Medical Device
Listing Services
Professional FDA Medical Device Listing assistance for covered domestic and foreign device establishments — including product-code review, classification support, FURLS/DRLM submission, and ongoing listing maintenance.
Medical Device Listing is the electronic FDA filing used by covered device establishments to identify the devices they manufacture or process and the activities performed on those devices. Most establishments required to register under 21 CFR Part 807 must also list applicable devices through FDA's FURLS / Device Registration and Listing Module (DRLM). If a device requires 510(k), De Novo, PMA, or another applicable premarket authorization, that authorization must generally be obtained before the device is listed for U.S. marketing. Registration and listing do not mean FDA approval, clearance, certification, or endorsement.
What Is FDA Medical Device Listing & Who Needs It?
FDA Medical Device Listing identifies devices associated with a registered device establishment and the activities performed on those devices. Most establishments required to register are also required to list applicable devices, but the obligation depends on the establishment type and activity. FDA Registration Assistance reviews the regulatory role first, then prepares the appropriate listing record.
We support product-code research, classification review, premarket-submission linkage when applicable, proprietary-name entry, electronic filing in FURLS/DRLM, and later listing updates. We also distinguish device listing from establishment registration and from FDA premarket authorization so each requirement is handled correctly.
- Required for most — but not every — FDA-registered device establishment
- Filed electronically through FURLS / DRLM
- Premarket authorization must be obtained first when required
- Listing information is reviewed annually between October 1 and December 31
- Listing does not constitute FDA approval, clearance, or certification
Medical Device Listing Support from Classification Through Filing
A complete listing workflow focused on accurate product identification, correct regulatory linkage, clean electronic submission, and practical maintenance after filing.
Device Listing Preparation & Submission
We prepare the FDA listing record and submit it electronically through FURLS/DRLM, linking the device to the appropriate registered establishment and activity.
Product Code & Classification Review
We research the applicable three-letter FDA product code and review device classification, intended use, and regulatory pathway before filing.
Premarket Authorization Linkage
When a device requires 510(k), De Novo, PMA, HDE, or another applicable authorization, we verify the relevant FDA submission number is available and correctly linked before listing.
Listing Updates & Annual Review Support
We support listing changes throughout the year and the annual October 1–December 31 review so records remain current as products, names, activities, or distribution status change.
Medical Device Listing Support Built for Global Companies
Structured FDA listing assistance for companies that need accurate records, clear regulatory distinctions, and reliable annual maintenance.
How Our FDA Medical Device Listing Service Works
A four-step process from device review through FDA submission and listing maintenance.
Submit Device & Establishment Information
Provide the device name, intended use, description, establishment information, current labels, and any applicable premarket submission number.
Product Code & Regulatory Pathway Reviewed
We evaluate the likely FDA product code, device class, establishment activity, exemption status, and premarket-authorization linkage before preparing the listing.
Listing Submitted Through FURLS / DRLM
We prepare and electronically submit the device listing through FDA's registration and listing system using the applicable establishment record.
Confirmation & Ongoing Maintenance
We document the submission outcome and support later changes plus the annual October–December listing review so the record remains current.
What an Accurate FDA Device Listing Workflow Must Address
A compliant listing record depends on accurate device identification, establishment activity, regulatory status, electronic submission, and ongoing maintenance.
Confirm the Establishment Must List
Determine the establishment type and activity first because listing duties differ among manufacturers, contract manufacturers, specification developers, repackagers, relabelers, importers, and other entities.
Identify the Correct Product Code
Use intended use, design, the applicable classification regulation, and FDA databases to identify the relevant three-letter product code.
Verify Premarket Status
Determine whether the device is exempt or requires 510(k), De Novo, PMA, HDE, or another authorization; when authorization is required, obtain it before listing for U.S. marketing.
Report Proprietary Names & Activities
Enter current proprietary names and identify the activities the establishment performs on or to the device as required by FDA's listing process.
Submit Electronically Through DRLM
Create or update the listing in FURLS/DRLM using the correct establishment and owner/operator account information.
Review Listing Information Annually
Review and update listing information each year between October 1 and December 31 at the same time annual establishment registration is reviewed.
Update Listings When Changes Occur
Use FURLS/DRLM during the year to add, change, deactivate, or reactivate listings as products and activities change.
Coordinate Foreign Establishment Requirements
For covered foreign establishments, ensure registration and the required U.S. Agent designation are in place before devices are imported or offered for import into the United States.
