Establishment Identifier (FEI) and Owner/Operator Number — required on device listings, Prior Notice, and entry documentation.
- Renewal Cycle
- Annual — every October 1 through December 31 of each fiscal year, including MDUFA user fee payment.
- Special Requirement
- Every marketed device must be separately listed with FDA product code, classification, and (where applicable) 510(k) / PMA / De Novo number.
- Service Fee
- Custom quote based on facility type, number of devices, and U.S. Agent inclusion. FDA also charges an annual MDUFA Establishment Registration User Fee (FY2025: $9,280, set annually).
Expert FDA medical device establishment registration, device listing, U.S. Agent services, labeling compliance, QMS/cGMP support, and annual renewal for domestic and foreign medical device companies selling in the U.S.
Our Services
Complete FDA Medical Device Compliance Services
Navigating FDA medical device regulations is complex, time-consuming, and costly if done incorrectly. Whether you are a domestic manufacturer, foreign device company, or contract manufacturer, compliance with the U.S. Food and Drug Administration is mandatory before distributing medical devices in the United States.
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.
Get started →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.
Get started →Medical Device Labeling & Product Review
Ensure your medical device labels and product documentation meet FDA labeling requirements — reviewed by experienced FDA regulatory specialists.
Get started →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.
Get started →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.
Get started →Medical Device Listing Certificate
Obtain your official FDA Medical Device Listing Certificate confirming your device is registered and listed with the FDA.
Get started →QMS / cGMP Support
Establish and maintain your Quality Management System (QMS) and current Good Manufacturing Practices (cGMP) to meet FDA medical device quality requirements.
Get started →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.
Get started →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.
Get started →Do You Need Registration?
Who Is Required to Register a Medical Device Establishment?
Under 21 CFR Part 807, a wide range of medical device businesses are legally required to register their establishments with the FDA — regardless of company size or country of origin.
Why FDA Registration Assistance
The Trusted Choice for FDA Medical Device Compliance
⚡ Fast 24–48 Hour Turnaround
Most device establishment registrations and device listing submissions are completed within 24 to 48 hours.
✅ 100% Accurate Filings
Our expert team ensures every device listing, registration, and labeling submission is complete and error-free.
🌍 135+ Countries Served
We work with medical device companies across 135+ countries, with deep knowledge of foreign establishment compliance.
🔒 Transparent Pricing
Our service fee is straightforward with no hidden costs — you pay a simple flat fee and we handle every step.
📅 Renewal Tracking Included
We track your annual renewal deadlines so your device registration is never deactivated.
📞 Dedicated Regulatory Support
A dedicated regulatory expert is assigned to your account for FDA inspection support, QMS/cGMP guidance, and ongoing management.
🏆 15+ Years Experience
For 15+ years we have guided over 1,000 medical device companies through FDA registration with a proven track record.
🚀 End-to-End Compliance
From initial registration through device listing, U.S. Agent services, labeling, QMS support, and annual renewal — we handle everything.
Compliance Coverage
FDA Medical Device Regulations We Handle
All medical devices manufactured, distributed, or imported into the U.S. fall under FDA jurisdiction. Our team covers every regulation that affects your medical device business.
Simple Process
How FDA Medical Device Registration Works
Getting your medical device establishment registered with the FDA is straightforward when handled by experts.
Complete our short intake form with your establishment details, device activities, device classifications, and contact information.
Our regulatory experts review your submission, confirm device classifications, identify FDA product codes, and prepare your filings.
We submit your establishment registration and device listings directly via the FURLS portal. Most are confirmed within 24–48 hours.
You receive your FDA Device Establishment Registration Number. We monitor annual renewals and provide ongoing support.
Legal Authority
Statutory & Regulatory Basis for Medical Device Establishment Registration
Medical Device Establishment Registration is grounded in U.S. federal statute and FDA regulation.
Medical Device Amendments of 1976 (FD&C Act § 510)
The federal statute that first required all medical device establishments — domestic and foreign — to register annually with the FDA and to list every device they manufacture or distribute for U.S. commerce.
