Registration & Listing
Many companies must be registered with FDA before they sell their products in the U.S. Some
products must also be "listed" with FDA before they are sold in the U.S. It used to be simple
to register your facility and list your products, amounting to filling out some simple forms. Now
you have to use an electronic registration and listing system that requires you to become
validated as a user and to learn special software, nomenclature, and rules in order to submit
data electronically directly to FDA.
Many companies that have been registered with FDA in the past find they cannot navigate the
new FDA registration and listing processes. FDAImports.com, LLC performs these services
regularly for its foreign and domestic drug manufacturers and distributors and medical device
manufacturers, distributors, importers and foreign exporters. In addition, FDAImports.com, LLC
performs registration services for food establishments. FDAImports.com, LLC acts as U.S.
Agent for many foreign food, drug and medical device manufacturers.
Free FDA Registrations? For Most Products, You Betcha
FDAImports.com, LLC submits registrations for food, drug, medical device, cosmetic, tobacco, and dietary supplement facilities. Most facility registrations are processed at no charge by FDAImports.com LLC (drug and device establishments are subject to a remarkably low fee). We have years of experience dealing with the FDA systems for registration. Once we have all the proper information, we can normally process a registration within three business days.
Additionally, FDAImports.com, LLC frequently helps its clients file their official product listings, which are required for drugs, medical devices, tobacco products, and dietary supplements. These listings can be complex and time-consuming, but we are here to help. Let us take the burden of navigating FDA’s complex online systems for you.
Those firms located outside the United States who wish to register with FDA must designate a US Agent. FDA uses the US Agent to facilitate communications with the foreign firm. FDAImports.com is willing to serve as your company’s US Agent.
For more information about our registration and listing services fee schedule, click here.
Contact us now for assistance with FDA registration, listing, or U.S. Agent services.