Medical Device Establishment Registration
Fee: $399 USD / Per Year
FDA Cost For FY 2022 $5,672 USD / Per Year
Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. This process is known as establishment registration.
Congress has authorized FDA to collect an annual establishment registration fee for device establishments. The establishment registration fee is not eligible for a reduced small business fee.
The annual registration user fee for fiscal year 2022 follows:
To have “FDA Registration Assistance” assist with your companies Medical Device Establishment Registration please CONTACT US.