Medical Device
Listing Services
Most medical device establishments registered with the FDA must also list their devices under 21 CFR Part 807 — identifying each device category, product code, and classification. FDA Registration Assistance manages the complete Medical Device Listing process for foreign and domestic companies — ensuring your devices are accurately listed, properly classified, and fully compliant with FDA requirements.
What Is Medical Device Listing & Who Is Required to List
Medical Device Listing is the process by which registered medical device establishments inform the FDA about the types of devices they manufacture, prepare, propagate, compound, assemble, or distribute under 21 CFR Part 807. Most establishments that are required to register with the FDA must also list their devices — including devices produced solely for export. Listing allows the FDA to identify the generic categories of devices in commercial distribution and is a mandatory compliance requirement for both domestic and foreign device companies. FDA Registration Assistance handles the complete device listing process on your behalf.
FDA Registration Assistance manages every aspect of your medical device listing — from identifying the correct product codes and device classifications to submitting your listings accurately in the FDA database. Our specialists ensure your device listings are complete, properly coded, and fully compliant with current FDA requirements.
- Required for most foreign & domestic device establishments
- Includes devices manufactured exclusively for export
- Listing does not constitute FDA approval or clearance
- Each device must be assigned an FDA product code & classification
- FDA Registration Assistance manages the full listing process
Our Medical Device Listing Services
Everything medical device manufacturers need to accurately list their devices with the FDA — from product code identification and device classification to listing submission and ongoing updates, handled end-to-end by experienced FDA regulatory specialists.
Device Listing Submission
FDA Registration Assistance prepares and submits your FDA Medical Device Listing — ensuring each device is accurately identified with the correct generic device name, product code, FDA classification, and establishment association in the FDA device database.
Product Code & Classification
FDA Registration Assistance identifies the correct FDA product code and device classification for each device — ensuring your listings are associated with the accurate regulatory category and that any applicable exemption limitations or premarket authorization requirements are properly addressed.
Listing Updates & Amendments
FDA Registration Assistance manages ongoing medical device listing updates — including amendments to reflect new device models, changes in device activities, discontinued products, and new product lines — keeping your FDA device listings current and compliant at all times.
Compliance Review & Support
FDA Registration Assistance reviews your device listings for compliance with current FDA requirements — verifying proper product code assignment, classification accuracy, and exemption status — and provides ongoing support to ensure your listings remain accurate and up to date.
Trusted FDA Medical Device Listing Specialists
Helping foreign and domestic medical device manufacturers accurately list their devices with the FDA — ensuring proper product code identification, classification, and full 21 CFR Part 807 compliance.
How Our Medical Device Listing Service Works
A simple four-step process to get your medical devices accurately listed and compliant with FDA requirements.
Submit Your Device Information
Provide your device names, intended uses, device descriptions, and establishment registration number. FDA Registration Assistance reviews your device information and determines the correct product codes and FDA classifications.
Listing Prepared & Reviewed
FDA Registration Assistance prepares your complete FDA Medical Device Listing — assigning accurate product codes, device classifications, and regulatory identifiers — and conducts a thorough compliance review before submission.
Listing Submitted to FDA
FDA Registration Assistance submits your completed Medical Device Listing to the FDA — confirming your devices are actively listed in the FDA device database with accurate product codes, classifications, and establishment associations.
Listed & Maintained
FDA Registration Assistance confirms your device listings are active and accurate, then manages ongoing listing updates and amendments — keeping your FDA device listings current, compliant, and ready for FDA review at any time.
What an FDA-Compliant Medical Device Listing Service Must Do
Under 21 CFR Part 807, a registered establishment — or the service acting on its behalf — carries the following legally-grounded responsibilities for every listed device.
Identify the Correct Product Code
Assign the proper three-letter FDA product code based on intended use and technological characteristics, ensuring the device is filed under the correct generic category in 21 CFR Parts 862–892.
Verify Device Classification
Determine and document the correct device class (Class I, II, or III) and confirm any general-control or special-control exemptions, including limitations under 21 CFR §xxx.9 for the applicable part.
