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FDA introduction
FDA (Food and Drug Administration) certification is a certificate of conformity for food or drugs issued by the US Government Food and Drug Administration. Due to its scientific and rigorous nature, this certification has become a world-recognized standard. FDA-approved drugs 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 an international authority for medical review. It is the highest law enforcement agency authorized by the US Congress, the federal government, specializing in food and drug management.
The FDA is a government health monitoring agency dedicated to protecting, promoting, and improving national health, consisting of professionals such as doctors, lawyers, microbiologists, pharmacologists, chemists, and statisticians. FDA-certified foods, medicines, cosmetics and medical devices are safe and effective for the human body. In nearly a hundred countries such as the United States, only clinically approved clinical applications can be achieved with FDA-approved materials, devices, and technologies.
FDA classification
1.FDA inspection of food materials
"Food Contact Materials (FCM)" refers to materials that come into
contact with food during normal use. Because of its direct contact
with food, it is called "underwear" for food, and its safety
directly affects its safety. When it comes to food safety, this is
also the most critical control point for enterprises. 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, plating, paper,
cardboard, glass, ceramic, enamel, colorant, printing coating, ink,
etc.
Food contact materials and products may affect the odor, taste, and
color of food in the process of contact with food, and may also
release a certain amount of toxic chemical components such as heavy
metals and toxic additives. These chemical components will migrate
to food Ingested by human body, endangering human health.
2.Food FDA test
3.FDA inspection of medical devices
4. Cosmetics FDA test
5, FDA testing of drugs and biological products
Note: NTEK's business scope is: FDA testing of food materials + FDA
testing of laser instruments
Application process
1.Consultation --- The applicant provides product information
pictures or describes the products and materials required for FDA
application by description.
2. Quotation --- According to the information provided by the
applicant, the technical engineer will make an assessment,
determine the items to be tested, and make a quotation 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 performed in accordance with
applicable FDA standards
5.Provide FDA certification report after testing
About FDA Certificate
FDA registration actually uses the integrity declaration model,
that is, you are responsible for your products' compliance with
relevant standards and safety requirements, and register on the US
federal website.
Does the FDA registration have a certificate: In fact, all actions
of the FDA registration are registered online, there is no
certificate said. 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.
Differences between FDA certification, FDA testing, and FDA
registration
It can be understood that FDA testing generally targets these types
of products: 1. Class II or 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 collective name for FDA testing and FDA registration. Both of these can be called FDA certification. FDA certification is just a colloquial term.