The U.S. Food and Drug Administration (FDA) is a law enforcement agency of the U.S. federal government and is part of the U.S. Department of Health and Human Services (HHS), whose primary responsibility is to protect and promote public health by regulating and overseeing food and drug products. By regulating and supervising food, drugs, medical devices, cosmetics, animal drugs and tobacco products, FDA filing is not only a legal requirement, but also an important measure to protect product safety, enhance market competitiveness, strengthen brand reputation, facilitate cross-border trade and promote business improvement. Through FDA filing, enterprises can legally enter the U.S. market and gain the trust of consumers and the market, thus realizing sustainable development and long-term benefits.
FDA Food Category
Under the Food Safety Modernization Act (FSMA), all companies exporting food to the United States must register with the FDA. This is an important legal measure to ensure the safety of imported food. Food products that are not registered with the FDA may be refused importation, and registration is one of the necessary requirements for products to enter the U.S. market.
Compliance: Any business or individual involved in the production, processing, packaging, importing, wholesaling, retailing, and food service of food products in the United States is required to comply with the FDA's food compliance requirements.
Documents required for filing: Application form, Dun & Bradstreet number, U.S. authorized agent.
Common products are processed foods, beverages, baked goods, dairy products, processed meats (e.g. sausages, bacon), frozen meats, ready-to-eat meat products, etc., fish, shellfish, and processed seafood products (e.g. canned tuna, frozen shrimp). All types of fresh fruits and vegetables, including organic and non-organic products, dried fruits and nuts, all kinds of cooking seasonings, spices, sugar, salt, oil, etc., preservatives, colorants, flavor enhancers, stabilizers, etc., dietary supplements, all kinds of pet food and snacks, which also need to comply with FDA regulations.
FDA Cosmetics Category
Under the Federal Food, Drug, and Cosmetic Act, all cosmetics sold in the U.S. market must comply with FDA regulations, including requirements for ingredients, safety, labeling, and packaging. Cosmetics that are not FDA-compliant may be considered illegal and may be detained or refused by U.S. Customs, and companies may face fines and legal liability.All businesses and individuals involved in the manufacture, packaging, importation, distribution, retailing, research and development, advertising and marketing of cosmetics are required to comply with the FDA's cosmetic compliance requirements. These requirements include safety of ingredients, accuracy of product labeling, safety of packaging materials, and sanitation standards for manufacturing facilities. Compliance with these regulations is not only a legal obligation, but also a necessary measure to protect consumer safety, enhance product competitiveness in the marketplace, and enhance corporate reputation.
Documents required for filing: application form, Dun & Bradstreet number, U.S. Authorized Agent, physical drawing of the product, and product package drawing.Docket Time: 7-14 days
Common products are face care products, body care products, sun care products, beauty and make-up products, nail care products, hair care products, styling products, hair coloring products, oral care products, perfume and aromatherapy products, men's care products, men's skincare products, baby and child care products, baby and child skincare products, baby and child cleansing products, other personal care products, and foot care products.
FDA Over-the-Counter Labeling Category
Under the Federal Food, Drug, and Cosmetic Act, all OTC products sold in the U.S. market must comply with FDA regulations, including requirements for ingredients, safety, labeling, and packaging. OTC products that are not FDA-compliant are considered illegal and may be detained or refused by U.S. Customs, and companies may face fines and legal liability. All companies and individuals involved in the manufacture, packaging, importation, distribution, retailing, research and development, advertising and marketing of OTC drugs are required to comply with the FDA's OTC drug compliance requirements. Compliance with these regulations is not only a legal obligation, but also a necessary measure to protect consumer safety, enhance product competitiveness in the marketplace, and enhance corporate reputation.
Documents required for filing: Application form, Dun & Bradstreet number, U.S. Authorized Agent
Docket Time: 14-20 days
Common products are cold and cough remedies, pain relievers, anti-allergy medications, digestive medications, skin care medications, eye care medications, oral care medications, gynecological care medications, other common over-the-counter medications, vitamin and mineral supplements, various vitamin tablets, mineral supplements, smoking cessation products, sleep aids, and more.
FDA Class I Medical Devices
Under the Federal Food, Drug, and Cosmetic Act, all medical devices sold in the U.S. market must comply with FDA regulations, including design, manufacturing, packaging, labeling, and marketing requirements. Medical devices that are not FDA-compliant are considered illegal and may be detained by U.S. Customs or refused importation, and companies may face fines and legal liability.
All companies and individuals involved in the design, manufacture, assembly, packaging, importation, distribution, retailing, research and development, advertising and marketing of medical devices are required to comply with FDA's medical device compliance requirements. Compliance with these regulations is not only a legal obligation, but also a necessary measure to protect consumer and patient safety and to enhance the competitiveness of products in the marketplace and the reputation of the organization.
Documents required for filing: Application form, Dun & Bradstreet number, U.S. Authorized Agent
Docket Time: 7-14 days
Common products are medical thermometers, medical blood pressure monitors, stethoscopes, etc., disinfection and sterilization equipment, medical gloves, disinfectants, sterilization packaging materials, etc., non-invasive diagnostic equipment, examination gloves, examination lamps, mouth mirrors, etc., test tube holders, measuring cylinders, pipettes, etc., crutches, walkers, wheelchairs, etc., physiotherapy equipment, such as exercise balls, rehabilitation belts, etc., electric toothbrushes, blood pressure monitors for home use, blood glucose meters for home use, etc, First aid kits, bandages, sterilized cotton balls, etc., dental surgical instruments, dental models, dental impression materials, etc., bandages, adhesive tapes, wound dressings, etc., orthotics, knee pads, wrist pads, etc., artificial tears, eye care kits, etc.
EN 
ZH_TW 
ZH