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.
PPEs (gowns, gloves, face shields, goggles, facemasks and respirators) are Medical Devices. Therefore, an FDA User Fee of $5,546.00 is required for the annual Establishment Registration (Fiscal Year 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).
https://www.itbhdg.com/fda-fees/
info@itbhdg.com
T: +1 855-389-7344
T: +1 855-510-2240
T: +44 800-610-1577
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