The current mailing address for FDA’s Medical Device User Fee Small Business
Certification Request is located at the following web address,
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDev
ice/PremarketSubmissions/ucm577696.htm.
Be sure to include complete, signed copies of all Federal (U.S.) income tax returns and
certifications from foreign national taxing authorities that relate to your Small Business
Certification Request.