Companies (establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States, are required to register and list their products with the U.S. Food and Drug Administration, then renew their registration between October 1 and December 31, each year.
ITB HOLDINGS LLC provides the following services to domestic and foreign companies that are manufacturers, exporters, importers, or distributors:
■ Medical Device Establishment Registration
■ Medical Device Listing
■ U.S. Agent Service (Foreign Companies)
■ Premarket Notification 510(k)
Once your company becomes a client, we help you setup and pay FDA’s User Fees.
All establishments that are required to register must pay an annual registration user fee.
$5,236.00 | Establishment Registration, (FY 2020)
The establishment registration fee is not eligible for a reduced small business fee.
$2,899.00 | Premarket Notification 510(k), single payment
Small Business Fee | (FY 2020 – October 1, 2019 through September 30, 2020).
Devices exempt from Premarket Notification 510(k) dot not incur this fee.
Diagnostic tests, ventilators, and personal protective equipment (PPE) — including surgical masks, face shields, respirators, gowns, and gloves, are regulated as medical devices.
Therefore, contact ITB HOLDINGS LLC before exporting or importing these products.
Class I and Class II Devices Exempt from Premarket Notification 510 (k)