FDA is the abbreviation of food and drug administration. The FDA sometimes represents the U.S. Food and drug administration. FDA is authorized by the U.S. Congress or the federal government. It is a high-level law enforcement agency specializing in food and drug administration. It is also a health control agency composed of doctors, lawyers, microbiologists, chemists, statisticians and other professionals dedicated to protecting, promoting and improving national health. Many other countries seek and receive help from FDA to promote and monitor the safety of their products.
Scope of FDA products:
At present, the products managed by FDA include: food (except agricultural products), drugs, medical devices, radiation products, cosmetics, vaccines, blood products, biological agents, animal feed, veterinary drugs and tobacco.
FDA registration:
FDA registration is a process for FDA to register the enterprise and product information of the products entering the U.S. market. Its purpose mainly includes anti-terrorism and restricting the market access of the products that do not meet the requirements. FDA registration is mainly aimed at food enterprises (including the desired edible products and animal feed), medical device enterprises and products, Laser radiation enterprises and products, pharmaceutical enterprises and products, cosmetics, tobacco, these types of enterprises and products need to do FDA registration.
FDA test:
FDA testing is for some products that need to be tested to prove whether they can meet the specified requirements. FDA will formulate corresponding FDA testing regulations according to the use, actual use and contact conditions of different products, and the third-party laboratory with relevant testing ability will complete the testing. Generally, the third-party laboratory does not need FDA authorization, However, it is necessary to have relevant testing capability qualification (generally CNAs recognized in China), and the products that are involved in FDA testing usually include: product contact materials (that is, the materials that can contact with food in the whole process of food production, processing, storage, consumption, etc. shall be tested by FDA to prove that they will not cause pollution to food), Secondly, cosmetics (cosmetics need to pass the FDA test to prove that they will not cause direct or potential harm to human body). In the process of registration, some products with uncertain performance parameters need to be tested by FDA, such as laser radiation level test for laser products, and lens drop and breakage test for sunglasses
FDA certification process:
1. Product classification, suitable for test specification introduction test project, suitable for registration specification introduction for registration;
2. Fill in the application form for testing or registration;
3. Enough samples should be provided to the laboratory for testing;
4. Both parties sign quotation contract and arrange payment;
5. Issue qualification report or registration certificate after passing the test.
