FDA Unveils Spike in MDUFA Fees Effective Oct. 1

The FDA released revised user fee rates for fiscal 2018 — including some significant increases and a new fee for de novo classifications.

The standard fee for a premarket application is increasing from $234,495 to $310,764. Registration fees, which must be paid in full prior to submitting any review requests, are increasing from $3,382 to $4,624.

Domestic and foreign medical device establishments must pay the registration fee, with the exception of small businesses, as defined by the agency in a separate guidance. To qualify as a small business, an establishment’s gross sales must not have exceeded $100 million during the most recent tax year, including sales by affiliates. Requests for “small business” status must be submitted before Sept. 30, 2017.

A panel-track supplement fee is increasing from $175, 871 to $233, 073, a 180-day supplement fee will increase to $46, 615, up from $35, 174 for FY2017, and the newly established de novo classification fee will be $93,229.