Before you export your medical devices to the United States, register your company with the U.S. Food and Drug Administration, to avoid the detention of your shipment.
Diagnostic tests, ventilators, and personal protective equipment (PPE), including surgical masks, face shields, respirators, gowns, and gloves, are regulated as medical devices.
Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the FDA. However, additional requirements apply.
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.
▪ Premarket Approval (PMA).
▪ Product Development Protocol (PDP).
▪ Humanitarian Use Exemption (HDE).
▪ Biologics License Application (BLA).
All Medical Device Establishments must renew their registration between October 1 and December 31, 2023, regardless of when the initial registration occured.
Before such registration takes place, obtain a DUNS Number issued by Dun & Bradstreet, Inc. Then, a foreign company or registrant must provide the name, address, and phone number of its U.S. Agent such as ITB HOLDINGS LLC.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Registration Number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
When you seek and request the assistance of an FDA Consultant or U.S. Agent, a Service Fee will be due.
- Company Registration
- Product Listing
- U.S. Agent Service
Domestic and foreign companies that are required to register, must pay User Fees to the U.S. Treasury.
Establishment Registration: $6,493.
The establishment registration fee is not eligible for a reduced small business fee.
Premarket Notification 510(k): $4,967. Small Business Fee. Devices exempt from Premarket Notification 510(k) dot not incur this fee.
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.
▪ The FDA does not issue any kind of certificate to demonstrate a manufacturer is in compliance with the agency’s requirements.
▪ Moreover, the FDA does not issue Registration Certificates to medical device establishments.
▪ Also, the U.S. Food and Drug Administration does not certify registration and listing information for firms that have registered.
▪ Finally, registration and Listing do not denote approval or clearance of a firm or their devices.
Nearly 80% of imported surgical masks shipments came from China or South Korea, where FDA Registration Certificates are popular.
Still want or need a certificate? Then, click below:
This database includes:
- medical device manufacturers registered with the FDA
- medical devices listed with the FDA
Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by the FDA.