FDAbasics offers complete FDA Compliance and Registration Services for the Medical Device Industry
Any establishment involved in manufacturing, distributing, or importing medical devices for the US market must register with the FDA annually and list every device distributed in the United States. Foreign establishments must also designate a US FDA Agent. FDABasics handles the entire process for foreign and domestic manufacturers, importers, and distributors, with registration completed in 4 business days.
We have served clients in 100+ countries since 1995 and hold 5-star ratings on Trustpilot and Google. The FDA does not issue a Certificate of Registration. FDABasics provides one at no extra charge with every completed registration, so you have documentation ready for buyers, importers, and customs brokers.
Ready to Register? We Make It Simple.
Fill in the form for your medical device establishment and we will have your FDA registration number within 4 business days.
FDA Medical Device Compliance Requirements: Step-by-Step for Foreign and Domestic Device Establishments
All establishments follow the same core process. Differences between foreign and domestic establishments are noted inline. Note: for medical devices, the MDUFA registration fee must be paid to the FDA before you can complete the registration submission. FDABasics prepares your User Fee Cover Sheet as part of our registration service so you are ready to pay and proceed without delay.
Step 1: Determine Your Device Classification All medical devices are classified as Class I (low risk), Class II (moderate risk), or Class III (high risk). Your classification determines what premarket submissions are required before US distribution. Use the FDA Product Classification Database to confirm your device classification. Class I devices are generally exempt from premarket review. Most Class II devices require 510(k) clearance. Class III devices require Premarket Approval (PMA).
| Class | Risk Level | Regulatory Controls | Premarket Requirement | Examples |
|---|---|---|---|---|
| Class I | Low risk | General Controls | Generally exempt from premarket review. Establishment registration and device listing still required. | Bandages, tongue depressors, elastic bandages, examination gloves |
| Class II | Moderate risk | General Controls and Special Controls | 510(k) Premarket Notification clearance required for most devices before US distribution. | Infusion pumps, powered wheelchairs, surgical needles, IVD test kits |
| Class III | Highest risk | General Controls and Premarket Approval | Premarket Approval (PMA) required. Most stringent review process. Clinical data generally required. | Pacemakers, heart valves, implantable defibrillators, deep brain stimulators |
Step 2: Obtain a DUNS Number A valid DUNS number (Dun and Bradstreet Data Universal Numbering System number) is required for foreign establishments to create a User Fee account and pay the MDUFA registration fee. FDABasics assists with DUNS number requests and updates for foreign companies. Foreign establishments only. Domestic establishments use an Employer Identification Number (EIN) instead of a DUNS number.
Step 3: Designate a US FDA Agent Your US Agent is your official contact with the FDA, receives inspection notifications and regulatory correspondence on your behalf, and must be physically located in the United States and available during US business hours. Foreign establishments only. All foreign medical device establishments must designate a US FDA Agent before registration can be completed. Domestic establishments do not require a US Agent.
Step 4: Pay the Annual MDUFA Establishment Registration Fee The MDUFA fee must be paid before you can complete the establishment registration submission. You pay through the FDA Device Facility User Fee (DFUF) website, receive a Payment Confirmation Number (PCN), and then use that PCN to finalize registration in the DRLM system. For FY2026, the fee is $11,423. FDABasics prepares your User Fee Cover Sheet and walks you through the payment process so there are no delays. Small businesses with $1 million or less in gross sales may qualify for a hardship waiver. See our Medical Device Registration and Fee Waiver Guide.
Step 5: Register Your Establishment with the FDA Once payment is confirmed, establishment registration is completed through the FDA Device Registration and Listing Module (DRLM). FDABasics handles the entire submission. Registration must be renewed annually between October 1 and December 31.
Step 4: List All Devices Distributed in the US Every medical device distributed in the United States must be listed with the FDA through the DRLM. Device listing must be updated annually and whenever a new device is added or an existing one is discontinued. Device listing confirms what you distribute. It does not constitute FDA approval or clearance of the device. FDAbasics includes this on your Medical Device Registation.
Step 5: Submit UDI Data to GUDID Most medical devices distributed in the US must carry a Unique Device Identifier (UDI) on their labels. UDI data must also be submitted to the FDA Global Unique Device Identification Database (GUDID). FDABasics assists with GUDID account setup and submission.
Step 6: Obtain 510(k) Clearance or PMA Approval if Required Class II devices generally require 510(k) Premarket Notification clearance before US distribution. Class III devices require PMA. Class I devices are generally exempt. FDABasics provides US Agent services for 510(k), PMA, De Novo, HDE, and IDE submissions, and can connect you with trusted consulting partners for full submission preparation.
Step 7: Renew Registration and Device Listing Annually
Medical device establishment registration must be renewed every year between October 1 and December 31. The MDUFA fee must also be paid during this same window. FDABasics tracks your renewal deadline and contacts you before the window opens each year. You do not need to track it yourself.
Who Must Register
Under Section 510 of the FD&C Act, any establishment involved in manufacturing, processing, or distributing medical devices intended for US distribution must register annually with the FDA. This applies to both foreign and domestic establishments.
Establishment types that must register include:
- Medical device manufacturers, Class I, II, and III, foreign and domestic
- In vitro diagnostic (IVD) device manufacturers
- Contract manufacturers and contract sterilization facilities
- Repackagers and relabelers of medical devices
- Single-use device reprocessors
- Specification developers
- US initial importers of foreign-made devices
Foreign establishments must designate a US FDA Agent before registration is complete. Domestic establishments do not require a US Agent but are still subject to annual registration, device listing, and MDUFA fee payment requirements.
