Medical Devices: Guidance for Industry and FDA: Fiscal Year 2003 Medical Device User Fee and Modernization Act of 2002 Small Business Qualification Worksheet and Certification; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "FY 2003 MDUFMA Small Business Qualification Worksheet and Certification." This guidance explains how you can certify that you qualify as a "small business" within the meaning of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and provides a copy of, and instructions for, Form FDA 3602, "FY 2003 MDUFMA Small Business Qualification Certification." If FDA decides that you are a small business, you will be eligible for reduced or waived small business fees for medical device applications that you submit from October 1, 2002, through September 30, 2003.