FDA certification in the United States

The US Food and Drug Administration (FDA) is a subsidiary of the US Department of Health, Education, and Welfare, responsible for the management of drugs, food, biological products, cosmetics, veterinary drugs, medical devices, and diagnostic supplies nationwide.

The US FDA certification has a huge impact in the United States and even globally, and is known as the guardian of American health. Drug and food manufacturers around the world love and fear it, and the credibility and professional level of FDA certification in the United States have earned the trust of many experts and the public. Its strict testing and evaluation have not only provided good protection, but also sparked criticism from many pharmaceutical and food companies, accusing it of restricting invention and innovation, and being the biggest obstacle to the public's access to specific drugs, and lobbying Congress to reduce the FDA's authority.

There is no certificate for FDA certification registration in the United States. Products registered with the FDA will obtain a registration number, and the FDA will provide the applicant with a reply letter (signed by the FDA Chief Executive), but there is no mention of an FDA certificate. Chinese applicants must appoint a US citizen (company/association) as their agent when registering with the FDA. The agent is responsible for providing process services located in the United States and serves as a medium to contact the FDA and the applicant.

The US FDA certification is a law enforcement agency, not a service agency. If someone claims to be a certified laboratory under the FDA, then they are at least misleading consumers because the FDA does not have a service-oriented certification agency or laboratory for the public, nor does it have a so-called "designated laboratory". As a federal law enforcement agency, the FDA cannot engage in activities that involve both serving as a judge and an athlete. The FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity to those that meet the standards, but will not "designate" or recommend specific one or several to the public.