Guidance for Industry, Food and Drug Administration, and Foreign Governments; Fiscal Year 2008 Medical Device User Fee Small Business Qualification and Certification; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "FY 2008 Medical Device User Fee Small Business Qualification and Certification." This guidance explains how a business headquartered in the United States or headquartered in a foreign nation may respectively qualify as "small business" under the medical device user fee provisions of the Federal Food, Drug, and Cosmetic Act (the act). A "small business" may pay certain medical device user fees at a substantial discount from the standard (full) fee rates and may obtain a one-time fee waiver for its first premarket application (a premarket approval application (PMA), biologics license application (BLA), product development protocol (PDP), or premarket report (PMR)).