Accessing the US medical device market requires manufacturers to comply with several FDA obligations. One of the essential steps – after determining your device access pathway and receiving approval – is to register your company (establishment) and list your devices with the FDA.
What is establishment registration?
All manufacturers (including relabellers) of medical devices must register their business with the FDA. This process is known as establishment registration, and it is mandatory before any device can be legally marketed in the US.
Essentially, the following applies:
- The registration applies to both domestic and foreign manufacturers.
- Each registration must be renewed annually, along with the payment of the FDA registration fee.
- Foreign manufacturers must also appoint a US Agent, to serve as their official contact with the FDA.
What is device listing?
In addition to registering your establishment, you must also list each medical device you intend to sell in the US market.
- Listing is done through the FDA’s online FURLS system.
- Each device is linked to its classification and regulatory pathway:
Listing your device also involves selecting appropriate product codes, which indicate its intended use and risk profile.
How Obelis US can help you
Navigating the US FDA system can be complex, especially for foreign manufacturers. Obelis US supports medical device companies in meeting their compliance obligations by offering:
- U.S. Agent services: acting as the official FDA contact.
- Establishment registration & device listing: performing establishment and product registration on FURLS system.
- Regulatory pathway guidance: assisting with the right classification and the respective regulatory access pathway of a device.
- Ongoing compliance support: ensuring that our clients stay up to date with a constantly changing regulatory landscape.
- Support with FDA submissions: supporting manufacturers of medical devices with preparing the documentation for the FDA approval.
Looking to sell your device in the US? Let Obelis US help you take the right first steps. Contact us today to ensure your registration and listing are done right.
Georgios Mariolos
Regulatory Intelligence and Innovation Junior Consultant
16/07/2025
References:
US Food & Drug Administration (2024). Device Registration & Listing. Retrieved on 16/07/2025
US Food & Drug Administration (2024). How to Register & List. Retrieved on 16/07/2025
US Food & Drug Administration (2018). Who Must Register, List and Pay the Fee. Retrieved on 16/07/2025
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