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.
The full PDF version of this FDA guidance is available here.
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.
For more information on FDA's establishment registration requirements for medical device companies and how to qualify for reduced FDA fees in 2014, please contact:
Peter Quinter, Esq.
Chair, Customs and International Trade Law Group
Shareholder, GrayRobinson, P.A.
1221 Brickell Avenue, Suite 1600
Miami, Florida 33131