Link Premarket Authorization
Reference the applicable 510(k), De Novo, PMA, or HDE submission number in the listing, or document the regulatory basis for any exemption claimed under 21 CFR Part 807.65 or part-specific exemption rules.
Submit Through FURLS/DRLM
File the listing electronically through the FDA Unified Registration and Listing System / Device Registration and Listing Module — the only FDA-accepted submission channel since FDAAA 2007.
Maintain 30-Day Update Compliance
Submit changes to devices, activities, ownership, or U.S. Agent within 30 days of the change, as required by 21 CFR Part 807.26 — including new device models, discontinuations, and activity changes.
Complete Annual Certification
Review and certify the accuracy of all device listings every fiscal year between October 1 and December 31 — without certification, the establishment and all linked listings are deactivated on January 1.
Preserve Records for FDA Inspection
Maintain supporting documentation — device descriptions, intended-use statements, labeling, and classification rationale — sufficient to substantiate every entry during FDA inspections under 21 CFR Part 820.
Coordinate Foreign-Establishment Requirements
For non-U.S. manufacturers, ensure a DUNS Number is assigned and a U.S. Agent is properly designated under 21 CFR Part 807.40 before listings are activated and remain valid.
Medical Device Listing vs. Medical Device Establishment Registration
These two FDA requirements are frequently confused — but they are separate, complementary obligations under 21 CFR Part 807.
| Medical Device Listing | Establishment Registration | |
|---|---|---|
| Who Designates It | The registered establishment, identifying each device it makes or processes | The owner/operator of the physical facility (manufacturer, repackager, etc.) |
| What It Represents | A specific medical device (proprietary name, product code, classification) | The physical site where devices are manufactured, processed, or handled |
| Required By | 21 CFR Part 807, Subpart B (Sections 807.20–807.39) | 21 CFR Part 807, Subpart B (Sections 807.20–807.22) and Subpart E for foreign sites |
| Governing Statute | FD&C Act §510(j) [21 U.S.C. §360(j)] | FD&C Act §510(b) and §510(i) [21 U.S.C. §360(b),(i)] |
| Primary Function | Tells FDA which devices are in U.S. commercial distribution | Tells FDA where devices are made and identifies the responsible owner/operator |
| Required For | Every device — multiple listings per establishment are typical | Each physical establishment — one registration per site, renewed annually |
Self-Filing vs. FDA Registration Assistance
Filing a Medical Device Listing yourself is technically possible — but the regulatory complexity, classification risk, and ongoing maintenance burden make professional service the standard for most device companies.
| Self-Filing (DIY) | Recommended FDA Registration Assistance | |
|---|---|---|
| Cost | $0 service cost (only the $11,423 FY 2026 FDA establishment fee) — plus internal staff time, often 15–40 hours per device | $249 USD per device, all-inclusive — product code research, classification, FURLS/DRLM submission, and confirmation |
| Availability | Limited to internal regulatory staff during business hours — bottlenecks during the October–December annual certification rush | Dedicated regulatory specialists with priority handling during the annual certification window — same-business-day responses |
| Domain-Specific Support | Requires in-house expertise on 21 CFR Parts 862–892, product code databases, exemption rules, and 510(k) linkages | 15+ years of FDA medical device experience across all device classes, product codes, and foreign-establishment scenarios |
| Risk of Failure | High — wrong product code, missed classification, omitted 510(k) reference, or missed 30-day updates trigger misbranding and import refusal | Very low — every listing is reviewed against current FDA databases before submission; 100% accuracy rate across 1,000+ listings |
| Confirmation & Handling | You manage FURLS account, PIN/PCN credentials, and submission confirmations yourself — no audit trail if disputes arise | Complete submission record, FDA confirmation captured and archived, optional Medical Device Listing Certificate for distributors |
| Renewal/Update Tracking | Manual — internal calendar reminders for the October–December annual certification and 30-day update rule | Active monitoring — automatic reminders, annual certification handled on your behalf, all 30-day updates filed on time |
Using a Friend or Unrelated Party vs. FDA Registration Assistance
FDA allows any authorized user to submit a listing — but the legal accountability stays with the establishment. Here's how an informal helper compares to a dedicated regulatory service.
