Who Must Register and List Medical Devices with the FDA?

Understand which medical device establishments must register and list with the FDA. From manufacturers and importers to contract service providers, learn the requirements, exemptions, and why proper registration is essential for legal U.S. marketing.

Not every business that handles a medical device has to register with the FDA – but most that manufacture or commercially distribute devices in the U.S. do. FDA’s regulations (21 CFR Part 807) spell out exactly which types of establishments must register and list, and which are exempt. Below is an overview of who must register/list versus who does not:

• Medical Device Manufacturers: If you manufacture a medical device (including fabrication, assembly, or processing of a finished device), you must register your establishment and list your devices. This includes manufacturers of Class I, II, or III devices, whether you sell in the U.S. or export (for U.S. firms, even if exporting only, and for foreign firms exporting to the U.S.). Manufacturers of accessories or components that are sold directly to end users as medical devices are also required to register and list. Even makers of custom devices or kit assemblers are not off the hook – they count as manufacturers in FDA’s eyes and must register.
• Contract Manufacturers & Contract Sterilizers: Firms that make devices under contract for another company, or that sterilize devices for another company, are required to register and list as well. FDA changed the requirements in 2012 to ensure even those who do not put the device into final commercial distribution (e.g. they return it to the spec developer) still register and list. So if you are a third-party manufacturer or a sterilization service for devices, you have the same obligations.
• Specification Developers: If your company designs and develops the specifications for a device and then has it made by someone else (often called a “virtual manufacturer”), you are considered a specification developer. Specification developers must register and list their devices, even if they outsource 100% of the production. The contract manufacturer would register/list as well, but the device must first be listed by the spec developer or primary manufacturer.
• Repackagers and Relabelers: Companies that take a finished device from the original manufacturer and repackage or relabel it for further distribution under their own name must register and list. For example, if you buy bulk devices and repackage them into smaller units, or if you affix your own brand labeling, you fall in this category and have to register.
• Initial Importers: An initial importer is defined as the first U.S. company that takes ownership of a device imported from a foreign manufacturer and places it into U.S. distribution. Initial importers are required to register their establishment with FDA. However – importantly – initial importers are not required to list devices. Instead, they must identify the manufacturer and the manufacturer’s listing for the devices they import. FDA’s logic is that the foreign manufacturer will have listed the device; the importer just needs to be registered as an entry point. (The initial importer still must meet other requirements like complaint handling, etc., but those are outside our scope here.)
• Foreign Manufacturers and Exporters: Any foreign establishment that manufactures medical devices for import into the U.S. must register and list, just like domestic manufacturers. Additionally, foreign companies must designate a U.S. Agent (covered in a later section). Note that foreign exporters who export devices to the U.S. (even if they didn’t manufacture them) are also required to register/list. FDA wants accountability for any overseas firm sending devices into the U.S. supply chain.

Who is exempt from registration?

FDA provides some notable exemptions:

• Distributors (Non-importing): A domestic wholesale distributor that only distributes devices within the U.S. and does not manufacture, repackage, or relabel them typically does not have to register. For instance, a medical supply distributor who buys finished, FDA-cleared devices and sells them to clinics, without rebranding or altering them, is generally exempt from establishment registration. (They are not performing manufacturing activities and the manufacturer is the one who registered/listed.)
• Retailers: Similarly, retail pharmacies or durable medical equipment stores that sell devices to end users are not required to register, as they’re considered final point-of-sale providers, not device manufacturers.
• Manufacturers of Components for OEMs: If you make components that are not finished devices and you sell them only to a manufacturer who incorporates them into a finished device, you are exempt from registering for that activity. The idea is that the final device manufacturer will handle the registration and listing. (However, if you label/market your component as a standalone device or accessory to end users, then you’re no longer exempt – you’d be a device manufacturer in that scenario.)
• Import agents or brokers who do not take possession of the device, and other parties who don’t actually own or physically handle the device, are not required to register. For example, a freight forwarder or customs broker doesn’t register because they aren’t considered an “establishment” in device production or distribution.
• Service providers like testing labs, consultants, or software developers (unless the software is itself a medical device) generally do not register, since they aren’t “establishments” introducing a device into commerce.