Medical Device Listing vs. Establishment Registration
Both are part of FDA's Part 807 framework, but they identify different things and applicability depends on establishment activity.
| Medical Device Listing | OptionEstablishment Registration | |
|---|---|---|
| What It Identifies | The device(s), proprietary names, product code, regulatory linkage, and activities performed | The establishment, owner/operator, location, establishment type, and related registration information |
| Who Files | Covered establishments required to list based on their device activity | Owners/operators of establishments required to register under 21 CFR Part 807 |
| FDA Fee | No separate FDA fee for the listing record itself | Annual FDA establishment registration user fee applies to most fee-paying establishments |
| Timing | Initial listing within the applicable 30-day period; annual review Oct 1–Dec 31; updates during the year as changes occur | Initial registration within the applicable period; annual registration Oct 1–Dec 31 |
| Premarket Authorization | If required, the device generally cannot be listed for U.S. marketing until the applicable submission is cleared, approved, or granted | Registration does not replace or provide premarket authorization |
| FDA Approval? | No — listing does not denote approval, clearance, certification, or authorization | No — registration does not denote approval, clearance, certification, or authorization |
Self-Filing vs. FDA Registration Assistance
Authorized company personnel can use FURLS/DRLM directly. A professional service adds regulatory research, filing support, and maintenance discipline.
| Self-Filing | OptionFDA Registration Assistance | |
|---|---|---|
| Professional Service Fee | $0; company handles research and filing internally | $249 per device |
| Product-Code Review | Company researches FDA classification databases and evaluates the correct code | Product-code and classification review included |
| Premarket Linkage | Company confirms whether an FDA authorization number is required before listing | Applicable authorization or exemption status reviewed before submission |
| FURLS / DRLM Filing | Company prepares and submits the listing itself | Listing record prepared and electronically submitted on the company's behalf |
| Ongoing Changes | Company monitors product, activity, name, and distribution changes | Support available for later listing updates and annual review |
| Documentation | Company maintains its own submission records | Submission records and confirmation information organized for the client |
Informal Help vs. Professional Regulatory Support
A company can authorize others to assist with filing, but responsibility for accurate FDA information remains with the regulated firm.
| Informal / Internal Helper | OptionFDA Registration Assistance | |
|---|---|---|
| FDA Listing Fee | No separate FDA fee for the listing record | No separate FDA listing fee; $249 professional service fee per device |
| Regulatory Research | Depends on the helper's familiarity with Part 807 and device classification | Product-code, classification, and filing review included |
| Submission Process | Helper needs appropriate authorized access and DRLM knowledge | Structured electronic submission support through FURLS/DRLM |
| Accountability | The regulated establishment remains responsible for information submitted | The establishment remains legally responsible; our service provides documented professional handling |
| Maintenance | Depends on internal reminders and availability | Ongoing update and annual-review support available |
| Best Fit | Companies with trained in-house regulatory personnel | Companies that want external regulatory filing support and a consistent process |
Key FDA Medical Device Listing Terms
Plain-English definitions of the terms most often encountered during FDA device registration and listing.
Issues That Can Delay or Complicate a Medical Device Listing
Common problems include mismatched device information, incorrect regulatory assumptions, incomplete establishment data, and records that are not updated when circumstances change.
Wrong Product Code
A product code that does not match intended use or FDA classification can create inconsistent records and may require correction.
Premarket Authorization Not Yet Obtained
If the device requires clearance, approval, or another authorization, it generally cannot be listed for U.S. marketing until that authorization is obtained.
Incorrect Establishment Activity
Using the wrong activity — manufacturer, contract manufacturer, repackager, relabeler, specification developer, or another role — can make the FDA record inaccurate.
Missing or Outdated Proprietary Names
Current proprietary or brand names should be maintained in the listing record. Incomplete names can make verification more difficult.
Inactive Establishment Registration
A listing tied to a registration that has not been properly renewed can create inactive or failed registration/listing status and disrupt the compliance record.
Foreign U.S. Agent Problems
Covered foreign establishments must maintain the required U.S. Agent designation as part of registration. Unresolved agent confirmation or contact issues can interfere with registration.
Listing Changes Not Reflected
New devices, discontinued devices, changed activities, or revised manufacturing associations should be reflected in DRLM as changes occur.
Treating Listing as FDA Approval
Registration and listing do not denote FDA approval, clearance, certification, or endorsement. Marketing claims suggesting otherwise can create separate compliance concerns.
Complete FDA Medical Device Compliance Services
Keep the full medical-device compliance workflow connected with related registration, U.S. Agent, labeling, quality-system, renewal, and import support.
Medical Device Establishment Registration
Annual FDA establishment registration support for covered domestic and foreign medical device establishments.
