FDA Registration for Exporters to the United States

The FDA (U.S. Food and Drug Administration) is the federal agency that regulates food, drugs, biological products, medical devices, radiation-emitting products, cosmetics, veterinary products and tobacco products in the United States. A company that wants to export these products to the US has to meet the FDA requirements for its product category before shipment.

For FDA registration and the related steps, apply to CE Danışmanı (CE Consultant); we manage the whole process for you.

Registration, listing, clearance and approval are different things

People often ask for an “FDA certificate”. The FDA does not issue a general certificate for products or companies. What applies depends on the product:

What the FDA approves and what it does not

• Companies and facilities: the FDA does not approve companies, facilities or laboratories. Owners register their facilities, and the FDA may inspect them.
• New drugs and biological products: approved before marketing.
• Compounded drugs: not approved by the FDA.
• Medical devices: a risk-based system with Class I, II and III. Class III devices generally need premarket approval. Most Class II devices need 510(k) clearance. Most Class I devices are exempt from premarket review.
• Human cells and tissues: regulated with a risk-based approach.
• Food: food products do not need premarket approval, but food additives must be approved before they are used in food.
• Cosmetics: cosmetic products and their ingredients are not approved before marketing, with the exception of colour additives.
• Tobacco products: the FDA regulates them, but that is not an approval of their safety.

Food facility registration

Under the Bioterrorism Act, domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must register with the FDA. Food from a foreign facility that is not registered can be held at the port of entry and refused.

The registration includes:

• Name, address and telephone number of the facility, and its trade names
• A statement that the information submitted is true and accurate
• For foreign facilities, the name, address and telephone number of a US agent
• An emergency contact telephone number

Farms, retail food establishments, restaurants, non-profit food establishments, fishing vessels and facilities regulated exclusively by the US Department of Agriculture (meat, poultry and egg products) are among those that do not have to register.

Typical steps

1. Identify the product category and the FDA requirements that apply to it.
2. Review the formulation or the product specification against the FDA rules.
3. Obtain a DUNS number for the manufacturer, and for the US agent or distributor if they do not have one.
4. Appoint the US agent.
5. Prepare the label in line with the FDA labelling rules for the category.
6. Complete the registration, and the listing or premarket submission where the product needs one.

How long this takes depends on the category. A facility registration is quick; a premarket submission for a device or an approval for a drug takes much longer.

Controls at import

The FDA can examine products offered for import and take samples. The controls are:

• Label examination: whether the labelling meets the requirements for the product category.
• Field examination and sampling: a physical check of the product, for example whether it matches the documents, how it was stored, and whether it contains additives that are not permitted. The decision is based on the risk of the product, earlier violations of the product or the company, or routine surveillance.

Using the FDA name and logo

The FDA logo may not be used on product labels or in marketing, even for an approved product. Unauthorised use is a violation of federal law and can lead to civil or criminal penalties. A registered facility or a listed product may not be described as “FDA approved”.

Recalls

When a product on the market presents a health risk, it can be recalled. The FDA assesses the hazard, classifies the recall and publishes it on its website under recalls, market withdrawals and safety alerts.

FDA, CE and EAC

FDA requirements are for the United States. CE marking is for the European Union and Turkey, and EAC is for the Eurasian Economic Union. The procedures differ, so one does not replace another. A medical device sold in Turkey also needs ÜTS registration.

How CE Danışmanı helps

• Identifying which FDA requirements apply to your product
• Collecting and preparing the documents, and translating them
• Coordinating with the US agent
• Reviewing the label against the FDA rules