Flat-Fee Self-Service · Step 3 of 3
Every establishment that manufactures, imports, or distributes medical devices for the US market must register with FDA and list its devices — and renew annually between October 1 and December 31. ADB handles the entire process for a published flat fee. FDA's annual establishment registration user fee is set by FDA each fiscal year and paid separately, directly to FDA.
Get Started TodayThe Complete Registration Path
Registration is Step 3. Understand where your device stands in the sequence — then skip to the pricing table below if you already know you're ready to file.
Step 1
FDA registration starts with the right product code. We identify your device's FDA class (I, II, or III), the specific product code from FDA's classification database, and whether your device qualifies as 510(k) exempt. Getting this step right determines everything that follows — the wrong product code can mean a 510(k) clearance requirement you didn't know about, or a clearance you skipped that you actually needed.
If your device's classification is genuinely uncertain — novel intended use, dual-class technology, or a device-drug-biologic combination — we file a 513(g) Request for Classification to obtain FDA's written determination before committing to a development program. A 513(g) response is the most reliable classification anchor you can have going into registration.
Covered: FDA product code identification · Class I / II / III determination · 510(k) exempt status analysis · 513(g) filing when classification is ambiguous · Regulatory class documentation for audit readiness
Step 2
510(k) exempt devices skip this step entirely — once classified, they proceed directly to registration. For Class II devices that are not exempt, we manage your 510(k) submission: predicate device selection, substantial equivalence argument, performance testing planning, and eSTAR package compilation through FDA clearance.
For novel devices without a predicate, we build the De Novo classification request. For Class III devices, we develop the PMA strategy aligned to the specific review division. Where the device is software-based or connected, we incorporate Section 524B cybersecurity documentation into the submission package.
Covered: 510(k) exempt documentation · 510(k) submission management · De Novo classification request · PMA strategy for Class III devices · Predicate selection and substantial equivalence analysis · Section 524B cybersecurity documentation
Step 3
With classification confirmed and any required clearance in hand, we complete your FDA establishment registration in FURLS: account setup, establishment information, FDA device listing requirements — product codes, submission numbers, and listing entry management. Annual renewal is included — we track the October 1–December 31 renewal window and handle the submission so your registration never lapses.
This is the step available as a standalone flat-fee service. See the pricing table below to select your package.
Covered: FURLS account creation and setup · Establishment registration submission · Device listing with product codes · Annual renewal management · Listing updates for new products, changes, and discontinuations · Foreign establishment US Agent designation
Under 21 CFR Part 807, any domestic or foreign establishment that manufactures, repackages, relabels, or sterilizes medical devices for distribution in the United States must register with FDA and pay the annual establishment registration user fee. The requirement applies regardless of device class — Class I, II, and III devices all require establishment registration. Initial importers must also register. Distributors who do not alter the device or its labeling are generally exempt, but repackers and relabelers who change packaging or labeling must register.
Foreign manufacturers are subject to the same registration requirements as domestic manufacturers and must additionally designate a US Agent residing or maintaining a place of business in the United States. The US Agent serves as FDA's point of contact for the establishment, receives correspondence on the establishment's behalf, and must be reachable by FDA at all times. ADB provides US Agent services for foreign establishments as a standalone annual engagement or bundled with the Full-Service Registration tier.
Device listing is the companion requirement to establishment registration. Every device manufactured or imported by a registered establishment must be listed in FDA's FURLS system with its product code — a three-letter identifier drawn from the 21 CFR Parts 862–892 classification regulations. The product code determines the device's regulatory class (I, II, or III) and its pre-market submission status: exempt, cleared (510(k)), classified (De Novo), or approved (PMA). For a detailed walkthrough of the listing process and FDA device listing requirements, see our dedicated service page.
Registration must be renewed annually between October 1 and December 31. FDA does not send renewal reminders — the establishment is responsible for tracking the window. Establishments that miss the renewal deadline have their registration suspended on January 1, and their devices become subject to refusal of admission at US ports of entry until renewal is completed and the user fee is paid. Device listings must be updated within 30 days whenever a new device is introduced, a listed device is discontinued, or a change affects the product code or submission status.
Published Pricing
Fixed fees — no hourly billing surprises. FDA's annual establishment registration user fee is set by FDA each fiscal year and paid separately, directly to FDA.
Full-Service Registration — One Payment, Zero FDA Accounts
Invoiced as one total via ACH bank transfer — no card fees on the FDA portion.
