This post was written by Paul Sheives and Areta Kupchyk.
FDA announced the medical device user fees for FY 2011, which covers October 1, 2010 – September 20, 2011. The standard fee for a premarket application—or the “base fee”— in FY 2011 will be $236,298. The establishment registration fee for FY 2011 will be $2,179. The FDA has issued a chart listing all of the user fees associated with each type of submission. The FDA also has announced a September 12 public meeting on the reauthorization of the medical device user fee program.