On Oct. 1, the new 2018 U.S. Food and Drug Administration (FDA) user fees go into effect. Diagnostics manufacturers will notice increased medical device user fees, including a doubling of 510(k) fees and the introduction of a new fee for de novo 510(k) applications. However, small diagnostics companies are eligible for some significant discounts. The FDA Reauthorization Act of 2017 reauthorizes the user fees for five years— through fiscal year 2022. G2 assessed some of the significant features of the reauthorization including the fee increases and the FDA’s new performance goals. Rising User Fees On Aug. 29, the FDA published the fee rates for fiscal year 2018 (effective Oct. 1, 2017). Increases were seen for all registration-related categories. The standard user fee for 510(k) applicants is $10,566; $310,764 for premarket approval (PMA) user fees; and $93,229 for the entirely new de novo classification request user fee For de novo classification requests, the reauthorization sets the new user fee at 30 percent of the PMA user fee set each year, which is significantly more than the a 510(k) premarket notification submission, which will be 3.4 percent of the PMA user fee (and was 2 percent of the PMA user fee in […]