| Friend or Unrelated Party | Recommended FDA Registration Assistance | |
|---|---|---|
| Government Fee | $0 — FDA charges no separate fee for the Medical Device Listing record itself (only the $11,423 FY 2026 establishment registration user fee paid to FDA) | $0 government fee for listing — same as DIY — plus $249 per device for full professional handling and accountability |
| Pros | No service cost; flexible if the helper already has regulatory training | Regulatory accountability, accurate product-code assignment, professional documentation, ongoing maintenance, audit-ready record-keeping |
| Cons | Helper has no professional accountability; mistakes still fall on the establishment legally; no audit trail; high risk of misclassification, missed updates, and lapsed annual certification | Service fee per device — offset by avoided FDA enforcement, import refusals, marketplace delistings, and the cost of corrective actions |
| Best For | Almost no real-world scenario — even regulatory professionals working informally lack the database access and process discipline of a dedicated service | Any device establishment that distributes in U.S. commerce — domestic or foreign, single device or full product portfolio, Class I through Class III |
Key FDA Medical Device Listing Terms
Industry-specific terms you'll encounter when listing a medical device with the FDA.
Why Medical Device Listings Get Flagged, Rejected, or Pulled
These are the failure modes that most commonly cause FDA Warning Letters, import refusals, marketplace delistings, and lapsed registrations. Each is preventable with proper professional handling.
Wrong or Missing Product Code
Assigning a product code that doesn't match the device's intended use is the #1 cause of FDA rejection. Wrong codes trigger automatic detention at U.S. ports and force resubmission under the correct generic category.
Missed October–December Certification
Failing to complete the annual certification before December 31 automatically deactivates the establishment and every device listing on January 1 — rendering every device misbranded and stopping all U.S. distribution.
Late or Skipped 30-Day Updates
21 CFR §807.26 requires updates within 30 days of any change — new device, discontinued device, ownership change, or activity change. Skipping the 30-day window creates inaccurate records and is routinely cited by FDA inspectors.
Missing 510(k) Reference
If a listed device requires 510(k) clearance, the K-number must appear in the listing record. Omitting it — or referencing an irrelevant predicate — flags the device as marketed without authorization and triggers enforcement action.
Misapplied 510(k) Exemption
Many Class I and some Class II devices are 510(k)-exempt — but every exemption is bound by limitations in 21 CFR §xxx.9 of the applicable part. Exceeding those limitations (e.g., higher-risk intended use) voids the exemption and the device must be re-listed correctly.
Invalid U.S. Agent Designation
Foreign establishments that designate a U.S. Agent who is unreachable, no longer associated with the company, or never formally accepted the role have their entire registration — and every listing — suspended until a valid designation is made.
Specification Developer Not Listed
When a brand owner outsources manufacturing, both the contract manufacturer and the specification developer must list the same device under their own FEI Numbers. Skipping the specification-developer listing is a common, FDA-cited compliance gap.
Inconsistent Device Names & Labeling
The proprietary name on the FDA listing must match the device label exactly. Mismatches between the listing, the 510(k) clearance, and the physical product label cause Amazon and Walmart to reject medical-category listings and trigger FDA misbranding citations.
Complete FDA Medical Device Compliance Solutions
We offer a full range of FDA medical device compliance services — from establishment registration and device listing to U.S. Agent services, QMS support, 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 Listing
Find answers to the most common questions about FDA Medical Device Listing, annual renewal requirements, and how FDA Registration Assistance helps device companies stay compliant.
What is FDA Medical Device Listing?
FDA Medical Device Listing is the process by which registered medical device establishments provide the FDA with information about the types of devices they manufacture, prepare, propagate, compound, assemble, or distribute. It is required under 21 CFR Part 807 for most establishments registered with the FDA.
