Frequently Asked Questions

Responsibilities of a U.S. agent  The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.

The responsibilities of the U.S. 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 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.

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).

User Fees for FY2022 Annual Establishment Registration Fee:  $5,672

All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups.

Other fees for Fiscal Year 2022 (October 1, 2021 through September 30, 2022) are in following link
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa

 The FDA will complete its review of the Small Business Certification Request within 60 calendar days of receipt. Upon completion of our review, we will send the business a letter that indicates whether or not the business has been qualified as a small business. 

 There is no fee associated with the submission of a Small Business Certification Request.