Read on FDA.gov →21 CFR Part 807
The Code of Federal Regulations that operationalizes device registration — covering who must register, U.S. Agent designation, annual registration and listing requirements, and foreign establishment obligations.
Read on eCFR →Medical Device User Fee Act (MDUFA)
The user-fee statute that authorizes the annual FDA Establishment Registration User Fee, currently under MDUFA V (FY2023–FY2027). Every registered device establishment must pay the fee each fiscal year.
Read on FDA.gov →Core Duties
Responsibilities of a Registered Medical Device Establishment
Every FDA-registered medical device establishment carries continuing legal obligations under 21 CFR Parts 807, 820, 801, and 803.
Compare
Establishment Registration vs Device Listing
Establishment Registration and Device Listing are two separate FDA requirements under 21 CFR Part 807 that are often confused.
| Feature | Establishment Registration | Device Listing |
|---|---|---|
| Who Designates It | The owner / operator of the establishment. | The registered establishment for each individual device. |
| Who It Represents | The legal entity and physical facility engaged in device activities. | The specific medical device product being marketed in U.S. commerce. |
| Required By | FD&C Act § 510 and 21 CFR § 807.20 — for every facility doing covered device activity. | FD&C Act § 510(j) and 21 CFR § 807.25 — for every device manufactured or distributed. |
| Governing Regulation | 21 CFR Part 807, Subpart B (Establishment Registration). | 21 CFR Part 807, Subpart B (Device Listing) plus 21 CFR Part 801 labeling rules. |
| Primary Function | Identifies the facility to the FDA and links it to inspections, MDUFA fees, and enforcement. | Identifies each device, its FDA product code, classification, and regulatory pathway. |
| Required For | Lawfully operating a U.S. medical device facility or shipping devices into the U.S. | Lawfully marketing a specific device — even if the establishment is already registered. |
Which one do you need? You need both. Establishment Registration tells the FDA your facility exists and what it does. Device Listing tells the FDA exactly which devices your facility is putting into U.S. commerce. A registered establishment with no device listings cannot lawfully market any device, and a device listing cannot exist without an active registration to attach it to. Each device must be separately listed with the correct FDA product code, regulation number, and (where applicable) 510(k), PMA, or De Novo number. Foreign establishments need both plus a U.S. Agent. Get all three in place before your first shipment crosses the U.S. border.
DIY Self-Filing vs FDA Registration Assistance
Medical device establishment registration can be filed directly through FURLS or completed with a professional regulatory service.
| Feature | DIY via FURLS | Recommended — FDA Registration Assistance |
|---|---|---|
| Cost | FDA MDUFA fee only ($9,280 FY2025), but the staff time required is substantial. | FDA MDUFA fee plus a custom-quoted flat service fee — no hidden charges. |
| Availability | Self-managed during business hours; no after-hours support for FDA contact. | Dedicated regulatory specialist available throughout the engagement and during inspections. |
| Domain-Specific Support | FURLS help articles only; no advice on product codes, classification, or device listing structure. | Expert guidance on FDA product codes, device classification, 510(k) / PMA / De Novo references, UDI, and labeling. |
| Risk of Failure | High — misclassification, wrong product code, missing UDI, or unresponsive U.S. Agent leads to rejection or deactivation. | Low — every submission is reviewed and validated before filing to prevent rejection or import alert. |
| Confirmation / Handling | You receive raw FDA confirmation; interpretation and follow-up are your responsibility. | We deliver your FEI, Owner/Operator Number, listing confirmations, and a clean compliance record file. |
| Renewal / Update Tracking | You must remember the Oct 1–Dec 31 window and the 30-day update rule. | Proactive deadline tracking and 30-day update filings included for the life of the engagement. |
Why most companies choose a professional service: the FDA does not forgive registration errors — a single wrong product code, an incorrect device class, or a missed October 1–December 31 renewal can deactivate the establishment, trigger an Import Alert, and stop every device shipment at the U.S. border. The MDUFA user fee is the same either way, so the only meaningful question is who carries the regulatory risk. Most medical device companies — especially foreign establishments and any company shipping Class II or Class III devices — choose a dedicated professional service to eliminate that risk.
