The U.S. Food and Drug Administration (Food and Drug Administration) referred to as FDA is one of the executive agencies established by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific management agency, the FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological agents, medical equipment, and radiological products produced or imported in the United States. It is one of the federal agencies whose main function is to protect consumers. Foods, medicines, cosmetics and medical devices certified by the FDA are safe and effective for the human body. In nearly a hundred countries including the United States, only materials, devices, and technologies that have passed FDA approval can be used in commercial clinical applications.
Classification of FDA certification
The FDA certification we often say usually includes the following types:
1. FDA testing of food contact materials;
2. FDA registration of laser products;
3. FDA registration of medical devices;
4. FDA inspection report for cosmetics and daily necessities;
5. FDA registration for food, medicine, cosmetics and daily necessities.
FDA registration does not have a certificate. After the product is registered with the FDA, a registration number will be obtained. The FDA will give the applicant a reply letter (with the signature of the FDA chief executive), but there is no FDA certificate.
The FDA is a law enforcement agency, not a service agency. If someone says that they are accredited laboratories under the FDA, then he is at least misleading consumers, because the FDA has neither public-facing service certification agencies and laboratories, nor so-called "designated laboratories." The FDA, as a federal law enforcement agency, cannot engage in such things as both a referee and an athlete. The FDA will only recognize the GMP quality of service testing laboratories, and issue certificates of conformity if they are qualified, but will not "designate" or recommend a specific one or several to the public.
Chinese applicants must designate a U.S. citizen (company/society) as their agent when registering with the FDA. This agent is responsible for the process services located in the United States and is the medium for contacting the FDA and the applicant.
Why companies must pay attention to FDA certification for export to the United States
"Automatic detention" is a major measure of the U.S. Food and Drug Administration (FDA) for the management of imported food. In short, goods declared as "automatic detention" by the FDA must pass through the U.S. when they arrive at a U.S. port. Only after passing the laboratory inspection, can they be released into the United States for sale.
Due to the small number of FDA personnel, facing the situation of imported food, drugs, cosmetics and other products with large specifications and large quantities, it is impossible to conduct batch-by-batch inspections, but only random inspections. The general random inspection rate is 3-5%. If it is qualified, the batch of products can be released; if the sample is not qualified, the batch of products will be "detained" and processed.
If the problem found in the inspection is a general problem (such as unqualified trademarks, etc.), the importer can be allowed to deal with it locally and be released after re-inspection; if the problem found in the inspection is related to hygienic quality, it is not allowed Released, or destroyed locally, or shipped back to the exporting country (region) by the importer, and cannot be transferred to another country (region). In addition to random inspections, there is another measure, that is, for imported products with potential problems, they must be inspected on a batch-by-batch basis instead of random inspections. This is an "automatic detention" measure, and the FDA announced that it will take a certain product.
"Automatic detention", measures can be based on the following reasons:
1. At least one sample was found to have obvious hazards to human health after inspection, such as harmful elements, excessive pesticide residues, toxins, pathogenic microorganisms, chemical pollution, etc., violated the relevant regulations of low-acid canned food, or contained undesirable Declare approved ingredients such as pigments.
2. If there are data or historical records, or notifications from the relevant departments of other countries, indicating that the products of a certain country or region may be harmful to human health, and the FDA has evaluated the above-mentioned sources of information to confirm that such products are in The United States may also cause the same harm, and the FDA may also announce the adoption of "automatic detention" measures for such products.
3. Many samples have been unqualified after inspection, but there is no obvious hazard to human health, such as deterioration and odor, inclusions, unqualified labels, etc., which can be announced to manufacturers, exporters or countries (regions) according to the following circumstances "Automatic detention" measures:
If a manufacturer or exporter’s products exported to the U.S. have at least 3 batches of goods inspected by the FDA in 6 months, problems are found, and they are “detained” and processed, and the unqualified samples exceed 25% of the inspected samples, the FDA will Take "automatic detention" measures for such products exported to the United States by the manufacturer or exporter;
If there are at least 12 shipments of products exported to the U.S. from a certain country or region that are found to be inspected by the FDA during the six months, they will be "detained"
Several modes of FDA certification
FDA certification is usually divided into traditional FDA registration, FDA testing and FDA evaluation
FDA registration meaning: In order to ensure that manufacturers' products exported to the United States meet the local FDA requirements, companies are required to make a self-declaration guarantee process. In fact, most of the FDA registrations have not undergone third-party testing, but the companies themselves guarantee.
FDA testing: FDA testing refers more to the safety testing of food contact materials, biocompatibility testing of medical products, and clinical safety testing.
FDA evaluation: Take cosmetics as an example, mainly to evaluate the outer packaging and ingredient description.
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