15 Sept 2017
Substantial Increase in Registration Fee for Medical Device Facilities
The Food and Drug Administration has increased the fee for medical device facility registrations by 37 percent for fiscal year 2018. Owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the United States, including those that are imported for export only, must register annually with the FDA and pay a fee. For FY 2018, which starts on 1 October, the FDA is increasing this fee from US$3,382 to US$4,624. There are no fee waivers or reductions for small establishments, businesses or groups.
Most establishments required to register must also list the devices they make and the activities performed on those devices at that establishment. If a device requires premarket approval or notification before being marketed in the United States, the owner/operator should also provide the FDA premarket submission number.