FDA registration support for food, cosmetics, drugs and devices

What our FDA registration support includes

The US Food and Drug Administration requires many facilities that make, process, pack or hold products for the US market to register with it, and in many cases to list their products. Which registration applies, how often it must be renewed and whether a fee is due depend on the type of product.

Food facilities register through the FDA Industry Systems and must renew every two years between 1 October and 31 December of even-numbered years. Medical device establishments register and list their devices each year and pay an annual establishment fee. Drug establishments register and list their products through electronic submissions and renew each year. Under the Modernization of Cosmetics Regulation Act, cosmetic facilities register and responsible persons list their products.

Our service takes you through the right route for your products, collects and checks the information, completes the submission with you and sets up reminders for renewals.

• Product review to confirm which FDA registration and listing apply
• Collection of facility, owner, product and contact information
• Unique facility identifier and account set-up support where needed
• Completion of the registration or listing submission with you
• US agent arrangements for foreign facilities through our partners
• Renewal reminders and updates when details change

Contract manufacturers, packers and warehouses are often in scope as well. If your product is made or held at another company's facility, that facility may need its own registration, and we help you check this across your supply chain.

Food, cosmetics, drugs and devices compared

Food and beverage facilities, including dietary supplements and animal food, use food facility registration. It is free of charge, and foreign facilities must name a US agent. Registration also connects to other duties, such as prior notice for imported food shipments and the preventive controls and foreign supplier verification rules.

Cosmetic facilities and products follow the newer rules introduced by the Modernization of Cosmetics Regulation Act, with facility registration, product listing, adverse event reporting and safety substantiation responsibilities for the responsible person.

Medical devices need establishment registration and device listing, an annual fee and, for many devices, a premarket submission such as a 510(k) before sale. Drugs need establishment registration and drug listing, and most also need approval or must follow an over-the-counter monograph. Registration alone never replaces these market authorizations.

If you are not sure which group your product falls into, for example a product that is both a cosmetic and a drug, we start with that question, because it changes everything after it.

Labelling is closely linked. Product names, ingredient statements, nutrition or drug facts panels and device labels must follow US rules, and registration details should match them. We point out obvious inconsistencies during our review, although a full labelling review is a separate piece of work.

What decides the price

FDA registration support with EUROTECH starts at $1,000. The price depends on the route and the amount of information to prepare.

• Product type: food, cosmetic, drug or device
• Number of facilities to register
• Number of products to list
• US agent service needed for foreign facilities
• Renewal support over more than one cycle

FDA user fees, where they apply, such as the medical device establishment fee, are paid to the FDA and listed separately in your written quote.

Companies with many products, such as a cosmetics brand with large ranges or a device maker with many models, need more preparation time for listing, which is reflected in the quote.