Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program?utm_medium=email&utm_source=govdelivery FY 2026 Small Business Applications Close August 1 — FY 2027 Applications Open Immediately After If you are interested in applying to the MDUFA Small Business Determination Program, please read this important update about upcoming application deadlines. FY 2026 Deadline: August 1, 2026, at 4:00 PM ET The deadline to submit a FY 2026 MDUFA Small Business Request is 4:00 PM ET on August 1, 2026. FY 2026 determinations are effective from October 1, 2025, through September 30, 2026. Applications submitted after 4:00 PM ET on August 1, 2026, will not be accepted for FY 2026. If you plan to submit a medical device application during FY 2026 and are seeking a reduced fee or waiver, you must have your small business determination before you submit your device application. Do not submit your device application until you have received your small business determination from FDA. FY 2027 Applications Open: August 1, 2026, at 4:01 PM ET The application window for FY 2027 MDUFA Small Business Requests opens at 4:01 PM ET on August 1, 2026. FY 2027 covers October 1, 2026, through September 30, 2027. Applications submitted before 4:01 PM ET on August 1, 2026, will not be accepted for FY 2027. How to Apply All Small Business Requests must be submitted electronically through the CDRH Portal. Step-by-step instructions are available on the Reduced Medical Device User Fees: Small Business Determination (SBD) Program page. As stated in FDA's guidance, Medical Device User Fee Small Business Qualification and Determination (issued July 31, 2025), FDA accepts Small Business Requests for a given fiscal year beginning August 1 of the prior year. Requests for the next fiscal year received before August 1 will not be accepted. Medical Device User Fee Small Business Qualification and Determination Guidance for Industry, Food and Drug Administration Staff and Foreign Governments July 2025 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-user-fee-small-business-qualification-and-determination?utm_medium=email&utm_source=govdelivery