Who is required to list medical devices with the FDA?
Most domestic and foreign medical device establishments that are required to register with the FDA must also list their devices. This includes manufacturers, contract manufacturers, specification developers, distributors who distribute under their own name, and repackagers or relabelers.
Are devices manufactured exclusively for export required to be listed?
Yes. Medical devices produced solely for export must still be listed with the FDA under 21 CFR Part 807. Export-only devices are not exempt from the listing requirement, even if they are never marketed or distributed within the United States.
Does listing a medical device mean it is FDA approved?
No. Medical Device Listing does not constitute FDA approval, clearance, or authorization of the device or the establishment. Unless a device is specifically exempt, premarket authorization — such as a 510(k) clearance, PMA approval, or De Novo classification — is required before commercial distribution in the United States.
What is an FDA product code?
An FDA product code is a three-letter identifier assigned to a specific type of medical device based on its intended use and technological characteristics. Each product code is associated with a generic device category defined in 21 CFR Parts 862–892. The correct product code must be assigned when listing a device with the FDA.
How do I determine the correct product code for my device?
The correct product code is determined by the device's intended use, design, and technological characteristics. FDA Registration Assistance reviews your device description and intended use to identify the appropriate FDA product code and device classification — ensuring your listing is accurately associated with the correct regulatory category.
What is device classification under FDA regulations?
FDA classifies medical devices into three classes — Class I, Class II, and Class III — based on the level of risk they pose and the regulatory controls needed to ensure safety and effectiveness. Class I devices are subject to general controls, Class II devices require special controls (often including 510(k) clearance), and Class III devices generally require Premarket Approval (PMA).
Do exempt devices still need to be listed?
Yes. Even devices exempt from the 510(k) Premarket Notification requirement must still be listed with the FDA. Exemption from the 510(k) requirement does not exempt a device from the listing requirement. All exemptions are also subject to limitations outlined in 21 CFR Part xxx.9 for the applicable device classification.
Is there a fee for FDA Medical Device Listing?
There is no separate FDA fee for medical device listing. However, most establishments are subject to an annual FDA Medical Device Establishment Registration user fee — $11,423 for FY 2026. Device listing is included as part of the establishment registration process. FDA Registration Assistance's service fee covers preparation and submission of your device listings.
When must medical device listings be submitted or updated?
Initial device listings must be submitted at the time of establishment registration. Updates are required within 30 days of any change — including new devices placed into commercial distribution, devices no longer distributed, changes in device activities, or changes in ownership. FDA Registration Assistance manages all required updates on your behalf.
Can foreign establishments list devices with the FDA?
Yes. Foreign medical device establishments that are required to register with the FDA must also list their devices. Foreign establishments are subject to the same device listing requirements as domestic establishments under 21 CFR Part 807. FDA Registration Assistance assists foreign device companies worldwide with both registration and listing.
What is the difference between device listing and premarket notification (510(k))?
Device listing is an administrative requirement to inform the FDA of the devices an establishment manufactures or distributes — it is not a review or clearance process. A 510(k) Premarket Notification is a submission to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device. Listing is required for all applicable establishments; 510(k) clearance is required before marketing most Class II devices.
How is a medical device listing submitted to the FDA?
Medical device listings are submitted electronically through the FDA's Unified Registration and Listing System (FURLS) / Device Registration and Listing Module (DRLM). FDA Registration Assistance manages the full electronic submission process on behalf of domestic and foreign device manufacturers.
What information is required for a medical device listing?
A medical device listing requires the establishment registration number, the proprietary and common device names, the FDA product code, device classification, intended use, whether the device is exempt from 510(k) requirements, and the type of device activity (e.g., manufacture, repackage, distribute). FDA Registration Assistance collects and prepares all required listing information on your behalf.
Can FDA Registration Assistance list multiple devices for a single establishment?
Yes. FDA Registration Assistance can prepare and submit listings for multiple devices — including entire product lines — for a single establishment. We identify the correct product code and classification for each device and manage all listings through the FDA's electronic submission system.
