Registration and Listing / U.S. Agent
Registration and listing provides FDA with the location of medical device establishments and summary information about the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
Any foreign establishment must identify a single United States agent (U.S. Agent) for that establishment. Information about a foreign establishment’s U.S. Agent (name, address, telephone and fax numbers, and e-mail address) is part of the establishment registration process. The U.S. Agent must reside in the U.S. or maintain a place of business in the U.S.
All places of business (establishments or facilities) involved in the design, production or distribution of medical devices intended for use in the United States are required to register annually with the FDA. This annual registration incurs an annual establishment registration fee for each establishment or facility involved in the design, production, or distribution of medical devices marketed in the U.S. Registration is based on the FDA fiscal year (October 1 through September 30) and the fee amount is determined annually. The fee reduction enjoyed by companies with an FDA-issued Small Business Determination does not apply to the annual registration fee; all establishments and facilities pay the identical fee for registration with FDA.
All medical devices marketed in the U.S. must be listed with FDA in association with a registered establishment. FDA has defined establishment types and has identified which of these establishment types are required to list associated devices, and the activities that are performed on those devices. For devices that require premarket approval or notification prior to legal marketing in the U.S., the listing activity requires that the applicable premarket submission number be provided.
U.S. Agent / Official Correspondent
The U.S. Agent has limited responsibilities that are outlined below. Note that the U.S. Agent has no FDA requirement for 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). However, KBC can assist with these additional activities outside of the U.S. Agent responsibilities.
A foreign company may choose to have the U.S. Agent also act as the Official Correspondent. The official correspondent is the person designated by the company to be the initial point of contact between FDA and the company. The responsibilities of the Official Correspondent are defined in FDA regulations and are listed below.
Responsibilities - U.S. Agent:
- 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, and
- 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.
Responsibilities - Official Correspondent [21 CFR 807.3(e)]
Official correspondent means the person designated by the owner or operator of an establishment as responsible for the following:
- The annual registration of the establishment,
- Contact with the Food and Drug Administration for device listing,
- Maintenance and submission of a current list of officers and directors to the Food and Drug Administration upon the request of the Commissioner, and
- The receipt of pertinent correspondence from the Food and Drug Administration directed to and involving the owner or operator and/or any of the firm's establishments.