FDA is the abbreviation of the Food and Drug Administration of the United States. FDA is one of the executive agencies established by the United States Government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). FDA is mainly divided into testing and registration in China. Medical devices, cosmetics, food and drug products need FDA registration. FDA registration can be applied directly on the official website of FDA, as well as FDA testing.
As a scientific regulatory agency, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biological agents, medical equipment and radioactive products produced or imported in the United States. It is one of the earliest federal agencies with the main function of protecting consumers. This institution is closely related to the life of every American citizen. Internationally, FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries have sought and received assistance from FDA to promote and monitor the safety of their products.
Director of the Food and Drug Administration (FDA): supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine drinks with alcohol content less than 7%, and electronic products; Testing, inspection and certification of the items that the ionizing and non-ionizing radiation generated during the use or consumption of the product affects human health and safety. According to the regulations, the above products can be sold on the market only after they have passed the FDA inspection and proved to be safe. FDA has the right to inspect the manufacturer and bring a lawsuit against the violator. According to the different product scope of supervision, it can be divided into the following main regulatory bodies:
FDA certification
In the domestic FDA certification process, the FDA certification process for food-grade materials is as follows: (For more details, see the following expanded reading)
1. Consultation - The applicant shall provide product data pictures or describe the products and materials required to apply for FDA
2. Quotation - based on the information provided by the applicant, the technical engineer will make an evaluation, determine the items to be tested, and make a quotation to the applicant
3. After confirming the quotation, the applicant shall fill in the test application form and submit it together with the test sample
4. Sample test - the test will be conducted in accordance with applicable FDA standards
5. Provide FDA certification report after test
Components of FDA
1. Center for Food Safety and Practical Nutrition (CFSAN):
The center is the department with the largest workload of FDA. It is responsible for the food safety of the whole United States except for meat, poultry and eggs under the jurisdiction of the United States Department of Agriculture. Although the United States is the safest country in the world in terms of food supply, about 76 million foodborne diseases occur every year, 325000 people need hospitalization for foodborne diseases, and about 5000 people die of foodborne diseases. The Center for Food Safety and Nutrition is committed to reducing foodborne diseases and promoting food safety. And promote various plans, such as the promotion and implementation of HACCP plan.
The functions of the center include: ensuring the safety of substances and pigments added to food; Ensure the safety of food and ingredients developed through biological processes; Responsible for the management activities in the correct identification of food (such as ingredients, nutrition and health statements) and cosmetics; Formulate corresponding policies and regulations to manage dietary supplements, infant formula and medical food; Ensure the safety of cosmetics ingredients and products, and ensure the correct identification; Supervise and standardize the after-sale behavior of the food industry; Conduct consumer education and behavior expansion; Cooperation projects with state and local governments; Coordinate international food standards and safety.
2. Center for Drug Evaluation and Research (CDER):
The center aims to ensure the safety and effectiveness of prescription drugs and over-the-counter drugs, evaluate new drugs before they go on the market, and supervise more than 10000 drugs sold on the market to ensure that products meet the constantly updated highest standards. At the same time, the center also supervises the authenticity of drug advertisements on television, radio and publications. Strictly supervise drugs and provide consumers with accurate and safe information.
3. Center for Equipment Safety and Radiological Protection Health (CDRH):
The center is ensuring the safety and effectiveness of new medical devices. Because more than 20000 enterprises around the world produce more than 80000 types of medical devices, from blood glucose monitors to artificial heart valves. These products are closely related to human life, so the center also supervises after-sales services nationwide. For some products that can produce radiation, such as microwave ovens, televisions, mobile phones, etc., the center has also determined some corresponding safety standards.
4. Center for Biological Products Evaluation and Research (CBER):
The center regulates biological products that can prevent and treat diseases, so it is more complex than chemical comprehensive drugs. It includes scientific research on the safety and effectiveness of blood, plasma, vaccines, etc.
5. Veterinary Medicine Center (CVM):
The center supervises animal food and medicine to ensure the practicality, safety and effectiveness of these products in life maintenance and pain relief.
The above contents are extracted from the MTG FDA Certification Service Center Service Manual
