• FDA Publishes 2014 Medical Device Fees for Small Businesses
  • August 15, 2013 | Author: Peter A. Quinter
  • Law Firm: GrayRobinson, P.A. - Miami Office
  • On August 2, 2013, U.S. Food and Drug Administration (FDA) published Guidance for Industry and Food and Drug Administration Staff and Foreign Governments: FY 2014 Medical Device User Fee Small Business Qualification and Certification.

    The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for most types of medical device applications. A business that is qualified and certified as a “small business” is eligible for a substantial reduction in most of these user fees. This guidance describes the process for how a business may request qualification and certification as a small business. A business that qualifies as a “small business” is eligible for a significant reduction in the fees.

    FDA's medical device fees increase to $3,313 at the start of the FDA's 2014 fiscal year. No small business reductions are available for this particular fee.