Establishment registration is a core FDA requirement for device firms. Learn who must register, how the process works, common misconceptions, and why annual registration and device listing are essential to legally market medical devices in the U.S.
Establishment registration is a mandatory step for any facility involved in the production or distribution of medical devices intended for U.S. commercialization. In simple terms, if you manufacture, prepare, propagate, assemble, or import medical devices for sale in the United States, you are required to register your establishment annually with the FDA. This applies to both domestic U.S. companies and foreign manufacturers exporting to the U.S. market. It’s important to understand that registration is different from product approval – it does not imply FDA “approval” of your device, but rather it’s a way of notifying FDA of your location and the devices you are handling. In fact, FDA explicitly does not issue any certificate or “FDA registration” seal upon registration, and firms should not misrepresent registration as an endorsement.
FDA establishment registration is one of the General Controls that apply to all medical devices under the law. It provides FDA with a current inventory of who is manufacturing or importing devices.
Legality: Marketing a device without proper registration is illegal – devices made in an unregistered facility are considered misbranded under U.S. law. Registration is also a prerequisite for other regulatory actions: for example, FDA will not process a new 510(k) submission or issue certain certificates for a company that has not fulfilled its registration and listing obligations. In short, establishment registration is essential to legally market your device and maintain good standing with FDA.
You’ll often hear “registration and listing” together. These are related but distinct requirements. Establishment registration identifies your company/facility with FDA, whereas device listing identifies the specific products (devices) you manufacture or import. All required establishments must do both – register the company and list their devices (with a few exceptions such as some importers, covered later). We’ll delve deeper into device listing in a later subtopic, but at the basic level: registration is about the “who” and “where,” listing is about the “what”. Both steps are usually completed in the FDA’s online FURLS system as part of the same overall process.
The FDA maintains an online system called the FDA Unified Registration and Listing System (FURLS) (specifically the Device Registration and Listing Module, DRLM) for electronic submission of registration info. Companies must first pay an annual user fee (more on the fee in a later section), then log into FURLS to submit establishment details and device information. Upon successful submission, the establishment is assigned a registration number, and each device listing is assigned a listing number in FDA’s database. You will receive an email confirmation once all requirements are met. It’s important to note that FDA’s confirmation of registration is not an approval letter – it simply means your establishment is now on record for the current fiscal year.
New device companies often have misconceptions about FDA registration. One common myth is the idea of being “FDA certified” or receiving an official certificate. In reality, FDA does not certify medical device facilities or issue any registration certificate. Your entry in the FDA’s public registration database is purely a record of compliance, not an endorsement of the facility or products. Another mistake is assuming that registration is a one-time event. In fact, registration must be renewed every year with payment of the annual fee, and device listings must be updated regularly (or at least verified annually). Failing to renew on time can lead to your registration being invalid and your devices being illegally marketed unknowingly.
In summary, establishment registration is a foundational FDA requirement for device manufacturers and other device-related firms. It’s a straightforward process, but it carries serious weight – it’s the gateway to legally selling your product in the U.S. and a key part of FDA’s oversight. Understanding these basics sets the stage for compliance and helps you avoid regulatory pitfalls from the outset.
