The FDA is the abbreviation for the U.S. Food and Drug Administration (Food and Drug Administration). For the U.S. Department of Health and Human Services under the jurisdiction of the federal government agencies, its main function is responsible for the U.S. domestic production and import of food, dietary supplements, drugs (including veterinary drugs), medical devices, cosmetics, and radiation electronic products, vaccines, biomedical agents, blood preparations, supervision and management. All products regulated by the FDA must be registered with the FDA before entering the U.S. and obtain a valid registration number before the goods can be successfully cleared at the time of entry. Otherwise, there is a risk that the goods will be detained by the FDA or refused entry. The following are China's largest exports of several categories of products registration requirements: 1. food, beverage & dietary supplements FDA requires that all companies engaged in the production, processing, packaging and storage of food must be exported to the U.S. before the food to the FDA for registration, and to designate an address in the U.S. on behalf of the agent to communicate with the FDA. In addition, the interested party of the shipment is required to submit a Prior Notice to the FDA before the shipment arrives at a U.S. port.2. Medical DevicesThe FDA requires all firms engaged in the manufacture, formulation, dissemination, synthesis, assembly, processing, or import or export of medical devices to register with the FDA before exporting them to the United States.3 The FDA also requires all firms engaged in the manufacture, distribution, synthesis, assembly, processing, or import or export of medical devices to obtain a valid registration number. Obtain a valid registration number. At the time of registration it is also necessary to designate a valid U.S. agent to communicate and liaise with the FDA on its behalf. In addition, the FDA classifies medical device products into the following three categories: Class I - General Surveillance Low Risk (e.g., eyeglasses, band-aids, etc.) Most are exempt from 510(k) Class II - General Surveillance and Special Surveillance Pre-market Notification 510(k) Few are exempt from 510(k) Class III - General Surveillance and Pre-Market Approval (PMA) High Risk (e.g., surgical lasers, PSA experiments, etc.) All types of products are required to be listed with the FDA prior to export to the U.S. in order to obtain a valid MDL number for clearance. 3. Drugs All drugs that are manufactured with the intent to be used for the diagnosis, treatment, symptomatic relief, management, or prevention of disease, have a pharmacological or other direct effect, or are capable of affecting the health, safety, health, or well-being of the population. All drug manufacturing plants that produce drugs intended for the diagnosis, treatment, alleviation, management or prevention of disease that have pharmacological activity or other direct effects, or that affect the function and structure of the body, must be registered with the FDA (drug establishment registration) and have their products listed (drug listing) to obtain a valid NDC number. Non-U.S. companies must also designate a U.S. agent to liaise with the FDA, designate an authorized contact person to communicate with the FDA. 4. Radiation electronic products under the U.S. FD& C Act, Chapter 531 of the requirements of the manufacturer, importer, wholesaler, and distributor of any electronic radiation products are required to submit a report to the FDA. Product reports or abbreviated product reports must be submitted to the U.S. FDA before marketing. Annual reports are due to the FDA on September 1 of each year and are required to cover a 12-month period from the last report end date (June 30th). In addition, non-U.S. companies must designate a U.S. agent to liaise with the FDA. 5. Cosmetics FDA currently implements the principle of voluntary registration of cosmetics, that is, "VCRP" program. The program consists of two parts, one is the registration of cosmetic manufacturers, the other part is the declaration of product ingredients. Companies can choose whether to register (limited to cosmetic manufacturers or packagers) or declare their products. Companies can choose to register with the FDA before or after their products are marketed in the U.S., as cosmetics do not require an FDA registration number for customs clearance. It should be noted that although the FDA implements the principle of voluntary registration for cosmetic products, all cosmetic products that need to be sold on e-commerce platforms such as Amazon and Alibaba need to be registered with the FDA and obtain the appropriate certificate of registration before the platforms can allow them to be listed on the shelves. Although cosmetics do not need to be marketed before the FDA's pre-market review or approval, but the FDA for cosmetic labeling, packaging and other strict requirements, if the product labeling or packaging does not meet the FDA's requirements, then in the U.S. market or after the product or the FDA has the right to detain the product, refused to enter the country or mandatory requirements have been on the shelves of the product off the shelves. For all products regulated by the FDA, in addition to completing the relevant registration, the FDA unified requirements are product labeling must meet the requirements. According to U.S. Customs data, 22% of FDA-regulated products are detained because of unqualified labeling. Therefore, before exporting to the United States, in addition to ensuring that enterprises to complete the relevant registration, but also need to ensure that the product labeling is in line with FDA requirements. Otherwise, even after completing the registration, the product may face the risk of being detained by the FDA, or refused entry.