The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by regulating imported products. Any company that plans to distribute food, animal, medical, or beauty products for the U.S. market is required to register with FDA.
Register Today
FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API, medical devices, or cosmetic products in the USA. Companies that manufacture, process, pack, or store these products in the United States may be required to register with the FDA. Here are some examples of the types of companies that require FDA registration:
- Food manufacturers, processors, and packers
- Drug manufacturers, packers, and repackers
- Medical device manufacturers and importers
- Cosmetics manufacturers and processors
It's important to note that the FDA has specific registration requirements for each type of product, and the registration requirements for all kinds of companies are not the same.
Having a U.S. Agent is a requirement of the FDA, for all companies that do not have a place of business within the United States. If you are a foreign based manufacturer, you will not be able to register your facility, list your products and even submit your FDA marketing authorization applications unless you designate a U.S. Agent.
Identification of and contact information for a U.S. agent is required for all foreign manufacturers when they register and list with FDA.
All Drug, API, and Medical Device establishments registered with FDA must renew their registration annually between October 1st and December 31st. Food facilities must renew their FDA registration between October 1st and December 31st of every even-numbered year (once every 2 years). The FDA may consider the products of companies that do not comply with FDA renewal requirements as misbranded and may lead to FDA detention of your products.
The annual establishment registration renewal and drug listing certification period is now open and will close on December 31, 2023. This does not apply to private label distributors. You may submit a Blanket No Changes Certification of Product Listing if you are acting as an authorized agent for the registered establishment.
FDA Titan Consultants, Inc. works closely with all levels of business. Helping small companies and manufacturers, as well as large corporations to achieve U.S. FDA compliance. Certificates of Registration* will be supplied by FDA Titan Consultants, demonstrating your company has met the U.S. FDA registration requirements, and FDA Titan Consultants will provide confirmation of the successful completion of the United States Food and Drug Administration’s registration requirements.**
FDA Titan Consultants, has been working with, and helping companies to successfully register, and comply, with U.S. Food and Drug Administration (FDA) regulations for over 25 years.
*Please note Certificates of Registration are not required by the U.S. FDA: the Agency does not issue or recognize Certificates of Registration.
*FDA Titan Consultants, Inc. is not affiliated with the U.S. Food and Drug Administration.
FDA registration is the basic requirement for domestic and foreign establishments that manufacture or market food, drug, API, medical devices, or cosmetic products in the USA. Companies that manufacture, process, pack, or store these products in the United States may be required to register with the FDA. Here are some examples of the types of companies that require FDA registration:
- Food manufacturers, processors, and packers
- Drug manufacturers, packers, and repackers
- Medical device manufacturers and importers
- Cosmetics manufacturers and processors
It's important to note that the FDA has specific registration requirements for each type of product, and the registration requirements for all kinds of companies are not the same.
Having a U.S. Agent is a requirement of the FDA, for all companies that do not have a place of business within the United States. If you are a foreign based manufacturer, you will not be able to register your facility, list your products and even submit your FDA marketing authorization applications unless you designate a U.S. Agent.
Identification of and contact information for a U.S. agent is required for all foreign manufacturers when they register and list with FDA.
All Drug, API, and Medical Device establishments registered with FDA must renew their registration annually between October 1st and December 31st. Food facilities must renew their FDA registration between October 1st and December 31st of every even-numbered year (once every 2 years). The FDA may consider the products of companies that do not comply with FDA renewal requirements as misbranded and may lead to FDA detention of your products.
The annual establishment registration renewal and drug listing certification period is now open and will close on December 31, 2023. This does not apply to private label distributors. You may submit a Blanket No Changes Certification of Product Listing if you are acting as an authorized agent for the registered establishment.
FDA Titan Consultants, Inc. works closely with all levels of business. Helping small companies and manufacturers, as well as large corporations to achieve U.S. FDA compliance. Certificates of Registration* will be supplied by FDA Titan Consultants, demonstrating your company has met the U.S. FDA registration requirements, and FDA Titan Consultants will provide confirmation of the successful completion of the United States Food and Drug Administration’s registration requirements.**
FDA Titan Consultants, has been working with, and helping companies to successfully register, and comply, with U.S. Food and Drug Administration (FDA) regulations for over 25 years.
*Please note Certificates of Registration are not required by the U.S. FDA: the Agency does not issue or recognize Certificates of Registration.
*FDA Titan Consultants, Inc. is not affiliated with the U.S. Food and Drug Administration.