I. Introduction to FDA
The Food and Drug Administration (FDA) is one of the executive agencies established by the US government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, FDA's role is to ensure the safety of food, cosmetics, pharmaceuticals, biologics, medical devices, and radioactive products produced or imported in the United States. It is one of the federal agencies that protect consumers as their primary function. FDA-approved foods, pharmaceuticals, cosmetics, and medical devices are safe and effective for the human body. In nearly 100 countries, such as the United States, only commercial, clinical applications can be made through FDA-approved materials, devices, and technologies.
2. Classification of FDA certification
The FDA certification we often say usually includes the following categories:
1. FDA inspection of food contact materials
2. Laser product FDA registration
3. Medical device FDA registration
4. Cosmetics and daily necessities FDA test report
5. FDA registration of food, medicine, cosmetics and daily necessities

Four. FDA certification frequently asked questions
Question 1: Which agency is the FDA certificate issued?
A: There is no certificate for FDA registration. If the product is registered with the FDA, the registration number will be obtained. The FDA will give the applicant a reply (with the signature of the FDA Chief Executive), but there is no FDA certificate.

Question 2: Does the FDA require a designated certification laboratory test?
A: The FDA is a law enforcement agency, not a service agency. If someone says they are a FDA-certified laboratory, then he is at least misleading consumers because the FDA has neither a service-oriented certification body and a laboratory for the public, nor a so-called "designated laboratory." As a federal law enforcement agency, the FDA cannot engage in such matters as being a referee and an athlete. The FDA only recognizes the GMP quality of the service testing laboratory, and issues a qualified certificate, but does not “designate” the public or recommend a specific one or several.

Question 3: Does the FDA registration necessarily require an American agent?
A: Yes, Chinese applicants must appoint a US citizen (company/association) as their agent when registering with the FDA. The agent is responsible for the process services in the United States and is the medium for contacting the FDA and the applicant.

V. Why should companies pay attention to the FDA certification for export to the United States?
“Automatic Detainment” is a major measure implemented by the US Food and Drug Administration (FDA) for the management of imported foods. In short, it is declared “auto-detained” by the FDA. When it arrives at the US port, it must pass through the United States. After passing the laboratory inspection, it is allowed to release into the United States for sale.

Due to the small number of FDA personnel, it is impossible to conduct batch-by-batch inspections in the face of imported food, medicines, cosmetics and other products with large specifications and large quantities. The sampling rate is only 3-5%, and the sample is sampled. If the sample is qualified, the batch of products will be “detained” and disposed of.

If the problem found in the inspection is a general problem (such as trademark ineligibility, etc.), the importer may be allowed to be released after local inspection, and then released after re-inspection; if the problem found in the inspection is related to the quality of hygiene, it is not allowed. Released, or destroyed locally, or returned by the importer to the exporting country (region) and not to another country (region). In addition to random inspections, there is a measure for imported products that have potential problems. When entering the customs, batch inspections must be carried out instead of spot checks. This is the “automatic detainment” measure, and the FDA announces that it will take a product.

“Automatic detainment” measures for the following reasons:
1. At least one sample has been found to have obvious harm to human health, such as harmful elements, pesticide residues exceeding the standard, toxins, pathogenic microorganisms, chemical pollution, etc., violating the relevant provisions of low-acid canned food, or containing no Approved ingredients such as pigments.
2. If there is any information or historical record, or received a notice from the relevant departments of other countries, it indicates that the products of a certain country or region may cause harm to human health, and the FDA evaluates the above sources to confirm that the products are in The United States may also cause the same harm, and the |1FDA may also declare "automatic detainment" measures for such products.

3. Many samples fail to pass the test, but there is no obvious harm to human health, such as deterioration, odor, inclusions, unqualified labels, etc., which can be declared to the manufacturer, exporter or country (region) according to the following conditions: "Automatic detainment" measures:
(l) If a manufacturer or exporter of a product exported to the United States has at least 3 shipments in the past six months, the problem is found by the FDA, and it is “detained” and disposed of, and the unqualified sample exceeds 25% of the sample being tested. The FDA will adopt “automatic detainment” measures for such products exported to the United States by the manufacturer or exporter;

(2) If a country or region exports products to the US, at least 12 shipments in 6 months are found to be problematic when they are inspected by the FDA, and they are “detained”.
Six. FDA certification is currently a professional company
Shenzhen Hengtai Testing is currently an FDA-certified laboratory with US agents and branch offices. It can quickly register FDA for any product, and has established a large-scale FDA testing laboratory in China to test various food contact materials. . Every year, a large number of exported US products are stuck in customs due to FDA certification issues, and even the goods are destroyed, causing huge losses. Therefore, if you have any export to the US business, you may wish to consult Hengda professional FDA certified engineers to help you first. Clear obstacles, FDA professional contact: 400-000-0975
Seven. FDA certification of several models to distinguish
FDA certification is usually divided into traditional FDA registration, FDA testing and FDA assessment
FDA registration meaning: In order to ensure that the products exported to the United States meet the local FDA requirements, the company is required to do the self-declaration guarantee process. In fact, most of the FDA registrations have not been tested by third parties, but the company itself guarantees.
FDA testing: FDA testing refers to more safety testing of food contact materials, biocompatibility testing of medical products, and clinical safety testing.
FDA assessment: Take cosmetics as an example, mainly to evaluate the outer packaging and ingredient description.

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