On July 30, 2026, the U.S. Food and Drug Administration (FDA) issued a Federal Register notice announcing medical device user fees and annual establishment registration fees for Fiscal Year 2027 (FY 2027), effective October 1, 2026, through September 30, 2027.
All medical device manufacturers, importers, and distributors must pay an annual establishment registration fee to FDA. The establishment registration user fee for FY 2027 is $13,785. All the medical device registration renewals must be paid between October 1, 2026, and December 31, 2026. If the user fee is paid prior to October 1, 2026, FDA will apply it to the FY 2026, not FY 2027.
For FY 2027, the FDA may grant a waiver of the annual establishment registration fee (excluding the initial registration) to certain small businesses certified through the Small Business Determination (SBD) Program who demonstrate that paying the fee would represent a financial hardship as determined by the FDA. For more information, see the section Small Businesses here.
Manufacturers, importers, and distributors failing to pay the relevant fees risk being detained at the border. Don’t let that happen to you. FDAImports can help you navigate this process and ensure you are registered correctly and on time.
FDAImports can also ensure that all FDA requirements are satisfied, including 510(k) preparation and submission, medical device labeling, medical device quality system requirements, and complaint handling systems. FDA is adding more and more foreign medical device companies to Import Alerts 89-04, 89-08 and 80-04.
