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US FDA Certification

Introduction to FDA:

FDA (Food and Drug Administration) certification is a certificate of conformity for food or drugs issued by the U.S. Food and Drug Administration. Due to its scientific nature and rigor, this certification has become a world-recognized standard. FDA-approved drugs can be sold not only in the United States, but also in most countries and regions in the world. FDA is the English abbreviation of U.S. Food and Drug Administration. It is an international medical review authority, authorized by the U.S. Congress, the federal government, and the highest law enforcement agency specializing in food and drug management.

 

As a global authoritative third-party testing and certification organization, BACL is recognized by the FDA (US Food and Drug Administration), and can independently complete FDA CDRH testing and certification applications for laser radiation, X-ray radiation, microwave radiation and other products, and can Complete product report, quality control report, annual report submission and factory FDA quality system audit.


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The FDA is a monitoring agency of government health regulation composed of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists, and statisticians dedicated to protecting, promoting, and enhancing the nation's health. Foods, drugs, cosmetics and medical devices certified by the FDA are safe and effective for the human body. In nearly 100 countries such as the United States, only FDA-approved materials, devices and technologies can be used for commercial clinical applications.


FDA Classification:

1. FDA testing of food materials

Food contact materials (Food Contact Materials, abbreviated as FCM) refer to the materials that products come into contact with food in normal use. Because of its direct contact with food, it is called the "intimate underwear" of food, and its safety directly affects the safety of food, which is also the most critical control point for enterprises. Products involved in food contact materials include food packaging, tableware, kitchen utensils, food processing machinery and kitchen appliances, etc. Food contact materials include: plastics, resins, rubber, silicone, metals, alloys, electroplating, paper, cardboard, glass, ceramics, Enamels, colorants, printing coatings, inks, etc.

 

Food contact materials and products may affect the smell, taste and color of food during contact with food, and may release a certain amount of toxic chemical components such as heavy metals and toxic additives. These chemical components will migrate into the food. Ingested by the human body, endangering human health.


2. Food FDA testing

3. FDA testing of medical devices

4. Cosmetic FDA testing

5. FDA testing of drugs and biological products


The difference between FDA certification, FDA testing and FDA registration:

• It can be understood in this way that FDA testing is generally aimed at these types of products: 1. Class II and III medical devices; 2. Cosmetics, daily necessities; 3. Food contact materials;

• FDA registration is generally divided into: 1. Cosmetics; 2. LED and laser products; 3. Medical devices; 4. Food; 5. Drugs;

• FDA certification is a general term for FDA testing and FDA registration, both of which can be called FDA certification, and FDA certification is just a colloquial term.