Introduction to FDA

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

FDA is a government health control monitoring agency, which is composed of doctors, lawyers, microbiologists, pharmacists, chemists and statisticians, which is committed to protecting, promoting and improving national health. Food, drugs, cosmetics and medical devices certified by FDA are safe and effective for human body. In nearly 100 countries, such as the United States, only the materials, devices and technologies approved by FDA can be used for commercial clinical application.

FDA classification

1. FDA testing of food materials

Plastic, resin, rubber, silica gel, metal, alloy, electroplating, paper, paperboard, glass, ceramics, glaze, colorant, printing paint, ink, etc.

Food contact materials and products may affect the smell, taste and color of food in the process of contact with food, and more likely to release a certain amount of toxic chemical components, such as heavy metals and toxic additives, which will migrate into food and be ingested by the human body, thus endangering human health.

2. Food FDA testing
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 FDA inspection of product materials + FDA inspection of laser instruments

Application process

1. Consultation - the applicant provides product information, pictures or description of the products and materials required to apply 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 to the applicant
3. The applicant shall fill in the test application form and test samples after confirming the quotation
4. Sample testing - testing will be performed in accordance with applicable FDA standards
5. Provide FDA certification report after testing

About FDA certificate

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

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

Differences between FDA certification, FDA testing and FDA registration

It can be understood that FDA testing is generally aimed at these types of products: 1; 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 general term of FDA testing and FDA registration, both of which can be called FDA certification. FDA certification is just a common saying.

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 chief executive of FDA), but there is no FDA certificate.

·   Does FDA need a certified laboratory?

FDA is a law enforcement agency, not a service agency. If someone says that they are FDA's Certification Laboratories, they are at least misleading consumers, because FDA does not have a public service certification agency and laboratory, nor does it have the so-called "designated laboratory.". As a federal law enforcement agency, FDA should not be engaged in such things as being both a referee and an athlete. FDA will only recognize the GMP quality of service testing laboratories, and issue certificates to qualified ones, but will not "specify" or recommend one or several laboratories to the public.

·   Does FDA registration require a U.S. agent?

Yes, a Chinese applicant must appoint a U.S. citizen (company / Association) as its agent when registering with FDA. The agent is responsible for the process services located in the United States, which is the medium to contact the FDA and the applicant.