If you are a US importer or distributor and are unsure whether registration applies to your specific role, contact us before proceeding.
Medical Device Renewal Dates and Deadlines
| Requirement | Renewal Frequency | Renewal Window | Deadline |
|---|---|---|---|
| MDUFA Establishment Registration Fee | Every year | Oct 1 to Dec 31, every year. Must be paid before registration can be finalized. | December 31 |
| Establishment Registration (foreign and domestic) | Every year | Oct 1 to Dec 31, every year | December 31 |
| Device Listing Update | Every year | Oct 1 to Dec 31, every year. Also update whenever a device is added or discontinued. | December 31 |
FDA Government Fees: Medical Devices (FY2026)
Medical device registration involves a mandatory annual government fee paid directly to the FDA, separate from FDABasics service fees. The fee must be paid before registration can be completed.
| Fee Type | FY2026 Amount | Small Business | Frequency |
|---|---|---|---|
| MDUFA Establishment Registration Fee | $11,423 | Waiver available for businesses with $1M or less in gross sales | Annual, paid before registration |
| 510(k) Standard Fee | $26,016 | $6,504 for qualifying small businesses | Per submission |
| Device Listing | FREE | FREE | Per device, updated annually |
Fees are paid directly to the FDA and change annually each October 1. For the small business waiver, see our Medical Device Registration and Fee Waiver Guide.
Our Services and Fees
| Service | Fee | Need to Know |
|---|---|---|
| Registration and US Agent | ||
| US Agent Services | $299/yr or $250/yr for 2 years upfront | Required for all foreign medical device establishments |
| Establishment Registration (foreign) | $199 | Includes User Fee Cover Sheet preparation |
| Establishment Registration (domestic) | $299 | Annual requirement, completed in 2 business days |
| Device Listing (up to 10 devices) | Included with registration | Required for each device distributed in the US |
| DUNS Number Assistance | $149 | For foreign establishments needing DUNS for MDUFA payment |
| Device Identification | ||
| GUDID / UDI Submission | Contact us for pricing | Unique Device Identification submission to FDA database |
| Premarket Submissions | ||
| US Agent for 510(k), PMA, De Novo, HDE, IDE | Contact us for pricing | We serve as US Agent for premarket submissions; refer to trusted partners for full preparation |
| Labeling | ||
| Medical Device Label Review | Contact us for pricing | Per device labeling package |
Why Medical Device Companies Choose FDABasics
FDABasics has helped foreign and domestic medical device companies with FDA registration since 1995. We handle establishment registration, device listing, MDUFA fee cover sheets, US Agent appointment, annual renewals, and UDI submissions, so your devices stay in good standing with the FDA without any gaps.
- 30+ Years of FDA Regulatory Experience
- Registration Completed in 2 Business Days
- MDUFA User Fee Cover Sheet Preparation Included
- Certificate of Registration Included at No Extra Charge
- 5-Star Rated on Trustpilot and Google
- Transparent, Competitive Fees with No Hidden Charges
- Proactive Annual Renewal Management
- US-Based Team Serving Manufacturers in 100+ Countries
- Strict Client Confidentiality
Frequently Asked Questions
How much does FDA medical device registration cost?
There are two costs: the government fee paid directly to the FDA, and the FDABasics service fee. For FY2026, the annual MDUFA Establishment Registration Fee is $11,423, paid to the FDA before registration is completed. FDABasics service fees are listed above. Small businesses with $1 million or less in gross sales may qualify for a hardship waiver of the FDA fee.
Do I need to pay the FDA fee before I can register?
Yes. For medical devices, the MDUFA establishment registration fee must be paid before the registration submission can be completed. You pay through the FDA Device Facility User Fee website, receive a Payment Confirmation Number, and use that number to finalize registration. FDABasics prepares your User Fee Cover Sheet and guides you through this process as part of our registration service.
Do I need a 510(k) to sell my medical device in the United States?
Most Class II medical devices require 510(k) clearance before US distribution. Class I devices are generally exempt. Class III devices require Premarket Approval (PMA). Search the FDA device classification database at accessdata.fda.gov to confirm your device class. FDABasics provides US Agent services for 510(k) submissions and can refer you to trusted consulting partners for full preparation.
Does a foreign medical device manufacturer need a US FDA Agent?
Yes. Every foreign establishment that manufactures or processes medical devices for the US market must designate a US Agent physically located in the United States. The US Agent must be listed in your establishment registration and is the FDA's point of contact for inspections, correspondence, and regulatory matters. Domestic establishments do not require a US Agent.
Do US importers and distributors of medical devices need to register?
US initial importers of foreign-made medical devices are generally required to register with the FDA. Domestic distributors may also be required to register depending on their activities, particularly if they are responsible for labeling or other regulated functions. Contact us if you are a distributor or importer and are unsure whether registration applies to your role.
What happens if I do not renew my FDA medical device registration?
If the MDUFA fee is not paid and registration is not renewed by December 31, your establishment registration becomes inactive. Devices cannot be legally distributed or imported into the United States, and new device applications cannot be submitted to the FDA until registration is reactivated. FDA does not grant extensions.
Ready to Register? Start With These Top Medical Device Forms
- US Agent for Foreign Establishment Registration Form
- Medical Device Registration Form
- GUDID / UDI Submission (Contact Us for More Info)
Other Services and Resources
PRE MARKET NOTIFICATION 510 (K)
Some Class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.
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