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.

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.