CDRH Industry: FY 2015 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, FDA Staff, and Foreign Governments

A guidance document titled, "FY 2015 Medical Device User Fee Small Business Qualification and Certification" has recently been posted.  The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for most types of medical device applications. A business that is qualified and certified as a “small business” is eligible for a substantial reduction in most of these user fees. This guidance describes the process for how a business may request qualification and certification as a small business.  For more information, please see: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM407325.pdf