FDA REGISTRATION SERVICE FEES
There is no reason to pay more for less, because ITB HOLDINGS LLC’s fees are the lowest for FDA Registration of your Facility or Establishment.
Because PPEs (gowns, gloves, face shields, goggles, facemasks and respirators) are Medical Devices, an FDA User Fee of $5,236.00 – $5,546.00 is required for the annual Establishment Registration (Fiscal Year 2020, 2021). Some devices are subject to Premarket Notification 510(k) – Standard Fee: $12,432.00. Small Business Fee: $3,108.00 (Fiscal Year 2021, starting October 1, 2020).
In order to register your establishment and list your hand sanitizer, only our annual fee of $350.00 is needed. Hand sanitizers are OTC Drug Products.
■ No hidden costs
■ No forced options
■ Only what you need or want
■ Reduced fee for multiple services
■ Reduced fee for multiple companies
■ U.S. Agent Service included
■ Same Day Service for extra fee
Click on link below for Biennial Registration Renewal of 2020.
Some registrations require additional Government fees.
You will be informed as expected.