Medical Device Listing
Product-code, classification, and FURLS/DRLM listing support for covered device establishments.
Medical Device Labeling & Product Review
Review device labeling and product documentation against applicable FDA labeling and regulatory requirements.
Medical Device DUNS Request Assistance
DUNS assistance for companies that need accurate business-identifier information for FDA device-registration workflows.
Medical Device U.S. Agent Services
Annual U.S. Agent representation for covered foreign medical device establishments.
Medical Device Listing Verification Certificate
Professional verification document prepared from applicable FDA registration/listing records. Not issued or certified by FDA.
QMSR / Quality System Support
Support for FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, and applicable quality-system requirements.
Medical Device Annual Establishment Renewal
Annual FDA establishment registration renewal support during the October 1–December 31 renewal period.
Import Alert & Device Detention Resolution
Case-specific support for FDA medical-device detentions, import compliance issues, and Import Alert 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 — FDA Medical Device Listing
Answers to common questions about who must list, how FDA listings work, fees, product codes, updates, and verification.
What is FDA Medical Device Listing?
FDA Medical Device Listing is the electronic process by which covered registered establishments identify the devices they make or process and the activities performed on those devices. Most establishments required to register under 21 CFR Part 807 are also required to list applicable devices.
Who is required to list medical devices with the FDA?
Most establishments that must register with FDA must also list their devices, but the requirement depends on the establishment's activity. Manufacturers, contract manufacturers, specification developers, repackagers, relabelers, and several other establishment types may have listing obligations; some entities, such as a wholesale distributor that does not manufacture, repackage, process, or relabel a device, are exempt.
Are devices manufactured exclusively for export required to be listed?
U.S. manufacturers that manufacture devices for export only are a recognized establishment type and are required to register and list. For foreign establishments, U.S. registration/listing requirements are tied to devices imported or offered for import into the United States, so export-only situations should be evaluated based on the establishment's activity and destination market.
Does listing a medical device mean it is FDA approved?
No. FDA states that registration and listing do not denote approval, clearance, authorization, certification, or endorsement of an establishment or its devices. If a device requires premarket authorization, that is a separate requirement.
What is an FDA product code?
An FDA medical device product code is generally a three-letter identifier for a generic device category. It connects the device to FDA's classification framework and helps identify the applicable regulation, class, and premarket requirements.
How do I determine the correct product code for my device?
The product code is identified by comparing intended use, indications, design, technological characteristics, and applicable FDA classification regulation and databases. If a device has a cleared or approved premarket submission, the product code assigned to that authorization should be used.
What is device classification under FDA regulations?
FDA classifies devices into Class I, II, or III based on the regulatory controls needed to provide reasonable assurance of safety and effectiveness. Class, product code, exemptions, and premarket pathway are related but distinct parts of the analysis.
Do exempt devices still need to be listed?
Often, yes. Being exempt from 510(k) does not automatically exempt an establishment from device listing. Whether listing is required depends on the establishment's activity and the specific device requirements.
Is there a fee for FDA Medical Device Listing?
FDA does not charge a separate government fee for creating a medical device listing record. Most fee-paying establishments must separately pay the annual establishment registration user fee. For FY 2026, FDA lists that fee as $11,423. Our Medical Device Listing professional service is $249 per device.
When must medical device listings be submitted or updated?
FDA says initial registration and/or listing information generally must be submitted within 30 days of beginning an activity or putting a device into commercial distribution. Listing information is reviewed each year between October 1 and December 31, and can be updated during the year as changes occur.
Can foreign establishments list devices with the FDA?
Yes. Covered foreign device establishments that manufacture, prepare, propagate, compound, or process devices imported into the United States must register and identify a U.S. Agent, and most such establishments must also list applicable devices and activities.
What is the difference between device listing and premarket notification (510(k))?
Device listing is an administrative FDA record associated with a registered establishment. A 510(k) is a premarket submission for devices that require clearance based on substantial equivalence. If a device requires 510(k) clearance, FDA says it can only be listed after the 510(k) is cleared.
How is a medical device listing submitted to the FDA?
Medical device listings are submitted electronically through FDA's Unified Registration and Listing System (FURLS), specifically the Device Registration and Listing Module (DRLM), unless FDA grants an electronic-submission waiver.
What information is required for a medical device listing?
The listing process may require the product code, proprietary names, activities performed, and an applicable FDA premarket submission number when authorization is required. Exact fields depend on the device and establishment activity.
Can FDA Registration Assistance list multiple devices for a single establishment?
Yes. We can prepare and submit multiple device listings for one establishment or owner/operator, subject to the regulatory status and information available for each device. The $249 professional service fee applies per device.
