1、 Introduction to FDA

Food and Drug Administration (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 regulatory agency, 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 earliest federal agencies whose main function is to protect consumers. Food, drugs, cosmetics and medical devices certified by FDA are safe and effective for human body. In nearly 100 countries such as the United States, only the materials, devices and technologies approved by FDA can be commercialized for clinical application.

2、 Classification of FDA certification

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

1. FDA testing of food contact materials

2. Laser product FDA registration

3. FDA registration of medical devices

4. FDA test report of cosmetics and daily necessities

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

3、 FDA certification FAQs

Question 1: which agency issued the FDA certificate?

A: there is no certificate for FDA registration. If a product is registered with FDA, it will get the registration number. FDA will give the applicant a reply letter (signed by the chief executive of FDA), but there is no FDA certificate.

Question 2: does FDA need a certified laboratory?

A: FDA is a law enforcement agency, not a service agency. If someone says that they are FDA's accredited laboratories, he is at least misleading consumers, because FDA has neither a public service certification body and laboratory nor a so-called "designated laboratory". FDA, as a federal law enforcement agency, can not be engaged in this kind of work as both a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue certificates to those qualified, but will not "specify" or recommend a specific one or several to the public.

Question 3: does FDA need an American agent for registration?

A: Yes, Chinese applicants must appoint a US citizen (company / Association) as their agent when they register with FDA. The agent is responsible for process services in the United States and serves as the media for contacting FDA and applicants.

4、 Why enterprises must attach importance to the FDA certification for export to the United States

A: "automatic detention" is a major measure taken by the US Food and Drug Administration (FDA) to manage imported food. In short, when the goods declared as "automatic detention" by FDA arrive at the US port, they must pass the US laboratory inspection before they are allowed to enter the US for sale.

Due to the small number of FDA personnel, facing the situation of large specifications and large quantity of imported food, drugs, cosmetics and other products, it is impossible to carry out batch by batch inspection, but only spot check. Generally, the 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" for treatment. If the problems found in the inspection are general problems (such as unqualified trademarks, etc.), the importer can be allowed to deal with them locally and release them after re inspection; if the problems found in the inspection are related to the sanitary quality, they are not allowed to be released, or destroyed locally, or transported back to the exporting country (region) by the importer, and cannot be transported to other countries (regions). In addition to the spot check, there is another measure, that is, the imported products with potential problems must be inspected batch by batch when entering the customs, rather than spot check. This is called "automatic detention" measure. FDA announced to take "automatic detention" measure for a certain product, which can be based on the following reasons:

1. At least one sample is found to have obvious harm to human health, such as harmful elements, pesticide residues exceeding the standard, 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 information or historical records, or received notices from relevant departments of other countries, indicating that the products of a certain country or region may cause harm to human health, and FDA evaluates the above sources and confirms that such products may cause the same harm in the United States, FDA may also announce the "automatic detention" measures for such products.

3. If several samples fail to pass the inspection, but there is no obvious harm to human health, such as bad smell, inclusion, unqualified label, etc., the manufacturer, exporter or country (region) can be declared to take "automatic detention" measures according to the following conditions:

(1) If at least three batches of products exported to the United States from a certain manufacturer or exporter are found to have problems during the inspection by FDA in six months, and the unqualified samples exceed 25% of the inspected samples, FDA will take "automatic detention" measures for such products exported to the United States by the manufacturer or exporter;

(2) If at least 12 batches of products exported to the United States from a certain country or region are found to have problems during FDA inspection in six months, they will be "detained".

5、 Several modes of FDA certification

FDA certification is usually divided into traditional FDA registration, FDA testing and FDA evaluation.

Meaning of FDA registration: in order to ensure that manufacturers' products exported to the United States meet the requirements of the local FDA, enterprises are required to do the self declaration guarantee process. In fact, most of the FDA registration has not been tested by a third party, but is guaranteed by enterprises themselves.

FDA testing: FDA testing mainly refers to the safety testing of food contact materials, the biocompatibility testing of medical products, and the clinical application

Bed safety test, etc.

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