The so-called FDA510K, there is no special significance, it is the United States Food, Drugs and Cosmetics (FD&C) Action Committee of a chapter of the bill, and the chapter of the bill, it happens to be in the United States FD&CAct Chapter 510, so many people habitually refer to him as 510K;
And this is the United States Food, Drug and Cosmetic (FD&C) Action Committee Act, so everyone again like to call it do FDA510K, which is called the origin of FDA510K.
The FDA's responsibility is to ensure that the U.S. domestic production or imported food, cosmetics, drugs, biological agents, medical devices and radiation products, medical products in the FDA certification, generally divided into two kinds, one is 510K exemption outside the medical products, such products do medical FDA certification is relatively simple, fast process, can be fast to obtain the registration number, to help the product marketing Expanded information:
This is the first time that the FDA has issued an FDA-approved product. p>I. Cosmetic Certification
The FDA's Office of Cosmetics and Colors has developed a voluntary registration program for cosmetics at the request of the cosmetic industry. The program consists of two parts: voluntary registration of cosmetic manufacturers and cosmetic ingredient declarations.
Manufacturers voluntarily register and obtain a registration number does not mean that the FDA approval of the manufacturer or its products, the FDA also does not allow manufacturers to use participation in the VCRP or access to the registration number or listing number of commercial promotion; but manufacturers can participate in the VCRP through the direct access to the following benefits:
Second, the drug certification
The FDA on the pharmaceutical products have a complete set of The FDA has a complete set of certification procedures for pharmaceutical products in order to ensure the safety and efficacy of new drugs, the program is as follows:
1, investigational new drug application (IND)
When the pharmaceutical company to the FDA to submit the IND, the FDA's monitoring of the new drug has begun. At this time, the human trials of the new drug have not yet begun, the FDA mainly review the in vitro safety data and animal testing data to determine whether the drug is safe enough to enter the human trial stage.
2, human trials
Human trials **** divided into four phases. The first phase is to test the safety of the drug, the main side effects, metabolic mechanism, etc., the number of samples is generally less than this 00. The second phase is to test the effectiveness of the drug, in order to determine whether the drug can be effective in the human body. At the same time, the safety and toxic side effects of the drug are also closely observed. The sample size of phase II experiments is generally less than 300.
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