Does FDA Registration Assistance assist with the full medical device compliance process?
Yes. Related services include establishment registration, U.S. Agent representation, DUNS assistance, labeling and product review, QMSR support, annual renewal, listing verification documentation, and import/detention support.
How much does FDA Medical Device Listing cost, and what is included?
Our Medical Device Listing service is $249 per device. It includes product-code and classification review, listing-record preparation, applicable premarket-status review, FURLS/DRLM submission support, and confirmation documentation. FDA does not charge a separate fee for the listing record itself; an establishment registration fee may apply separately.
Can a friend, relative, or unrelated party submit my Medical Device Listing for me?
A company may authorize appropriate personnel or representatives to assist with registration and listing functions, but the regulated establishment remains responsible for the accuracy of its FDA information. Device-regulatory experience can reduce avoidable classification and filing mistakes.
What happens if my Medical Device Listing is missing, late, or inaccurate?
A missing or inaccurate required listing can create a failed-to-list status and may make a device misbranded under applicable law. Depending on the facts, inaccurate registration/listing information can contribute to import delays, refusal, or other FDA compliance action. The consequence is case-specific rather than automatic.
How do I change or update a medical device on my existing FDA registration?
Owners/operators can use FURLS/DRLM throughout the year to change, deactivate, or reactivate listings and update proprietary names and other listing information as changes occur. The annual October–December review is also used to confirm and update listing information.
Do I need an FDA Medical Device Listing if I only sell my product on Amazon as a wellness item?
Only products that meet the legal definition of a medical device are subject to device requirements. Many low-risk general-wellness products may fall outside device regulation depending on intended use and claims. Marketplace wording does not override FDA law; disease, diagnostic, treatment, or body-function claims can materially affect regulatory status.
Can the same medical device be listed under more than one FDA product code?
A device may involve more than one product code when multiple regulated device functions or categories legitimately apply, but that determination should be based on FDA's classification framework and any applicable premarket authorization. It should not be assumed that every multi-function product needs multiple codes.
Does my contract manufacturer's FDA registration cover my Medical Device Listing requirement?
Not necessarily. Registration and listing duties are tied to the activity performed by each establishment. A contract manufacturer and a specification developer can each have their own registration/listing responsibilities for the same device, so one party's record does not automatically satisfy another party's obligations.
Is my FDA Medical Device Listing publicly searchable?
Yes. FDA makes releasable establishment registration and device listing information publicly searchable. FDA states that the public Registration & Listing database is updated weekly, usually every Monday.
What is the difference between an FDA Registration Number and a Medical Device Listing Number?
An establishment registration number identifies a registered establishment, while a device listing number identifies a listing record associated with a medical device. One registered establishment can be associated with multiple device listings.
If my facility moves to a new address, do I need to update my Medical Device Listings?
A facility move can require updates to establishment registration information and may affect linked device listings, depending on whether the change is an address correction or a move to a different physical establishment. The change should be reviewed in FURLS/DRLM so associations remain accurate.
Can I sell my medical device on Amazon, Walmart, or Shopify without an FDA Medical Device Listing?
If the product is a regulated medical device and the responsible establishment has registration/listing duties, marketplace sales do not eliminate those FDA requirements. Amazon, Walmart, Shopify, or another platform is a sales channel; FDA requirements depend on the product and regulated activities, not the platform alone.
How can a buyer or distributor verify that my medical device is properly FDA-listed?
A buyer or distributor can search FDA's public Establishment Registration & Device Listing database by company, device, product code, registration/FEI number, and other fields. FDA says the database is updated weekly, usually every Monday. A private verification certificate can summarize public records, but it is not issued or certified by FDA.
What happens to my Medical Device Listing if I miss the annual October–December certification?
FDA requires registration information to be submitted and listing information to be reviewed each year between October 1 and December 31. If annual establishment registration is not completed, the establishment can lose active registration status and linked listings may no longer appear current. FDA does not describe a separate FDA-issued listing-certificate renewal.
I sell only software — does my Software as a Medical Device (SaMD) need to be listed?
Software that meets the statutory definition of a medical device may be subject to registration, listing, and applicable premarket requirements. Whether a software function is regulated depends on intended use and whether it falls within statutory exclusions, FDA enforcement policies, or regulated device-software categories.
List Your Medical Device with the FDA
Send us your device and establishment details. We will review the regulatory pathway, confirm what listing information is needed, and prepare the FDA submission.
Thank You for Reaching Out!
We've received your message and will get back to you within 24 hours. If you need immediate assistance, please call us directly.