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Medical Devices
MEDICAL DEVICE 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.

MEDICAL DEVICE ESTABLISHMENT REGISTRATION

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.

The marketing pathways include: Premarket Notification (510(k), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol (PDP), Humanitarian Use Exemption (HDE), and Biologics License Application (BLA).

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.

Government Fees

All establishments that are required to register must pay an annual registration user fee.

$5,236.00 | Establishment Registration, (FY 2020 – October 1, 2019 through September 30, 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).

Reduced Medical Device User Fees: Small Business Determination (SBD) Program
A business that is qualified and certified as a “small business” is eligible for a substantial reduction in most of user fees. A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.
How to submit a Small Business Certification Request? Contact ITB HOLDINGS LLC for additional information.

Devices exempt from Premarket Notification 510(k) dot not incur this fee.

Personal Protective Equipment (PPE)

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.

Annual Registration Renewal

All Medical Device Establishments must renew their registration between October 1 and December 31, 2020.

FDA Compliance

The FDA does not issue any kind of certificate to demonstrate a manufacturer is in compliance with the agency’s requirements.

FDA does not issue Registration Certificates to medical device establishments. FDA does not certify registration and listing information for firms that have registered. Registration and Listing do not denote approval or clearance of a firm or their devices.

Nearly 80% of imported surgical masks shipments come from China or South Korea, where FDA Registration Certificates are popular.