FDA certification

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　　The United States Food and Drug Administration (FDA), under the United States Department of Health, Education and Welfare, is responsible for the management of drugs, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies. FDA consists of drug Bureau, Food Bureau, Veterinary Drug Bureau, Radiological Health Bureau, biological products Bureau, medical devices and diagnostic supplies Bureau and national Toxicology research Center, regional work management agencies, that is, 6 bureaus (some publications are also called 6 centers), a center and a regional management agency. The United States Food and drug Administration has a total staff of about 7,500 people, and the FDA headquarters has 1,143 people, including 350 people in the drug bureau.
　　The U.S. Food and Drug Administration is based in Washington, D.C., and Rockwell, Maryland, and has a large organization with branches all over the country. To strengthen drug quality control, the FDA divided the country into six regions, The Pacific Region (San Francisco, Seattle, Los Angeles), Southwest Region (Dallas, Denver, Kansas), Central West Region (Chicago, Minneapolis, Detroit), Northeast Region (Boston, New York, Buffalo), Mid-Atlantic Region (Philadelphia, Cincinnati, Newark, Baltimore), Southeast Region (Atlanta, Nashville, New Orleans, Orlando, Bordo) St. Gian of Lycol). Each district has a regional office, under which a number of regional offices are set up. The regional seat of the Pacific region is San Francisco, the regional seat of the Southwest region is Dallas, the regional seat of the Central West Region is Chicago, the regional seat of the Northeast region is Boston, the regional seat of the Mid-Atlantic region is Philadelphia, and the regional seat of the Southeast region is Atlanta.

　　According to the different product range regulated, it can be divided into the following main regulatory bodies:
　　1, The Center for Food Safety and Practical Nutrition (CFSAN): This center is the FDA's largest workload. It is responsible for food safety throughout the United States except for meat, poultry and eggs, which are regulated by the United States Department of Agriculture. Although the United States has one of the safest food supplies in the world, about 76 million foodborne illnesses occur each year, 325,000 people need to be hospitalized for foodborne illnesses, and about 5,000 people die from foodborne illnesses. The Center for Food Safety and Nutrition works to reduce foodborne illness and promote food safety. And promote various programs, such as: HACCP program promotion and implementation. The functions of the Centre include: ensuring the safety of substances and pigments added to food; Ensuring the safety of foods and ingredients developed through bioprocesses; Responsible for the management of the correct labelling of food products (e.g. ingredients, nutritional health claims) and cosmetics; Develop policies and regulations governing dietary supplements, infant food formulations and medical foods; Ensure the safety of cosmetic ingredients and products and ensure proper labeling; Supervise and regulate the after-sale behavior of the food industry; Conduct consumer education and behavior development; Cooperative projects with state and local governments; Coordinate international food standards and safety, etc.
　　2, the Center for Drug Evaluation and Research (CDER): The center aims to ensure the safety and effectiveness of prescription and over-the-counter drugs, evaluate new drugs before they are marketed, and monitor the more than 10,000 drugs on the market to ensure that products meet the highest standards that are constantly updated. The center also monitors the authenticity of advertisements for drugs on television, radio and in print. Strictly monitor drugs and provide consumers with accurate and safe information. 　
 　3, the Center for Device Safety and Radiation Protection Health (CDRH): The center ensures the safety and effectiveness of newly marketed medical devices. That's because more than 20,000 companies around the world make more than 80,000 medical devices of all types, from blood sugar monitors to artificial heart valves. These products are closely related to people's lives, so the center also oversees after-sales service across the country. The center has also established safety standards for products that produce radiation, such as microwave ovens, television sets and mobile phones.
　　4, the Center for Biologics Evaluation and Research (CBER): The center regulates those biologics that can prevent and treat diseases, so it is more complex than chemical synthesis drugs, and it includes scientific research on the safety and effectiveness of blood, plasma, vaccines, etc.
　　Note: The FDA is an enforcement agency, not a service agency. If someone says that they are an FDA accredited laboratory, then he is misleading consumers at the very least, because FDA is not part of the public service certification bodies and laboratories, and there is no such thing as a "designated laboratory." FDA, as a federal law enforcement agency, can not engage in this kind of referee and athlete. The FDA will only certify the GMP quality of service testing laboratories and issue certificates, but will not "designate" or recommend a specific one or several to the public, because this is contrary to the principle of fair competition in the United States society.

