Medical Device Establishment Registration

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:

Year FY 2022
Fee $5,672

To have “FDA Registration Assistance” assist with your companies Medical Device Establishment Registration please CONTACT US.

Source: FDA

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