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October 16, 2018

Medical Device User Fee Rates

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug and Cosmetic Act (FD&amp;C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019.<br />
Ana Ladino

Ana Ladino

Director, Regulatory Affairs

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