FDA Announces Medical Device User Fees for FY 2011, Upcoming Meeting (Sept. 12)
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.