　　FDA certification application form
　　1.ＦＯＯＤ：Refers to ordinary food, in addition to health inspection also need to make nutrition labels. Beverages and canned foods also require FCE (Factory Registration) and SID (Product registration).
 　2.ＨＥＡＬＴＨ ＦＯＯＤ：Also known as functional food, in addition to meeting the import standards of ordinary food, but also need to have the effect of improving human function, but need to do nutrition labeling.
 　3.ＤＩＥＴＡＲＹ ＳＵＰＰＬＥＭＥＮＴ：Including amino acids, trace elements, vitamins, minerals and Chinese herbs, according to FDA regulations, it can reflect the role of traditional Chinese medicine, health care products to improve human function and prevent disease on the drug instructions, packaging and labels. The United States FDA certification has strict requirements for the description of the components and the outer packaging and labeling.
 　4.ＯＴＣ：There is no need to do new drug demonstration, but sufficient materials need to be provided to identify the active ingredient in accordance with regulations. After meeting the requirements of the FDA for over-the-counter drugs, and obtaining the United States Drug Registration number (NDC), it can be marketed as a drug in the United States market.
 　5.ＣＯＳＭＥＴＩＣ：Means an article that is rubbed, poured, sprinkled, sprayed, introduced or otherwise applied to the human body or any part thereof for the purpose of cleansing, health care, beautifying, healing or altering appearance.
 　6.Chinese herbal medicine for external use: It is composed of pure natural plants or extracts, and acts on the human body in the form of external dosage forms such as patches, lotions, suppositories, etc., and plays a role in health care and treatment.
 　7.ＧＭＰ Certification：In order to legally enter the US market, the domestic Western pharmaceutical raw materials must apply for GMP certification to the US FDA certification. The certification of GMP in the United States is also the passport for products to the international market. There are two stages:
　　  1）Compiled the DMF (DRUGMASTER FILE) and submitted it to FDA for certification, and obtained the DMF registration number.
　　  2）FDA officials conduct on-site inspections and certification.

　　List of documents to be submitted for FDA certification:
　　1. "Agreement" (signed by legal representative and stamped with company seal)

2, legal status certification documents (business license, corporate code certificate, etc., photocopy with official seal)

3. Qualification certificate or production license within the validity period (copy with official seal)

4. Formal application form

5. Product specifications

6. Product technical manual

7. Product-related drawings

8. Other documents newly required by FDA (if any)

　　FDA Certification cycle:
　　The FDA certification cycle for different products is different, and the general FDA certification cycle is 10-50 working days

　　FDA approval Scope
　　Materials such as utensils and laser products that are in direct contact with food and beverages, or in direct contact with people's mouths, must be tested and certified by FDA certification standards before they can enter the U.S. market.
         　1, food packaging materials FDA testing and certification: paper, plastic film, metal plastic aluminum foil

2, glass ceramic products FDA testing and certification: all kinds of glass ceramic POTS, bowls, plates, spoons, POTS, cups, bottles, POTS and other products

3, food grade plastic products FDA testing and certification: contact with food or direct entry of plastic materials, mainly including: Nylon, ABS, ACRY, PU, PE, PC, PVC, PP, PR, PET, PO, PS, PSU, POM, PPS, EVA, SAN, SMM, EVA, BS, MEL, COPP, KRAT, ACRY and so on

4. Food

5. Medical equipment

6. Medicine

7. Food additives

8. Drinks

9. Food related materials
　      　10, coating products FDA testing and certification: coating on the food contact surface of paraffin copolymer, PVC paint, powder paint, ink, etc.

11, plumbing hardware products FDA testing and certification: with drinking water, tap water contact faucets, pipes, containers, valves, water heaters and so on

12, rubber resin products FDA testing and certification

13, chemical additives FDA testing certification: pigments, preservatives, antioxidants, surfactants and so on.

14, laser products: DVD drive, DVD disc player, laser pointer, laser pointer, laser diode, CRT picture tube, etc.