Does FDA Registration Assistance assist with the full medical device compliance process?
Yes. FDA Registration Assistance provides comprehensive medical device compliance support — including establishment registration, device listing, U.S. Agent services, labeling review, DUNS number assistance, listing certificate issuance, QMS/cGMP support, annual registration renewal, and import alert resolution. Contact us to discuss your full compliance requirements.
How much does FDA Medical Device Listing cost, and what is included?
FDA Registration Assistance charges $249 USD per device for Medical Device Listing. This covers product code identification, device classification verification, preparation of the listing record, electronic submission through FURLS/DRLM, and confirmation of an active FDA listing. Class I products incur no separate FDA listing fee. If your establishment also needs the FY 2026 Establishment Registration (the $11,423 FDA user fee paid directly to FDA), the typical first-year bundle is: $11,423 (FDA establishment fee, paid to FDA) + our Establishment Registration service + $249 per device listing. For one establishment with three devices, that's $11,423 to FDA plus our service charges plus $747 in listings ($249 × 3). Annual renewal years repeat the $11,423 FDA fee plus our renewal and any listing updates.
Can a friend, relative, or unrelated party submit my Medical Device Listing for me?
Technically yes — but it is strongly discouraged. FDA allows any authorized official with a valid FURLS account to file a listing, but the legal responsibility for every entry remains with the registered establishment. If a non-specialist misassigns a product code, omits a 510(k) reference, misclassifies the device, or misses the 30-day update or annual certification deadlines, the establishment — not the helper — receives the FDA Warning Letter, import refusal, and marketplace delisting. A dedicated professional service like FDA Registration Assistance maintains the regulatory expertise, FURLS access discipline, and accountability that informal helpers cannot.
What happens if my Medical Device Listing is missing, late, or inaccurate?
The device is deemed misbranded under FD&C Act §502(o) and adulterated under §501(h). Real-world consequences include FDA Warning Letters, automatic detention without physical examination at U.S. ports under import alerts, refusal of admission for imported shipments, injunctions and seizure actions, civil money penalties, listing takedowns on Amazon and Walmart Marketplace, loss of Shopify medical-category approval, and termination of hospital and distributor contracts that require verified FDA registration. The establishment can also be deactivated entirely if the annual October–December certification is missed.
How do I change or update a medical device on my existing FDA registration?
Updates are filed through FURLS/DRLM within 30 days of the change, as required by 21 CFR §807.26. Common updates include: adding a new device model, discontinuing a device no longer in commercial distribution, correcting a product code or classification, changing the proprietary or common name, adding or removing device activities (e.g., adding repackaging), updating the U.S. Agent, and reflecting ownership changes. FDA Registration Assistance manages every update on your behalf, including coordinating with the annual October–December certification so all changes are properly reflected before the next fiscal year.
Do I need an FDA Medical Device Listing if I only sell my product on Amazon as a wellness item?
Only if your product meets the FDA definition of a medical device. Under Section 201(h) of the FD&C Act, a product is a medical device if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Many general-wellness products — basic fitness trackers, posture trainers, sleep monitors without disease claims — fall under FDA's General Wellness Policy and don't require listing. However, the moment your Amazon listing makes a disease, diagnostic, or therapeutic claim (even in bullet points or A+ content), the product becomes a regulated medical device and must be both registered and listed. Amazon increasingly verifies FDA registration before approving medical-category listings.
Can the same medical device be listed under more than one FDA product code?
Yes — and in many cases it must be. If a single device has multiple distinct intended uses that fall under different generic device categories — for example, a multi-parameter patient monitor that includes ECG, SpO2, and NIBP — each functional capability is listed under its own three-letter product code. The same device record is then associated with every applicable product code in the FDA database. FDA Registration Assistance identifies all applicable product codes during intake so you don't under-list a multi-function device, which is a common cause of FDA inspection findings.
Does my contract manufacturer's FDA registration cover my Medical Device Listing requirement?