It’s worth noting that some categories can be confusing. For instance, companies that only handle device complaints (but don’t manufacture) were historically registered as manufacturers or spec developers; FDA now has a specific category called “Complaint File Establishment” for such cases, which clarifies their role. Also, if you’re a contract manufacturer making a device and also the specs-owner markets it under their name, both entities register and list, but the device listing is typically initiated by the brand owner.

Key takeaway

If you touch the device in a way that affects its manufacturing, labeling, or import status, you likely need to register. Most companies new to FDA regulations should assume they need to register and list, unless a clear exemption applies. When in doubt, consult FDA’s “Who Must Register” charts or guidance (or ask a regulatory expert) to confirm. It’s safer to register unnecessarily than to fail to register when you were supposed to – as failing to register can lead to serious compliance violations (discussed later).

Lastly, remember that registration and listing are an establishment’s responsibility. Even if multiple parties are involved with a device (e.g. a foreign maker, U.S. spec developer, contract sterilizer, importer), each must fulfill their own registration duties. FDA’s database will link these related listings together (e.g. an importer identifies the foreign manufacturer’s listing), creating a complete picture of the supply chain. The next section will explain how to carry out the registration and listing process step by step.

Two Requirements, One Common Mistake

Ask most medical device startup founders whether their company is registered with the FDA, and they will confidently say yes. Ask whether their devices are properly listed, and the conversation gets uncomfortable fast. These are two distinct, legally required obligations under 21 CFR Part 807, and conflating them — or completing one without the other — puts your entire commercial operation at risk.

At ADB Consulting and CRO Inc., we see this gap constantly, particularly among early-stage device companies that are moving quickly from development into commercialization. This post breaks down exactly what each requirement entails, where companies go wrong, and what you need to do to stay on the right side of FDA enforcement.

What Is FDA Establishment Registration?

Establishment registration is the process by which your facility — not your product — is formally identified with the FDA. Under 21 CFR Part 807, Subpart B, any domestic manufacturer, specification developer, single-use device reprocessor, or distributor who repackages or relabels devices must register their establishment with the FDA annually.

Foreign establishments that export devices to the United States are subject to the same requirement under 21 CFR 807.40. Registration is completed through the FDA Unified Registration and Listing System (FURLS), specifically the Device Registration and Listing Module (DRLM). The annual registration period runs from October 1 through December 31, and fees apply to most device establishments. For fiscal year 2025, the standard registration fee is set by FDA and subject to annual adjustment — confirm the current amount directly on FDA.gov before submitting.

What registration does is simple: it tells the FDA who you are and where you operate. It does not authorize you to market any specific product. That is where device listing comes in.

What Is Device Listing?

Device listing is the separate, concurrent obligation to notify the FDA of the specific devices your establishment manufactures or distributes. Per 21 CFR 807.20 and 807.25, listing must be submitted at the time of initial registration and updated within 30 days of any changes — including adding new devices, discontinuing products, or modifying device names.

Each listed device must be assigned the correct FDA Product Code, which maps to the device classification under 21 CFR Parts 862 through 892. Selecting the wrong Product Code is one of the most common technical errors we see — and it can trigger an automatic rejection or, worse, go unnoticed until an inspection reveals the discrepancy.

Device listing is not a clearance or approval. You are not asking the FDA for permission to market your device through the listing process. You are providing mandatory transparency about what products are associated with your registered facility. The actual pathway to market — 510(k), De Novo, PMA, or exempt status — is a separate determination entirely.

Why You Need Both — And Why They Are Not Interchangeable

Registration without listing means you have a facility on record but no devices tied to it. Listing without registration is structurally impossible — FURLS will not permit device listing for an unregistered establishment. But the more nuanced failure mode is submitting both incompletely or inaccurately.

