How will FDA show that medical device review performance is improving?
The performance goals that FDA will pursue as part of the user fee program include specific year-by-year goals for improvement in device review times, as well as other important goals, such as maintaining performance in areas where specific goals have not been identified, using fee revenues for reviewer training and expanded use of outside consultants and contractors, modular reviews, and improving the timeliness of premarket inspections. The law provides for annual reports by FDA and studies by GAO.
