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.
Other
· Which agency issued the FDA certificate?
There is no certificate for FDA registration. Products registered with the FDA will obtain a registration number. The FDA will return a letter to the applicant (with the signature of the FDA chief executive), but there is no FDA certificate.
Does the FDA need a designated accredited laboratory test?
The FDA is an enforcement agency, not a service agency. If someone says they are FDA-accredited laboratories, then he is at least misleading consumers, because the FDA has neither a service-oriented certification body or laboratory for the public, nor a so-called "designated laboratory". The FDA, as a federal law enforcement agency, may not engage in such a role as a referee and an athlete. The FDA will only recognize the GMP quality of service testing laboratories and issue certificates of conformity, but will not "designate" or recommend a specific one or several to the public.
· Does FDA registration necessarily require a U.S. agent?
Yes, Chinese applicants must appoint an American citizen (company / community) as their agent when registering with the FDA. This agent is responsible for the process services located in the United States and is the medium for contacting the FDA with the applicant.
NTEK Group
Third party certification body
Hot Line
400-800-6106
Official account
Submit successfully