If we can't complete your registration, our $795 service fee is refunded in full — and any unremitted FDA fee funds are returned immediately.
Establishment Registration + Device Listing
flat fee · first device
FDA annual user fee paid separately to FDA.
US Agent / Official Correspondent Service
per year · foreign establishments
Full US Agent service details →
Running a US clinical study? You may also need a US Sponsor of Record — a separate engagement under 21 CFR Part 812.
Registration + Listing + US Agent Bundle
flat fee · Year 1 · foreign establishments
FDA annual user fee paid separately to FDA.
UDI / GUDID Entry
per device
Registrations handled by senior FDA regulatory consultants — not a call center. Learn about our team.
What Happens After You Purchase
From first payment to registered establishment — here's exactly what to expect.
Purchase & Intake
Pay, complete the intake form, and receive your kickoff email and status-page link the same business day.
Kickoff
Your consultant confirms your establishment details and device information. Full-Service clients receive their single ACH invoice.
FDA Fee
Full-Service: we remit to FDA once funds clear and send the Pay.gov receipt and Payment Confirmation Number. Self-service: we guide you through DFUF and Pay.gov.
Registered & Listed
Establishment registered and device listed in FURLS/DRLM. Registration number and FEI confirmed.
Confirmation Packet
Certificate, registration and listing numbers, FEI, receipts, and your annual renewal calendar (renewals run October 1–December 31).
Typical timeline for domestic clients with complete information; international wire transfers can add 3–5 business days.
Registrations are handled personally by a senior FDA regulatory consultant. Learn about our team.
Get Started
Submit your details and we'll confirm the right package and next steps within one business day.
Sending your request…
Common Questions
ADB's flat fee for establishment registration plus first device listing is $795. Additional device listings are $95 each. FDA's annual establishment registration user fee is set by FDA each fiscal year and is paid separately, directly to FDA — not to ADB. The annual fee amount changes year to year and is not included in our service fee.
Yes. Every establishment that manufactures, imports, or distributes medical devices for the US market must register with FDA and list its devices before commercial distribution. Establishments must renew their registration annually between October 1 and December 31. Failure to register is a prohibited act under Section 301 of the FD&C Act and can result in import detention, warning letters, and injunctions.
No. FDA establishment registration and device listing are administrative requirements — they confirm your establishment is in FDA's database and that your device is associated with a product code and listing entry. They do not substitute for pre-market clearance or approval. If your device requires a 510(k), De Novo classification, or PMA before it can legally be marketed, registration does not waive that requirement. See Step 2 of our framework for submission preparation services.
Yes. Every foreign establishment required to register with FDA must designate a US Agent residing or maintaining a place of business in the United States. The US Agent receives FDA correspondence on behalf of the foreign establishment and must be reachable by FDA at all times. ADB provides US Agent and Official Correspondent services for $595 per year, including annual renewal management.
For domestic establishments with an exempt device and complete information, registration and listing can typically be completed within a few business days of receiving all required details. More complex situations — foreign establishments, devices requiring product code verification, or establishments undergoing initial FURLS account setup — may take slightly longer. We'll give you a realistic timeline after reviewing your device and establishment information. Once complete, you can verify your registration status at any time with our free FDA registration lookup tool.
UDI (Unique Device Identification) is FDA's system for tracking medical devices through distribution and use. Most devices distributed in the US must have a UDI and a corresponding record in FDA's GUDID (Global Unique Device Identification Database). The requirement applies to most Class II and Class III devices, with Class I devices phased in on a schedule. ADB handles GUDID account setup, device identifier (DI) record creation, and label data submission for $395 per device.
Yes. The Full-Service Registration tier collects one ACH payment covering our $795 service fee and FDA's FY2026 establishment fee of $11,423. Once your funds clear, we remit directly to FDA via Pay.gov and provide you with the Payment Confirmation Number and Pay.gov receipt. Alternatively, our standard Registration + Listing package includes step-by-step guidance to pay FDA directly yourself.
Any domestic or foreign establishment that manufactures, repackages, relabels, or sterilizes medical devices for US distribution must register with FDA and pay the annual user fee.
The registration window opens October 1 and closes December 31 each year. New establishments must register before beginning commercial distribution.
The FY2026 annual establishment registration fee is $11,423. ADB's flat-fee registration service ($795) covers your FURLS submission and device listing — the FDA user fee is paid separately by the manufacturer.
Not Sure Where to Start?
We assess your device's current regulatory status and tell you exactly where you stand — classification, clearance, and registration — in a free strategy call.