According to U.S. FDA medical device regulations all medical device establishments that develop, manufacture, pack, assemble, label, export or import medical devices are required to Register with FDA (FDA Device Establishment Registration) and pay an annual FDA user fee that is 7,653 USD for the year 2024. The registered medical device establishment must also list all of their medical devices individually (FDA Device Listing) prior to commercial distribution in the U.S. market. Aside from device establishment registration and device listing, all medical device firms that are located outside U.S. are required to appoint a official correspondent, or U.S. agent, as FDA’s primary point of contact before importing into the United States.
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.
The U.S. agent may be called upon to speak with FDA in regards to the foreign registered facility. This can be a time-sensitive matter. As a result, it is crucial that the U.S. agent understands the FDA regulations and is able to advise the foreign establishment on FDA medical device requirements that must be followed. Furthermore, having an independent U.S. agent will prevent a potential conflict of interest that can appear when assigning a business partner as U.S. Agent.
FDA Listing Inc. provides FDA medical devices establishment registration and medical device Listing and can act as U.S. FDA Agent to Non-US companies that are already in the market or intending to enter the U.S. market.
Click the front start button for medical devices establishment registration and device listing.
The responsibilities of the FDA US agent are limited and include:
- Assisting FDA in communications with the foreign establishment.
- Responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States.
- Assisting FDA in scheduling inspections of the foreign establishment.
If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).
After your registration is complete, the registered medical device establishment will be allocated with a FDA registration number from FDA. The FDA registration number will identify your company with FDA as well as assist you in the custom clearance process. U.S. FDA does not issue any registration certificate however, as a third party firm, FDA Listing Inc. will provide you with a certificate of FDA registration that can be used as FDA registration confirmation. The FDA registration certificate is good for one year and the copy of the FDA registration certificate can be used as a proof of registration before U.S. custom, importers, distributers and other commercial outlets.
