The following domestic and foreign companies must renew their registration before December 31, 2024, regardless of when the initial registration was completed:
▪ OTC Drug Establishment.
▪ Prescription Drug Establishment.
▪ Medical Devices Establishment.
Please make sure to obtain a DUNS Number, which is required.
Unless exempt, all domestic and foreign facilities or establishments manufacturing, holding, exporting, importing and distributing FDA regulated products, are required to register with the U.S. Food and Drug Administration, and renew related registrations:
▪ Food Facility.
▪ Dietary Supplements Facility.
▪ Food Canning Establishment.
▪ Drug Establishment.
▪ OTC Drug Establishment.
▪ Medical Device Establishment.
▪ OTC Cosmetic Establishment.
You may want to take this opportunity to switch U.S. Agent, if your company is in Canada, Mexico, Brazil, Australia, India, Pakistan, Russia, China, South Korea, Japan, Portugal, Spain, Italy, France, Belgium, Netherlands, Switzerland, Germany, Sweden, United Kingdom, Ireland, and many other countries.
And as always, ITB HOLDINGS LLC makes the process easy, even for clients who speak only foreign languages.
When you seek and request the assistance of FDA Consultants or U.S. Agents such as ITB HOLDINGS LLC, expect to pay Service Fees.
MORE PAYMENT OPTIONS
The United States spends $3.3 trillion per year on healthcare, which is more than the combined expenditures of China, Japan, Germany, India, United Kingdom, Italy, Brazil, Canada, Russia, South Korea, Spain, Australia, Mexico, Indonesia, the Netherlands, Saudi Arabia, Turkey and Switzerland ($3.24 trillion).
Therefore, exporting your personal protective equipment (PPE) or other medical devices, as well as over-the-counter (OTC) drug products to its market, makes sense.
However, you must first register your establishment with the U.S. Food and Drug Administration, and list your products.
Futhermore, all the following registrations are preceded by the payment of User Fees to the U.S. Treasury. You must first have an account.
Medical Devices Establishment Registration: $7,653.
Monograph Drug Facility (MDF) Facility Fee: $26,153.
Contract Manufacturing Organization (CMO) Facility Fee: $17,435.
Other User Fees may apply.
REGISTRATION
- Alcohol Hand Sanitizers
- Alcohol Wipes
- Sunscreens
- Skin Protectant Drug Products
- Nighttime Sleep Aid Drug Products
- Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products.
REGISTRATION
- Facemasks
- Surgical Masks
- N95 Respirators
- Gowns, Face Shields, Gloves, Goggles
- All other medical devices
Are you or will you be offering Food Facility Registration Services to local corporations?
Then, our discounts for multiple registrations can help you achieve your business goals. And, your own clients will appreciate the additional savings.
FDA REGISTRATION
SERVICE FEE?