The FDA has issued guidance on FY 2013 medical device user fees for small businesses. The guidance explains how a business may qualify as a “small business” and pay most FY 2013 medical device user fees at substantially discounted rates. While the guidance is substantively the same as the guidance provided for FY 2012, the following new considerations are particularly significant:

  • The guidance explains that there is no small business discount for the establishment registration fee. If this is the only fee a business expects to pay during FY 2013, it should not submit an FY 2013 Small Business Qualification Certification.
  • A foreign business may qualify as a small business, even if it has not submitted a federal (U.S.) income tax return.

As of September 30, this document supersedes “Guidance for Industry, FDA, and Foreign Governments: FY 2012 Medical Device User Fee Small Business Qualification and Certification,” as issued on May 25, 2012.