Enacted by the Medical Device User Fee Amendments to the Federal Food, Drug, and Cosmetic Act, the FDA collects user fees for certain medical device submissions as well as annual fees for certain reports. Such fees are used for certain medical device application reviews and reports.
A report from the Regulatory Affairs Professionals Society lays the FY 2015 fees next to the previous two years’ fees to illustrate the slight decrease in fees. For example, premarket application user fees will be $250,895 for FY 2015 compared to $258,520 for FY 2014.
Qualified applications, generally first-time filers and small businesses, can receive fee waivers or lowered fees.
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