1、 Introduction to FDA

The food and drug administration is referred to as FDA, which 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 authority, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biological agents, medical equipment and radiation products produced or imported in the United States. It is one of the federal agencies that are primarily responsible for protecting consumers. Food, drug, cosmetics and medical devices certified by FDA are safe and effective for human body. In nearly 100 countries, only through FDA approved materials, devices and technologies can commercial clinical applications be carried out.

2、 FDA certification classification

FDA certification, as we often call it, usually includes the following categories:

1. FDA test of food contact materials

2. FDA registration of laser products

3. FDA registration of medical devices

4. FDA test report of cosmetics and daily necessities

5. FDA registration of food, drug, cosmetics and daily necessities

3、 FDA certified Certificate Sample

4、 FDA certification FAQs

Question 1: which agency issued the FDA certificate?

A: there is no certificate for FDA registration. The product will obtain the registration number through registration with FDA. FDA will send a reply to the applicant (signed by the chief executive of FDA), but there is no FDA certificate.

Question 2: does FDA need to be tested in a certified laboratory?

A: FDA is a law enforcement agency, not a service agency. If someone says they are FDA’s accredited laboratories, he is at least misleading consumers, because the FDA does not have a public service certification body and laboratory, nor does it have a so-called “designated laboratory.”. As a federal law enforcement agency, FDA cannot do such things as being both referees and athletes. FDA will only approve the GMP quality of service testing laboratories, and issue qualified certificates, but will not “designate” or recommend specific ones or several to the public.

Question 3: does FDA registration require an American agent?

A: Yes, Chinese applicants must appoint a U.

5、 Why should enterprises attach importance to the FDA certification for export to the United States

“Automatic detention” is a major measure of the administration of imported food by the food and Drug Administration of the United States. In short, the goods declared by FDA as “automatic detention” must be inspected by the U.S. laboratory before they can be released for sale in the United States.

Due to the small number of FDA personnel, it is impossible to carry out batch by batch inspection in the face of the situation that imported food, medicine, cosmetics and other products are of large specifications and large quantity. Instead, it can only be spot check. The general rate of spot check is 3-5%. If the sample is qualified, the batch of products can be released; if the sample is unqualified, the batch of products will be “detained” and processed.

If the problems found in the inspection are general problems (such as the unqualified trademark, etc.), the importer can be allowed to release the problems after being processed locally and pass the inspection again; if the problems found in the inspection are related to the hygiene quality, they are not allowed to be released, or the local destruction is not allowed, or the importer shall return to the exporting country (region), and shall not be transferred to other countries (regions). In addition to spot check, there is also a measure that for imported products with potential problems, batch by batch inspection must be carried out when entering the customs, rather than spot check. This is “automatic detention” measure, and FDA announced to take measures on a product.

“Automatic detention” measures can be based on the following reasons:

1. at least one sample has been tested and found to be significantly harmful to human health, such as the excessive amount of harmful elements and pesticide residues, the presence of toxins, pathogenic microorganisms, chemical pollution, etc., which violates the relevant provisions of low acid canned food, or contains ingredients such as pigments without application and approval.

2. if there are data or historical records, or received a notice from relevant departments of other countries, indicating that the products in a certain country or region may cause harm to human health, and the FDA evaluates the above sources of information to confirm that such products may also cause the same harm in the United States, belfda may also announce that the products will be subject to “automatic detention” measures.

3. if several samples are unqualified after inspection, but there is no obvious harm to human health, such as bad smell, inclusions, unqualified labels, etc., the measures of “automatic detention” can be announced to the manufacturer, exporter or country (region) according to the following conditions:

(l) If at least 3 batches of goods are found to be in trouble during the inspection by FDA in 6 months for the products of a manufacturer or exporter, they shall be “detained” and processed. If the unqualified samples exceed 25% of the samples tested, the FDA will take “automatic detention” measures for such products delivered to the United States by the manufacturer or exporter;

(2) If at least 12 shipments of goods are found to be defective during FDA inspection in a country or region, they will be “detained”

6、 FDA certification is currently a professional company

Shenzhen environmental testing is currently FDA certified laboratory, with American agents and branches, can quickly register any product FDA, and has established a large FDA testing laboratory in China, which can detect all kinds of food contact materials. Every year, a large number of American products are exported to the customs due to FDA certification problems, and even the goods are destroyed, which causes huge losses. Therefore, if you have any export to the United States business, you may consult the FDA certification engineer of Environmental Measurement & measurement professional to help you clear the obstacles. FDA professional contact: 0755-23286925

7、 Several models 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 the manufacturer’s products are exported to the United States in accordance with the local FDA requirements, the self declaration guarantee process required by the enterprise is required. In fact, most of the FDA registration has not passed the third-party test, but the enterprise guarantees itself.

FDA testing: FDA testing refers to the safety test of food contact materials, biocompatibility test of medical products, clinical safety test, etc.

FDA assessment: take cosmetics as an example, mainly to evaluate the outer packaging and ingredient description.


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