FDA officially released the charging standard for medical devices in fiscal year 2016

Source: FDA official website August 12, 2015, the US FDA officially released the evaluation fee and annual user fee standard for different application ways of medical devices in fiscal year 2016 on August 3, which is shown in the following table: charging items 2015 (unit: USD) 2016 (unit: USD) Factory registration fee (i.e annual user fee) 3646 3845 510 (k) review fee 5018 5228 513 (g) application fee for classification and definition 3387 3529 pre market approval review fee (PMA, BLA, PDP) 250895 261388 annual report fee for class III devices 8781 9149 compared with the charging standard in 2015, 2016 The annual user fee and review fee of each year increased by about 4%, roughly the same as the increase of previous years FDA has preferential policies for small enterprises to review fees If the company's annual turnover is less than US $100000000, it can apply for this offer as a small business If small enterprises apply for registration through 510 (k), the review fee can be reduced by 50%; if they apply for registration through PMA, the review fee in 2016 will be US $65347, only about a quarter of the general PMA review fee, which is one of the specific manifestations of FDA's encouragement of small and medium-sized enterprises to innovate medical devices.