The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval.  The National Law Review reports that the new fees reflect an increase of greater than 4%.

The new fees will apply from October 1, 2015, through September 30, 2016.  Some of the standard user fees for FY 2016, which are listed in the FDA notice as percentages of a full premarket application fee, are reportedly as follows:

  • Pre-Market Application (PMA): $261,388
  • Panel-track supplement: $196,041
  • 180-day supplement: $39,208
  • Real-time supplement: $18,297
  • 510(k) premarket notification submission: $5,228
  • 30-day notice: $4,182
  • 513(g) request for classification information: $3,529
  • Annual fee for periodic reporting on a class III device: $9,149
  • Annual establishment registration fee: $3,845

Small businesses may pay reduced fees if they qualify before making their submission to the FDA.  To qualify, businesses must file a FY 2016 Small Business Qualification and Certification request (as well as several other documents, including tax records).   The establishment registration fee is not subject to reduction for small businesses; consequently, if that is the only fee a business anticipates paying in FY 2016, a Small Business Qualification and Certification request is unnecessary.

The FDA notice includes information on how the fees for FY 2016 were determined, the payment procedures that should be followed, and details regarding how businesses may qualify for reduced small business fees.