Medical Devices
ESTABLISHMENT REGISTRATION

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.

MEDICAL DEVICE ESTABLISHMENT REGISTRATION

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.

Government 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.

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.

 

Class I and Class II Devices Exempt from Premarket Notification 510 (k)

PART 862 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
PART 864 HEMATOLOGY AND PATHOLOGY DEVICES
PART 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES
PART 868 ANESTHESIOLOGY DEVICES
PART 870 CARDIOVASCULAR DEVICES
PART 872 DENTAL DEVICES
PART 874 EAR, NOSE, AND THROAT DEVICES
PART 876 GASTROENTEROLOGY-UROLOGY DEVICES
PART 878 GENERAL AND PLASTIC SURGERY DEVICES
PART 880 GENERAL HOSPITAL AND PERSONAL USE DEVICES
PART 882 NEUROLOGICAL DEVICES
PART 884 OBSTETRICAL AND GYNECOLOGICAL DEVICES
PART 886 OPHTHALMIC DEVICES
PART 888 ORTHOPEDIC DEVICES
PART 890 PHYSICAL MEDICINE DEVICES
PART 892 RADIOLOGY DEVICES