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

摘要

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)).