ESTABLISHMENT
Before you export your medical device to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.
A Medical Device regulated by the FDA under the Federal Food Drug & Cosmetic (FD&C) Act is defined as
■ an “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
■ recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
■ intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.
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)
Most Medical Device Establishment Registrations are completed within 14 days after your payment is received, when a Premarket Notification 510(k) is not required and requested.
All establishments that are required to register must pay an annual registration user fee.
$5,546.00 | Establishment Registration, (FY 2021)
The establishment registration fee is not eligible for a reduced small business fee.
$3,108.00 | Premarket Notification 510(k), single payment
Small Business Fee | (FY 2021).
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.
All Medical Device Establishments must renew their registration between October 1 and December 31, 2021.