Friend U.S. Agent vs Professional U.S. Agent
Foreign device establishments often consider naming a friend or unrelated U.S.-based contact as their U.S. Agent.
| Feature | Friend / Unrelated Contact | Recommended — FDA Registration Assistance U.S. Agent |
|---|---|---|
| Government Fee | $0 — the FDA does not charge a fee to designate a U.S. Agent. | $0 — the FDA does not charge a fee; a professional service fee applies for verified, monitored coverage. |
| Pros | No service cost; easy to set up if a friend or U.S.-based contact agrees. | Verified U.S. address, monitored FDA inbox, written acceptance, regulatory expertise, and audit-ready records. |
| Cons | Missed FDA emails, untracked calls, vacations, job changes, address changes, and no regulatory expertise — any of which can invalidate the registration. | Annual service fee. No operational downsides for a foreign device establishment. |
| Best For | Not recommended for any commercial foreign device establishment. | Every foreign medical device manufacturer, contract manufacturer, repacker, relabeler, or importer. |
The U.S. Agent role has no FDA government fee — the real cost is the risk. A missed FDA inspection email, an unanswered request for information, or a contact who has moved or retired can render the entire foreign establishment registration non-responsive, putting every device on hold at the U.S. border. A professional U.S. Agent provides verified, monitored, regulator-grade coverage.
Glossary
Glossary & Technical Terms
Key acronyms and regulatory terms used throughout FDA medical device establishment registration and post-market compliance.
The FDA's electronic portal where device establishments register, list devices, designate U.S. Agents, and submit annual renewals.
The unique number assigned by the FDA to every registered establishment. It is used to track inspections, listings, and enforcement history.
A unique 9-digit identifier issued by Dun & Bradstreet that the FDA requires as the Unique Facility Identifier for device registration.
A person or entity physically located in the U.S. designated by a foreign device establishment to serve as the FDA's domestic point of contact.
The user-fee statute that authorizes the FDA's annual Establishment Registration User Fee, currently MDUFA V (FY2023–FY2027).
The FDA quality system rule at 21 CFR Part 820 — amended effective February 2, 2026 to incorporate ISO 13485:2016 — covering design controls, CAPA, document control, and production controls.
The FDA submission required for most Class II devices, demonstrating substantial equivalence to a legally marketed predicate device.
The most stringent FDA review pathway, required for most Class III devices, demonstrating safety and effectiveness through scientific evidence.
An FDA pathway for novel, low-to-moderate risk devices that lack a predicate, allowing classification into Class I or II without a full PMA.
A unique alphanumeric identifier on device labels, submitted to the Global Unique Device Identification Database (GUDID) under 21 CFR Part 830.
The FDA post-market surveillance requirement under 21 CFR Part 803 for manufacturers, importers, and user facilities to report adverse events.
The FDA's former systematic inspection method for evaluating a manufacturer's QMS. Retired February 2, 2026, when the FDA adopted the updated inspection process under the QMSR.
Common Failures
Why FDA Medical Device Registrations Get Deactivated or Rejected
These are the most frequent failure modes that cause the FDA to deactivate, reject, or flag medical device establishment registrations.
Missed Annual Renewal Window
Failure to renew between October 1 and December 31 deactivates the registration on January 1. Devices arriving under a deactivated registration are automatically refused.
Unpaid MDUFA Registration Fee
The annual MDUFA Establishment Registration User Fee must be paid before the registration is accepted. An unpaid fee blocks the registration even if the FURLS submission is complete.
Non-Responsive U.S. Agent
If the designated U.S. Agent fails to confirm acceptance or fails to respond to FDA communications, the registration can be invalidated and the foreign establishment treated as non-compliant.
Wrong Product Code or Device Class
Listing the device under the wrong product code, regulation number, or class causes the listing to mismatch the device's actual regulatory pathway — triggering rejection or misbranding citations.
Missing 510(k) or PMA Reference
Class II devices marketed without the 510(k) number on the listing, or Class III devices without the PMA number, are treated as not legally marketed and subject to border refusal.
