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Certification in North America

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Address:UNIT 4, 7/F, BRIGHT WAY TOWER, NO. 33 MONG KOK ROAD, KOWLOON, HONGKONG

Telephone:0755-26499308

Phone:13530363894

Email:ktssales@126.com

FDA certification

Release time:2020-03-09

About FDA (Food and Drug Administration) Agency The Food and Drug Administration...
FDA certification

About FDA (Food and Drug Administration)

Food and Drug Administration (FDA)

The FDA is one of the executive agencies set up by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS).


As a scientific regulatory agency, the FDA's role is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products produced or imported in the United States. It was one of the first federal agencies to focus on consumer protection. The agency is relevant to the lives of every American citizen. Internationally, the FDA is recognized as one of the world's largest food and drug regulatory agencies. Many other countries seek and receive help from the FDA to promote and monitor the safety of their own products.

Food and Drug Administration (FDA) Supervisor: Supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine and beverages with less than 7% alcohol and electronic products; products in use Testing, inspection and certification of ionic and non-ionic radiation that affects human health and safety during the consumption or consumption process. According to the regulations, the above products can only be sold on the market after they have been proven safe by FDA inspection. FDA has the right to inspect manufacturers and prosecute offenders. According to the different product scopes regulated, it can be divided into the following major regulators:

1.Food Safety and Practical Nutrition Center (CFSAN):

The center is the department with the largest workload for FDA. It is responsible for food safety throughout the 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 food supply in the world, about 76 million foodborne illnesses occur every year, 325,000 people need hospitalization due to foodborne diseases, and about 5,000 people Died from foodborne illness. The Center for Food Safety and Nutrition is committed to reducing foodborne illness and promoting food safety. And promote various plans, such as: the implementation of the HACCP plan.

The functions of the center include: ensuring the safety of substances and pigments added to food; ensuring the safety of foods and ingredients developed through biotechnology; responsible for management activities in the correct identification of foods (such as ingredients, nutrition and health declarations) and cosmetics; Formulate corresponding policies and regulations to manage dietary supplements, infant food formulas, and medical foods; ensure the safety of cosmetic ingredients and products, ensure correct labeling; monitor and regulate after-sale behavior in the food industry; conduct consumer education and behavior expansion; and Cooperative projects between state and local governments; coordination of international food standards and safety, etc.


2. Center for Drug Evaluation and Research (CDER):

The center aims to ensure the safety and effectiveness of prescription and over-the-counter medicines, evaluate new medicines before they are launched, and monitor more than 10,000 medicines on the market to ensure that products meet the highest standards for continuous updates. It also oversees the authenticity of advertisements for medicines on television, radio and publications. Strictly monitor drugs and provide consumers with accurate and safe information.


3. Center for Equipment Safety and Radiation Protection Health (CDRH):

The center is ensuring the safety and effectiveness of newly marketed medical devices. Because more than 20,000 companies around the world produce more than 80,000 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 service 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.Biological Product Evaluation and Research Center (CBER):

The center supervises 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 Drug Center (CVM):

The center oversees animal foods and medicines to ensure the usefulness, safety, and effectiveness of these products in maintaining life and reducing pain.


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