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How does the Medical Device User Fee and Modernization Act (MDUFMA) apply to imports of medical devices?
FDA's 'FY 2009 Medical Device User Fee Small Business Qualification and Certification' guidance is now available. This guidance explains how your business may qualify as a 'small business' and pay most FY 2009 medical device user fees at substantially discounted rates; if you qualify as a small business, you may also qualify to obtain a one-time waiver of the fee for your first (ever) premarket application (premarket approval application, biologics license application, product development protocol, or premarket report).
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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