FDA introduction

FDA (Food and Drug Administration) certification is a food or drug certificate issued by the Food and Drug Administration of the US government. Due to its scientific and rigorous nature, this certification has become a world-recognized standard. 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 English abbreviation of U.S. Food and Drug Administration. It is an international medical review authority authorized by the U.S. Congress, the federal government, and is the highest law enforcement agency specializing in food and drug management.

The FDA is a government sanitation control monitoring agency dedicated to protecting, promoting, and improving people’s health, composed of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists, and statisticians. Foods, medicines, cosmetics and medical devices certified by the FDA are safe and effective for the human body. In nearly a hundred countries including the United States, only materials, devices, and technologies that have passed FDA approval can be used in commercial clinical applications.

FDA classification

1. FDA inspection of food materials

"Food Contact Materials," (abbreviated: FCM), refers to materials that come into contact with food during normal use. Because they are in direct contact with food, they are called food "underwear", and their safety directly affects When it comes to food safety, this is also the most critical control point for an enterprise. Food contact materials include food packaging, tableware, kitchen utensils, food processing machinery, kitchen appliances, etc. Food contact materials include:

Plastics, resins, rubbers, silica gels, metals, alloys, electroplating, paper, cardboard, glass, ceramics, enamels, colorants, printing coatings, inks, etc.

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

2. Food FDA inspection

3. FDA testing of medical devices

4. FDA inspection of cosmetics

5. FDA testing of drugs and biological products

Note: NTEK's business scope is: food material FDA inspection + laser equipment FDA inspection

application process

1. Consultation---The applicant provides product information pictures or describes the products and materials that need to be applied for FDA.

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

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

4. Sample test-the test will be carried out in accordance with the applicable FDA standards

5. Provide FDA certification report after the test is completed

About FDA certificate

The FDA registration actually uses the integrity declaration model, that is, you are responsible for your product's compliance with relevant standards and safety requirements, and you register on the US federal website.

Is there a certificate for FDA registration: In fact, all actions of FDA registration are registered 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 with 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, 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 the collective 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?

FDA registration does not have a certificate. After the product is registered with the FDA, a registration number will be obtained. The FDA will give the applicant a reply letter (with the signature of the FDA chief executive), but there is no FDA certificate.

Does the FDA need to be tested by a designated accredited laboratory?

The FDA is a law enforcement agency, not a service agency. If someone says that they are accredited laboratories under the FDA, then he is at least misleading consumers, because the FDA has neither public-facing service certification agencies and laboratories, nor so-called "designated laboratories." As a federal law enforcement agency, the FDA cannot engage in this kind of referee and athlete. The FDA will only recognize the GMP quality of service testing laboratories, and issue certificates of conformity if they are qualified, but will not "designate" or recommend a specific one or several to the public.

· Does FDA registration require a US agent?

Yes, Chinese applicants must designate a US 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 the FDA and the applicant.