FDA introduction

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

FDA is a government health control agency composed of doctors, lawyers, microbiologists, pharmacologists, chemists, and statisticians who are dedicated to protecting, promoting, and improving national health. Food, medicine, cosmetics and medical appliances certified by the FDA are safe and effective for the human body. In nearly one hundred countries such as the United States, only clinical materials that are approved by the FDA can be used in commercial clinical applications.

FDA classification

1. FDA testing of food materials

"Food Contact Materials" (abbreviation: FCM) refers to the materials that the product has contact with food in normal use. Because of its direct contact with food, it is called "underwear" of food, and its safety directly affects As far as food safety is concerned, this 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:

Plastic, resin, rubber, silicone, metal, alloy, electroplating, paper, cardboard, glass, ceramic, enamel, colorant, printing paint, ink, etc.

Food contact materials and products may affect the odor, taste and color of food during contact with food, and may release a certain amount of toxic chemical components such as heavy metals and toxic additives. Ingested by the human body, endangering human health.

2. Food FDA testing

3. FDA testing of medical devices

4. Cosmetics FDA testing

5. FDA testing of drugs and biological products

Note: The business scope of NTEK is: FDA inspection of food materials + FDA inspection of laser instruments

application process

1.Consultation --- The applicant provides product information pictures or describes the products and materials required for FDA application through description.

2. Quotation --- Based on the information provided by the applicant, the technical engineer will make an assessment, determine the items to be tested, and quote to the applicant

3. After the applicant confirms the quotation, fill in the test application form and test samples

4. Sample testing-testing will be conducted in accordance with applicable FDA standards

5. Provide FDA certification report after the test

About FDA certificate

FDA registration actually adopts the integrity declaration model, that is: you are responsible for your products complying with relevant standards and safety requirements, and register on the US federal website.

Is there a certificate for FDA registration: In fact, all actions of FDA registration are done online, and there is no certificate. So what is the FDA certificate circulating on the market? In fact, it is a declarative document issued by the agency to prove that the product has been registered by the FDA.

The 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 Class 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 can be called FDA certification. FDA certification is just a colloquial term.

other

· Which agency issued the FDA certificate?

There is no certificate for FDA registration. If the product is registered with FDA, the registration number will be obtained. FDA will give the applicant a reply letter (signed by the FDA chief executive), but there is no FDA certificate.

· Does the FDA need a designated certification laboratory test?

FDA is an enforcement agency, not a service agency. If someone says that they are FDA-certified laboratories, he is at least misleading consumers, because FDA has neither a service-oriented certification body and laboratory for the public nor a so-called "designated laboratory." As a federal law enforcement agency, the FDA cannot engage in such a matter of being a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories and issue qualified certificates, but will not "designate" or recommend a specific company or companies to the public.

· Does the FDA registration require a US agent?

Yes, Chinese applicants must designate an American citizen (company / society) as their agent when registering with the FDA. This agent is responsible for the process services in the United States and is the medium for contacting FDA and the applicant.