Under Section 510 of the Federal Food, Drug, and Cosmetic Act and the implementing regulations in 21 CFR Part 807, failure to register or list is a prohibited act. It can result in:

• FDA refusal to accept premarket submissions (510(k), PMA) from your establishment
• Import alerts for foreign establishments
• Warning letters and potential injunctive action
• Seizure of devices that are commercially distributed without proper listing

FDA publishes the list of registered establishments and listed devices publicly, and you can verify an FDA registration directly in that database. Hospitals, distributors, and international regulatory bodies routinely search this database during supplier qualification. If your establishment does not appear — or your device is not listed — you may lose commercial contracts long before FDA takes formal enforcement action.

Common Pitfalls We See in Practice

Several patterns appear repeatedly in our regulatory consulting engagements:

• Missing the annual renewal window: Registration must be renewed each year between October 1 and December 31. Missing this window results in lapsed registration status, which can block 510(k) acceptance.
• Incorrect establishment type selection: Manufacturers, contract manufacturers, specification developers, and distributors have different registration obligations. Choosing the wrong type creates compliance gaps.
• Listing exempt devices incorrectly: Class I exempt devices still require listing in most cases under 21 CFR 807.65. Exemption from 510(k) is not the same as exemption from listing.
• Failing to update listings after product changes: New product iterations with different indications or product codes require updated or new listings within 30 days of commercial distribution.
• Overlooking contract manufacturer obligations: If you outsource manufacturing, both your specification developer establishment and your contract manufacturer may have independent registration and listing obligations.

How to Approach This Correctly From Day One

The registration and listing process is procedurally straightforward — but strategically, it requires getting the foundational elements right from the outset. That means correctly classifying your device, selecting the accurate Product Code, determining your establishment type, and understanding whether a premarket pathway is required before distribution begins.

For companies expanding internationally, keep in mind that FDA registration does not satisfy Health Canada Medical Device Establishment License requirements, EU EUDAMED obligations under the MDR, or country-specific requirements in other markets. Each jurisdiction has its own parallel framework.

Building a compliant registration and listing structure early — rather than retrofitting it during a regulatory inspection or M and A due diligence — is always the less expensive path.

Work With a Regulatory Partner Who Gets It Right

At ADB Consulting and CRO Inc., we provide an FDA device registration and listing service that helps medical device startups and growing companies navigate both requirements accurately and efficiently. Whether you are registering for the first time, cleaning up legacy compliance gaps, or preparing for a product launch, our team provides the regulatory expertise to get it done right.

Do not let a preventable administrative error stall your 510(k) submission or block your commercial launch. Book a free discovery call with Andre Butler and the ADB Consulting team today at adbccro.com. Let us build your regulatory foundation the right way.

Frequently Asked Questions

Who must register a medical device establishment with FDA?

Under 21 CFR Part 807, manufacturers, specification developers, repackagers, relabelers, initial importers, and foreign exporters to the U.S. must register their establishment with FDA and list their devices. Registration applies to both domestic and foreign facilities.

What is the difference between device registration and device listing?

Device registration identifies the establishment (company and facility) with FDA — the "who" and "where." Device listing identifies the specific devices manufactured or imported — the "what." Both are required simultaneously through FDA's FURLS system.

Who is exempt from FDA device establishment registration?

Domestic distributors who do not manufacture, repackage, or relabel devices, retail sellers, component manufacturers who sell only to OEMs, import brokers, and service providers (labs, consultants) are generally exempt. If in doubt, assume registration is required and confirm with FDA guidance or a regulatory consultant.

Do foreign device manufacturers need to register with FDA?

Yes. Foreign establishments that manufacture medical devices for import into the U.S. must register with FDA and list their devices, just like domestic manufacturers. Foreign establishments must also designate a U.S. Agent before completing registration.