Failure to Update Within 30 Days
Any change to address, ownership, U.S. Agent, or activity must be reported to FURLS within 30 days. Missing this puts the registration out of compliance.
Missing or Incorrect UDI / GUDID
Most marketed devices must carry a compliant UDI and have data submitted to the GUDID. Missing or incorrect UDI records cause misbranding citations and Import Alert risk.
Unresolved Import Alert / DWPE
Establishments on an active Import Alert face automatic detention of every shipment until the alert is formally resolved with corrective action documentation accepted by the FDA.
Frequently Asked Questions
FDA Medical Device Registration — Common Questions Answered
Yes. Any domestic or foreign facility that manufactures, repackages, relabels, or imports medical devices for U.S. commercial distribution must register with the FDA under 21 CFR Part 807. This applies to manufacturers, contract manufacturers, specification developers, importers, and initial distributors regardless of company size or country of origin.
FDA medical device establishment registration is a mandatory requirement for any facility that manufactures, repackages, relabels, or imports medical devices sold in the U.S. Registration identifies your site in the FDA database and must be updated annually between October 1 and December 31.
Yes. All foreign medical device establishments registered with the FDA must designate a U.S. Agent who serves as the official FDA point of contact for communications, inspection notifications, and regulatory correspondence.
Device listing is the process of registering each device you intend to market in the U.S. with the FDA. Every registered establishment must list all devices it manufactures or distributes.
Medical devices are classified into three categories based on risk: Class I (low risk) subject to general controls; Class II (moderate risk) may require 510(k) clearance; Class III (high risk) requires Premarket Approval (PMA).
Yes. A DUNS number is required to complete FDA medical device establishment registration through the FURLS portal. We assist in obtaining and verifying your DUNS number quickly to prevent registration delays.
An FDA Import Alert means your device shipments will be automatically detained at U.S. ports of entry. To resolve it you must identify the root cause and submit corrective documentation to the FDA.
PMA is the FDA's most stringent review process, required for most Class III devices. It requires valid scientific evidence — typically clinical data — demonstrating that the device is safe and effective.
Yes. A Quality Management System compliant with FDA's QMSR (21 CFR Part 820) is required for most marketed devices. As of February 2, 2026, the QMSR incorporates ISO 13485:2016 by reference — so an ISO 13485-aligned QMS now maps directly to the FDA requirement. It covers design controls, CAPA, complaint handling, and production controls.
Annually between October 1 and December 31. Failure to renew results in a lapsed registration, subject to import holds, enforcement actions, and market removal.
Your products may be considered adulterated or misbranded under the FD&C Act. This can result in import refusals, Warning Letters, product seizure, or recall.
Yes, but regulatory mistakes are common and costly. Incorrect device classifications, missing product codes, or improperly formatted device listings can cause delays and FDA enforcement actions.
Typically 24–48 hours when the application is complete and accurate. Once approved you receive an FDA Establishment Identifier (FEI).
Most Class I devices are premarket exempt but still require establishment registration and device listing. They must comply with general controls including QSR, labeling, and post-market rules.
MDR is the FDA requirement under 21 CFR Part 803 for manufacturers, importers, and user facilities to report adverse events, serious injuries, device malfunctions, and deaths.
Yes. We review device labels, IFUs, and promotional materials under 21 CFR Part 801, including UDI requirements, and help you avoid misbranding violations before products reach the market.
Establishment registration confirmation, device listing records, device clearance (510(k), PMA, or De Novo), QMS procedures, device labeling files, performance/safety test data, and UDI records.
Yes. All imported devices must comply with FDA establishment registration, device listing, and applicable premarket requirements before legally entering U.S. commerce.
QSIT was the FDA's systematic method for evaluating a manufacturer's QMS during inspections. It was retired on February 2, 2026, when the QMSR took effect — the FDA now uses an updated inspection process aligned with ISO 13485. Preparation still centers on the same fundamentals: management controls, design controls, CAPA, and production controls.
