One article can help you understand FDA certification.

1. History of the FDA

The FDA was established in 1906; before this, there no regulation of drugs in the United States, and they were sold through advertising; in 1938, it was required to prove the safety of drugs before they could be; in 1962, it was required to prove not only the safety but also the effectiveness of drugs before they could be sold.

The FDA defines itself as the's oldest consumer protection agency, with its origins tracing back to the establishment of the U.S. Patent and Trademark Office in 1848 and the establishment of U.S. Department of Agriculture in 1862, which took over the duties of the Patent Office in the process of chemical analysis of agricultural products. The FDA' regulatory functions began with the "Pure Food and Drug Act" passed in 1906.

2. What is FDA certification in the United States?

FDA, also known as FDA registration. It refers to the act of registering with the U.S. Food and Drug Administration for products exported to the United States, such as cosmetics, devices, food, lasers, LED lighting, etc., and ensuring that products comply with relevant U.S. standards and health and safety requirements. Some products must also submit related to be successfully registered. For example, clinical class II and class III medical products must provide 510K documents to register with the FDA.

3. What is difference between FDA certification, registration, and testing?

According to the formal definition, there is no such thing as FDA certification, but there are three other terms, such as:1. FDA approval, which generally targets more drugs, meaning that the drug is allowed to be marketed;

2. FDA registration, which appeared during the anti-terrorism period, that products must first be registered on the FDA official website, and some products need to be tested;

3. FDA testing, which is testing according to the FDA's regulations to see if the product meets the FDA's regulatory requirements. This type of testing is done by third parties, and the FDA itself does not perform any testing. They are responsible for formulating regulations and market supervision, etc.

The three terms are generally preferred by domestic callers to call FDA certification, and the FDA certification we often say refers to FDA registration number. After the FDA registration is completed, there will be a registration number, which is needed for customs clearance. The FDA only recognizes this registration number, and the FDA is usually a form provided by a third-party agency for customers, not issued by the FDA official.

4. What does U.S. FDA certification mean?

. For products exported to the United States, FDA is a mandatory requirement, and it is necessary for enterprises to complete FDA registration or testing before they can export to the United States;2. Some small countries recognize that, as small countries do not have their own regulatory requirements, they all rely on the regulations of big countries to regulate exporters;

3. product competitiveness in the same industry.

5. FDA product certification scope

1. Food products;

2. Medical device products;

3. Cosmetics;

4 Radiation, laser electronic products;

5. Nutritional supplements;

6. Traditional Chinese medicine and finished medicine

7. Nursing and health care equipment; 

Six, the role of FDA certification

 FDA has a profound impact in the United States and even in the world, and has the reputation of "the guardian of the health of Americans"; the products that are declared need undergo monitoring of 143 key detection points after the use of the product by the human body, and the monitoring of 20,000 to 30000 people for 3 to 7 years, and all products that are qualified and passed are issued FDA certification; therefore, FDA certification is recognized by the World Health Organization a relatively high food safety standard, and it is the higher honor and guarantee that international manufacturers pursue.

What issues need to be paid attention to for general FDA registration?

Iss one: Which institution issues the FDA certificate?

Answer: FDA registration does not have a certificate. Products that have been registered in the FDA will receive a registration number, and the will issue a letter of reply (with the signature of the FDA's executive director), but there is no such thing as an FDA certificate.

Issue two: Is necessary to have a designated certification laboratory for FDA testing?

Answer: FDA is an enforcement agency, not a service agency. If someone says they are a certification laboratory under the FDA then he is at least misleading consumers because the FDA does not have a service certification agency and laboratory for the public, nor does it have so-called "designated laboratories". a federal law enforcement agency, the FDA cannot engage in such activities as both referee and player. The FDA will only recognize the GMP quality of service-oriented testing laboratories, and qualified certificates to those that are qualified, but will not "designate" or recommend a particular one or several to the public.

Issue three: Is it necessary to a U.S. agent for FDA registration?

Answer: Yes, Chinese applicants must appoint a U.S. citizen (company/association) as their agent when applying for registration. This agent is responsible for the process services located in the United States, and is the medium between the FDA and the applicant.

Common misconceptions about FDA registration

. FDA registration is different from CE certification. Its certification model is different from the product testing   report certificate model of CE certification. In fact, FDA registration actually adopts a model of faith declaration, that is, you are responsible for your product's compliance with relevant standards and safety requirements, and you are registered on the U.S. federal website. If is a problem with the product, then you will bear the corresponding responsibility. Therefore, for most products, FDA registration does not exist in the sense of sending samples for testing and issuing.

2. The issue of the validity period of FDA registration: FDA registration is valid for one year. If it is more than one year, you need to re-submit registration, and the annual fee involved also needs to be paid again.

3. Is there a certificate for FDA registration? In fact, all the actions of FDA registration are done, and there is no such thing as a certificate. Then what is the FDA certificate that is circulating in the market? In fact, it is a declaratory document issued by agency that handles it, which proves that the product has gone through FDA registration.

FDA testing is for materials that come into direct or indirect contact with food. These materials include containers, packaging materials, tableware, etc., which are collectively referred to as food contact materials. Food safety issues caused by them are increasingly attracting attention from all walks of society The test of food contact materials is also called "food grade test". According to the U.S. regulations and standards, it is FDA testing.

So much has been, so what exactly is the difference between FDA registration and FDA testing, FDA certification?

In fact, from the above article, we can sum it up.

FDA registration is register on the FDA official website.