FDA Introduction
FDA (Food and Drug Administration) certification is a certificate of conformity for food or drugs issued by the US Food and Drug Administration. Due to its scientific and rigorous nature, this certification has become a globally recognized standard. FDA certified drugs can not only be sold in the United States, but also in most countries and regions around the world. FDA is the abbreviation of the U.S. Food and Drug Administration, which is an international medical review authority authorized by the U.S. Congress, the federal government, and the highest law enforcement agency specializing in food and drug management.

The FDA is a government health regulatory monitoring agency composed of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists, and statisticians dedicated to protecting, promoting, and improving national health. FDA certified food, drugs, cosmetics, and medical devices are safe and effective for the human body. In nearly a hundred countries, including the United States, only materials, devices, and technologies that have been approved by the FDA can be commercially used in clinical practice.

FDA classification
1. FDA testing of food materials
Food Contact Materials (FCM) refer to materials that come into contact with food during normal use of a product. Due to its direct contact with food, it is known as the "close fitting underwear" of food, and its safety directly affects the safety of food, which is also the most critical control point for enterprises. The products involved in food contact materials include food packaging, tableware, kitchenware, food processing machinery, kitchen appliances, etc. Food contact materials include:
Plastics, resins, rubber, silicone, metals, alloys, electroplating, paper, cardboard, glass, ceramics, glazes, colorants, printing coatings, inks, etc.
Food contact materials and products may affect the odor, taste, and color of food during contact, and may release certain amounts of toxic chemicals such as heavy metals and additives. These chemicals can migrate into food and be ingested by the human body, posing a threat to human health.
2. Food FDA testing
3. Medical Device FDA Testing
4. Cosmetics FDA testing
5. FDA testing for drugs and biological products

Application process
1. Consultation - The applicant shall provide product information pictures or describe the products and materials required to apply to the FDA
2. Quotation - Based on the information provided by the applicant, the technical engineer will make an evaluation, determine the items that need to be tested, and provide a quotation to the applicant
3. After the applicant confirms the quotation, fill out the testing application form and test samples
4. Sample testing - Testing will be conducted in accordance with applicable FDA standards
5. Provide FDA certification report after testing is completed

Regarding FDA certification
The FDA registration actually adopts the integrity declaration model, which means that you are responsible for your product's compliance with relevant standards and safety requirements, and register it on the US federal website.
Does FDA registration have a certificate? In fact, all actions of FDA registration are done online, and there is no such thing as a certificate. So what is the FDA certificate circulating in the market? In fact, it is a declaration document issued by the agency itself, proving that the product has been registered with the FDA.

Difference between FDA certification, FDA testing, and FDA registration
It can be understood that FDA testing generally targets these types of products: 1. Class II and III medical devices; 2. Cosmetics and daily necessities; 3. Food contact materials;

FDA registration is generally divided into: 1. Cosmetics 2. LED and laser products 3. Medical devices 4. Food 5. Drugs

FDA certification is a general term for FDA testing and FDA registration, both of which can be referred to as FDA certification. FDA certification is just a common saying.

other
·Which agency issues the FDA certificate?
FDA registration does not have a certificate. By registering a product with the FDA, a registration number will be obtained, and the FDA will provide the applicant with a reply letter (signed by the FDA administrator), but there is no such thing as an FDA certificate.

·Does the FDA require designated certification laboratories for testing?
The FDA 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, as 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 referees and athletes. The FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity to those that are qualified, but will not "designate" or recommend specific one or more to the public.

·Does FDA registration necessarily require a US agent?
Yes, Chinese applicants must appoint a US citizen (company/association) as their agent when registering with the FDA. This agent is responsible for providing process services located in the United States and serves as a liaison between the FDA and the applicant.