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:
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
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.
A Small Business Certification is granted for a Fiscal Year and expires at the end of that Fiscal Year. A sponsor who wishes to apply any applicable reduction in user fee for a submission must apply and be granted the Small Business Certification for each Fiscal Year in which they plan to submit a medical device application that requires a user fee. A Fiscal Year runs from October 1 through September 30 of the following year. For example, Fiscal Year 2021 runs from October 1, 2020 through September 30, 2021.
The FDA accepts Small Business Certification Requests beginning August 1 prior to next Fiscal Year (which starts on October 1). For example, requests for Fiscal Year 2021 status (which runs from October 1, 2020 through September 30, 2021) will be accepted from August 1, 2020 through September 30, 2021.
A Small Business Certification Request for the next Fiscal Year received before August 1 will not be accepted. Please plan your request strategy accordingly.