Ana Ladino

Director, Regulatory Affairs

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&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.

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Section 738 of the FD&C Act (21 U.S.C. 379j) establishes fees for certain medical device applications, submissions, supplements, notices, and requests, for periodic reporting on class III devices; and for the registration of certain establishments. Under statutorily defined conditions, a qualified applicant may receive a fee waiver or may pay a lower small business fee.

The FDA medical device user fees will increase by about four percent for the agency’s 2019 fiscal year. The latest FDA user fee increases are much less substantial than those put in place last year. The FY 2019 revenue from adjusted fee is projected to be $207,708,611.

The medical device user fee rates for the fiscal year 2018 were significantly increased by 33% or more (under the Medical Device User Fee Amendments of 2017 (MDUFA IV)). The standard fee for 510(k) premarket notification submissions increased around 125% (from $4,690 to $10,566). The FDA created the De Novo applications fee for the first-time last year.

Read more about this update in our whitepaper.