Zdrowie i gospodarka · 30/07/2018

FDA Announces Medical Device User Fee Rates for Fiscal Year 2019

The US Food and Drug Administration (FDA) has set the fee rates for medical device user fees for fiscal year 2019, which apply from October 1, 2018, through September 30, 2019. These fees are part of the Medical Device User Fee Amendments of 2017 (MDUFA IV) and are used to support the review of medical device submissions and annual reports.