Yes. Selling devices online does not exempt a company from FDA requirements. Any establishment manufacturing, repackaging, relabeling, or importing devices must be registered.
Facility legal name and address, DUNS number, owner/operator information, U.S. Agent details (for foreign facilities), establishment activity type, and a list of devices with FDA product codes and classification.
A Unique Device Identifier is required on most device labels and must be submitted to the FDA's GUDID. It identifies the device make, model, and production instance.
Yes. We track annual renewal deadlines, handle updates to registration and device listings, and ensure year-round compliance.
Labels must comply with 21 CFR Part 801 and include device name, manufacturer name and address, intended use, directions for use, and any warnings. Devices must also carry a UDI.
Yes. We perform root-cause review of the Import Alert, prepare response documentation, and submit corrective action evidence to the FDA on your behalf.
With 15+ years of FDA regulatory expertise, we provide end-to-end support — registration, device listing, labeling, U.S. Agent, QMS support, import alert resolution, and annual renewals — reducing submission errors and protecting U.S. market access.
Pricing is custom-quoted based on facility type, number of devices to list, U.S. Agent inclusion, and whether QMS or labeling review is required. Contact us for a tailored quote. The FDA also charges a separate annual MDUFA Establishment Registration User Fee (FY2025: $9,280, set annually).
Technically yes, but strongly discouraged. The U.S. Agent must be physically located in the United States and reachable by the FDA. A friend or relative who misses or misroutes an FDA contact can cause your registration to be flagged, your devices detained, or your establishment cited. A professional U.S. Agent provides 24/7 monitored coverage.
Non-response can invalidate your registration. Under 21 CFR Part 807, the U.S. Agent must be reachable and responsive. Failure can trigger Import Alerts, device detentions, and in serious cases, deregistration.
Update your establishment registration through the FDA FURLS portal. The new U.S. Agent must confirm the designation electronically before the change becomes effective, and the FDA must be notified without delay. We handle the entire transition — typically completed within 24–48 hours.
No — you need one establishment registration per facility, but every individual device must be separately listed under that registration with the FDA product code, classification, regulation number, and (if applicable) the 510(k), PMA, or De Novo number.
No — they are completely separate. Establishment registration tells the FDA your facility exists. 510(k) clearance is a premarket submission demonstrating substantial equivalence to a predicate device. You need both: registration to operate, and 510(k) (or PMA, or De Novo, or exemption) to legally market a specific device.
Yes, if you manufacture, import, repackage, or relabel the device. These platforms actively enforce FDA compliance and request proof of registration, device listing, and 510(k) where applicable. Selling an unregistered device can result in immediate listing removal and FDA enforcement.
Yes. Anyone can verify a U.S. medical device establishment registration through the FDA's public Establishment Registration & Device Listing database. Buyers, distributors, customs brokers, and platforms like Amazon routinely use it to confirm a supplier is legitimately registered.
A product is a medical device under FD&C Act Section 201(h) when it is intended to diagnose, cure, mitigate, treat, or prevent disease. General wellness products promote only general health without disease claims. Disease claims can reclassify a wellness product as a device — triggering full FDA registration, listing, and clearance obligations.
Generally no for limited personal use, but commercial import always requires registration. Research and investigational use requires an Investigational Device Exemption (IDE) under 21 CFR Part 812.
Yes. One establishment can be registered for multiple activity types — manufacturer, contract manufacturer, specification developer, repacker, relabeler, importer, and initial distributor. Each activity must be accurately declared.
Your registration becomes inactive on January 1. Devices arriving under an inactive registration are subject to refusal. Resuming activity requires re-registration plus payment of the current MDUFA user fee. There is no grace period.
No — and stating otherwise is a misbranding violation. Establishment registration only confirms your facility is known to the FDA. Marketing copy that says or implies "FDA approved" when the device has not received the required clearance is treated as false labeling.
No — it covers the contract manufacturer only. If your brand specifies, owns, or labels the device, you are a specification developer and must hold your own FDA establishment registration plus device listings.
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Reviewed by Hector Matos, Senior Regulatory Compliance Specialist · Last reviewed July 2026