21 CFR Part 807 requires any business that makes, imports, repackages, relabels, or specifies a medical device for the U.S. market to register each facility with the FDA and list every device it handles. Registration and listing are submitted electronically through the FDA Unified Registration and Listing System (FURLS), the annual establishment fee for fiscal year 2026 is $11,423, and renewal runs every year between October 1 and December 31. Skip the requirement and your devices are treated as misbranded under federal law.
Who Has to Register and List
The rule reaches most of the supply chain between a device’s design and its delivery to a U.S. patient. You are covered if your business falls into any of these categories:
- Domestic manufacturers producing a finished device at a U.S. facility.
- Foreign manufacturers producing devices imported or offered for import into the United States.
- Contract manufacturers who build devices for another company, even without selling under their own name.
- Specification developers who own the design and hand off production. A specification consultant who does not control the design is not covered.
- Repackagers and relabelers who change the packaging or the labeling content after the original manufacturer shipped the device. Simply adding your store name to existing labeling, without altering the content, does not count.
- Initial importers, meaning the first U.S. business to take ownership of a foreign-made device brought in for commercial sale.1FDA. Who Must Register, List and Pay the Fee
The obligation attaches to the facility, not the corporation. Three plants means three registrations and three fees.
Who Is Exempt
Several categories of business touch devices but sit outside Part 807, under 21 CFR 807.65.2eCFR. 21 CFR 807.65 – Exemptions for Device Establishments Licensed physicians, dentists, and optometrists who make or modify devices solely for use in their own practice are exempt. Pharmacies and retail outlets that sell to the end user, including under a store brand, are exempt as long as they do not alter the labeling content. Suppliers of components and raw materials are exempt because the finished-device manufacturer carries the registration. Research-only manufacturers whose devices never enter commercial distribution, carriers who transport devices, hearing aid dispensers, opticians, clinical laboratories, and companies producing devices only for animal use are also excluded.
The word doing the work in most of these exemptions is “solely.” A dentist who modifies devices for other offices, or a research manufacturer that starts commercial sales, loses the exemption. Wholesale distributors are outside the rule while they only store and transport, but the moment they repackage or relabel, they cross into a regulated activity and must register.
What the Submission Has to Contain
Registration identifies the facility. Listing identifies the devices. Both go in.
Facility Information
For each physical location you provide the business name, address, and contact details, and you identify the owner or operator and an Official Correspondent. The Official Correspondent manages the registration and listing data in FURLS and receives FDA communications about compliance.3FDA. How to Register and List
U.S. Agent for Foreign Establishments
A foreign manufacturer must also designate a U.S. Agent who lives in the United States or maintains a U.S. place of business. A mailbox or answering service does not qualify. The agent’s name, address, phone number, and email must be entered during registration, and the agent handles FDA questions about the foreign company’s devices and helps coordinate inspections.4FDA. U.S. Agents
Device Information
For each device you list, 21 CFR 807.25 requires:5eCFR. 21 CFR 807.25 – Information Required for Device Listing
- The three-letter FDA product code identifying the generic category. Look it up in the Product Code Classification Database.6FDA. Product Code Classification Database
- The proprietary or brand name you market it under.
- The premarket submission number, if the device required a 510(k), PMA, De Novo, or humanitarian device exemption.
- The activities your facility performs, such as manufacturing, repackaging, relabeling, contract sterilizing, or importing.
Missing or wrong product codes and blank submission numbers where one is required will slow your registration and prompt follow-up from the FDA.
How to Submit Through FURLS
Everything moves through FURLS, specifically its Device Registration and Listing Module (DRLM), at access.fda.gov. The order matters, because payment has to happen before registration will go through:
- Pay the establishment registration fee through the FDA’s Device Facility User Fee portal. You receive a Payment Identification Number (PIN) and a Payment Confirmation Number (PCN).
- Create the FURLS account for the owner or operator and enter the Owner/Operator and Official Correspondent information.
- From the DRLM main menu, select “Register a Medical Device Facility” and enter the facility details.
- Enter each device with its product code, brand name, activities, and any premarket submission number.
- Enter the PIN and PCN at the end. Without them, the FDA will not treat your registration as complete.3FDA. How to Register and List
Deadlines
A new establishment must complete its initial registration within 30 days of beginning operations or first putting a device into commercial distribution.7eCFR. 21 CFR 807.22 – Times for Registration and Listing After that, you renew every year between October 1 and December 31, and you review and update your device listings during the same window even if nothing has changed.8FDA. When to Register and List Missing the window is what most often causes an “inactive” status in the public database.
Fees and the Small-Business Question
The annual establishment registration fee for fiscal year 2026 is $11,423, adjusted each year under the Medical Device User Fee Amendments.9Federal Register. Medical Device User Fee Rates for Fiscal Year 2026 It is charged per establishment, so multiple facilities means multiple fees. There is no separate listing fee.
The FDA’s Small Business Determination program helps with premarket submissions, not with the establishment fee. Businesses with gross receipts or sales not exceeding $100 million qualify for reduced 510(k) and PMA fees, and companies under $30 million can have their first premarket submission fee waived. A registration fee waiver exists only for businesses with gross receipts of $1 million or less that can demonstrate financial hardship and have paid the registration fee at least once before.10FDA. Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program A startup should plan on paying the full fee from year one.
What Happens If You Don’t Register
A device made at an unregistered facility is misbranded under Section 502(o) of the Federal Food, Drug, and Cosmetic Act, as is a device that is not properly listed.11Office of the Law Revision Counsel. 21 USC 352 – Misbranded Drugs and Devices Introducing a misbranded device into interstate commerce is a prohibited act, which can support criminal prosecution.12Office of the Law Revision Counsel. 21 USC 331 – Prohibited Acts
The administrative consequences usually bite first. For foreign manufacturers, the FDA commonly uses “detention without physical examination,” refusing entry to every shipment from the facility at the border until the violation is fixed. For domestic operations, a warning letter typically follows an inspection and cites the registration failure alongside other findings.
The knock-on effects reach further than shipments. The FDA will not accept 510(k) or PMA submissions from an unregistered establishment, will not sign Certificates to Foreign Governments, and will not accept device listings in FURLS. A company’s entire product pipeline can sit frozen until it registers and clears the outstanding fees, and the cost of that hold usually dwarfs the fee that was being avoided.
Registration Is Not Premarket Clearance
Registering a facility does not clear a device for the market, and clearing a device does not register the facility. You need both. The FDA checks compliance with registration, listing, and applicable premarket requirements when devices enter the country.13FDA. Importing Medical Devices When you list a device that required a 510(k), PMA, De Novo, or humanitarian device exemption, the submission number has to appear in the listing.
Checking Your Status
The FDA publishes registration and listing data in a public Establishment Registration and Listing database.14FDA. Search Registration and Listing Anyone can confirm whether a facility is active for the current fiscal year, and hospitals, distributors, and group purchasing organizations use it to check suppliers before placing orders. If your own status reads inactive, the usual cause is a missed renewal or unpaid fee during the October-through-December window; log in to FURLS, complete the renewal, and pay to restore active status.