No. Both establishments must register and list the device separately. The contract manufacturer registers and lists the device under its own FEI Number for the manufacturing activity, and the specification developer (the brand owner who designs the device) registers and lists the same device under its own FEI Number as a specification developer. Both filings reference the same physical device but represent two distinct regulatory roles. Skipping either side is a frequent FDA inspection citation and can leave your device legally unable to enter U.S. commerce.
Is my FDA Medical Device Listing publicly searchable?
Yes. Active medical device listings are publicly accessible through the FDA Establishment Registration & Device Listing database at accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm. Anyone — customers, distributors, hospital procurement teams, Amazon compliance, Walmart Marketplace reviewers, U.S. Customs — can search by establishment name, FEI Number, proprietary device name, or product code and see your registration status, the listed devices, the assigned product codes, and the device class. That transparency is exactly why accurate listings are critical for commercial credibility.
What is the difference between an FDA Registration Number and a Medical Device Listing Number?
They identify different things. The Registration Number (tied to your FEI Number) identifies the physical establishment — the manufacturing, repackaging, or specification-development site. The Listing Number identifies a specific device that the establishment manufactures or distributes. One establishment (one Registration Number) typically has many Listing Numbers — one per device. Both must be active for the device to be legally marketed in the U.S. Confusing the two during distributor verification, customs filings, or platform onboarding routinely causes delays.
If my facility moves to a new address, do I need to update my Medical Device Listings?
It depends on the type of change. A name or suite-number change at the same physical location is updated in FURLS within 30 days and automatically flows to all linked device listings. However, a move to a different physical facility generally requires a new establishment registration for the new site — meaning a new FEI Number — and every device listing must be re-associated with the new establishment. FDA Registration Assistance handles both scenarios, ensures the new establishment is registered before the move, and keeps listings continuously active to avoid a compliance gap.
Can I sell my medical device on Amazon, Walmart, or Shopify without an FDA Medical Device Listing?
No — not if the product meets the FDA definition of a medical device. Amazon's Restricted Products policy, Walmart Marketplace, and Shopify's compliance partners all require sellers in medical and health categories to provide a valid FDA establishment registration number and active device listing before approving listings. Selling without one results in listing takedowns, account suspension, withheld payouts, and potential FDA enforcement separate from platform action. Increasingly, these platforms cross-reference the FDA Establishment Registration & Device Listing database in real time.
How can a buyer or distributor verify that my medical device is properly FDA-listed?
Buyers verify FDA listings through the public FDA Establishment Registration & Device Listing database at accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm. They search by establishment name, FEI Number, proprietary device name, or product code, and the database returns active/inactive status, the listed devices, and the responsible establishment. For added commercial credibility, FDA Registration Assistance issues an official Medical Device Listing Certificate on request — a document many distributors, hospital procurement teams, and international partners require alongside the public FDA record.
What happens to my Medical Device Listing if I miss the annual October–December certification?
Your establishment registration and every associated device listing are automatically marked expired in the FDA database on January 1. Every previously listed device becomes misbranded the moment the new fiscal year begins. Imports are subject to detention and refusal, Amazon and Walmart can pull the listings, and reinstating the registration requires paying the new fiscal year's user fee (currently $11,423 for FY 2026) and completing the annual certification before commercial distribution can lawfully resume. FDA Registration Assistance manages the October–December certification on your behalf to prevent the lapse entirely.
I sell only software — does my Software as a Medical Device (SaMD) need to be listed?
Yes, if the software meets the FDA definition of a medical device. Standalone software that performs regulated medical-device functions — diagnostic imaging analysis, clinical decision support outside the §3060 exclusions of the 21st Century Cures Act, patient-monitoring algorithms, mobile medical apps under FDA's Policy for Device Software Functions — must be listed under the appropriate three-letter product code (commonly QIH, QLB, MEY, or others depending on function). The software developer is the specification developer and must register its establishment and list the SaMD product, even with no physical hardware. FDA Registration Assistance handles SaMD listings for U.S. and foreign software companies.
List Your Medical Devices with the FDA 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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