FY 2011 Medical Device User Fee Small Business Qualification and Certification

• Date: January 20, 2011
• Source: www.fda.gov

This guidance explains how your business may qualify as a “small business” and pay most FY 2011 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).

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