regulatory and quality system professionals | 919.313.3960
FDA Announces FY 2018 MDUFA Fees

FDA Announces FY 2018 MDUFA Fees

MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees for certain medical device applications, submissions, reporting on class III devices and fees for establishments subject to registration. These fees are in effect from October 1, 2017 through September 30, 2018. 2018 MDUFA Fees FDA user fees have increased across all categories. This increase will substantially impact larger companies. Most FDA user fees increased 33%; however the standard application fee for a 510(k) submission rose 125% to $10,566. The increase in fees is a result of inflation adjustment plus any additional increase FDA feels is necessary to reach the inflation adjusted total revenue amount the agency has identified for the year. Application Type 2018 Standard Fees 2018 Small Business Fees 510(k) premarket notification submission $10,566 (+125%) $2,642 (+13%) 513(g) request for classification information $4,195 (+33%) $2,098 (+33%) Premarket application (PMA) $310,764 (+33%) $77, 691 (+33%) De novo classification request $93,229 (new) $23,307 (new) Annual fee for periodic reporting on a class III device $10,877 (+33%) $2,719 (+33%) Annual establishment registration $4,624 (+37%) $4,624 (+37%) Qualifying for Small Business User Fees At the same time that the FDA announced their 2018 fees, they also updated their guidance FY 2018 Medical Device User Fee Small Business Qualification and Certification. A business that is qualified as a “small business” is eligible for reduced user fees. A small...