Project Description

What is FDA registration?

FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products, and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured in the United States. The FDA also inspects and enforces regulations related to these industries.

Organizations that manufacture, re-pack or re-label products in the aforementioned industries must look for FDA registration, with the exception of cosmetics, where registration is voluntary.

The FDA registration process varies depending on the industry but generally involves an annual registration in which organizations are required to list all drugs being manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Inspection results for FDA registered organizations are available on the FDA website.

Is FDA Registration mandatory?

It depends on the type of product. Let’s see some examples below:

Animal and Veterinary

Domestic and foreign establishments that manufacture, repack, or re-label animal drug products in the United States are required to have the FDA Registration. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This process is done in conjunction with the human drug registration process.

Cosmetics

The Voluntary Cosmetic Registration Program (VCRP) is an FDA post-market reporting system for use by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the United States.

Drugs

Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to have the FDA Registration. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products. This information helps the FDA maintain a catalog of all drugs in commercial distribution in the United States.

Food

Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to have the FDA Registration.

Medical Devices

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to have an annual FDA registration. This process is known as establishment registration.

Radiation-Emitting Products

Filing Radiation Safety (Product) Reports for radiation emitting products is required by law. The FDA eSubmitter software replicates several reporting guides and forms. The electronic templates currently available in eSubmitter represent most forms industry is required to have FDA registration.

Tobacco Products

Under section 905 of the Tobacco Control Act, every person who owns or operates any domestic establishments engaged in the manufacture, preparation, compounding, or processing of a regulated tobacco product must have FDA registration for those establishments by December 31 of each year. All registrants must also submit a list of all tobacco products which are being manufactured by that person for commercial distribution, along with certain accompanying information including all labeling.

Vaccines, Blood, Biologics

If you are an establishment that manufactures human cells, tissue, and cellular and tissue-based products (HCT/Ps), FDA regulations require you to have FDA registration and list your HCT/Ps. “Manufacture” includes any or all steps involved in the recovery, processing, storage, labeling, packaging or distribution of HCT/Ps, and the screening or testing of the cell or tissue donor.

FDA regulations require all blood establishments that collect, manufacture, prepare, store under controlled conditions for further distribution or process blood and blood products to register.

Domestic and foreign establishments that manufacture, repack, or re-label drug and biologic products, including vaccines, are required to have the FDA registration. Domestic and foreign drug and biologics manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug and biologic products. This information helps the FDA maintain a catalog of all drugs and biologics in commercial distribution in the United States.

How do I verify FDA approval?

FDA has several databases for the different types of FDA-approved products, which can be consulted online on their website.

Do I need to pay any fees for FDA Registration?

Yes. Depending on the product, FDA charges different fees for FDA Registration.

How to obtain FDA registration?

Passarini Regulatory Affairs has a team of experts trained in a variety of matters related to advice and assistance with the FDA Registration. Our specialists have already conducted several processes with the FDA and are able to provide the best service for your company to market its products in the United States of America.

See below some of the services in our portfolio:

  • Product classification based on FDA criteria;
  • Survey on the existence of a similar product registered to analyze the possibility of preparing a 510K process;
  • Survey of all regulations applicable to the product;
  • Comparative analysis of the product with the similar product already registered;
  • Submission of the process for protocol with the FDA.
  • Product registration with the FDA has no expiration date and will be maintained as long as the company pays the annual product renewal fee.

You may also be interested in:

ANVISA Registration
ANATEL Approval
INMETRO Certification

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