I. Introduction to FDA certification
The Food and Drug Administration, or FDA for short, is one of the executive agencies established by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, the FDA's role is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products produced or imported in the United States. It was one of the earliest federal agencies to protect consumers.
Strictly speaking, there is no such thing as FDA certification. This FDA has also said it; but generally speaking, FDA certification mainly refers to the following two types:
1. FDA registration: Many products are sold to the United States for registration (such as food, drugs, medical devices, laser products, etc.), and some products must be tested before they can apply for registration;
2. FDA testing: testing the products according to FDA regulations;
The Food and Drug Administration, or FDA for short, is one of the executive agencies established by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, the FDA's role is to ensure the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products produced or imported in the United States. It was one of the earliest federal agencies to protect consumers.
two. FDA certification
Most products do not require registration fees for FDA registration, such as cosmetics, food, etc. These do not require fees. Only medical device products need to pay the US FDA fees, and all other services are required. These testing certifications gave birth to many FDA certification tests, and testing is one of them. It specializes in handling FDA testing of various products and FDA registration.
three. US FDA certification test
1. FDA testing of various food contact materials, packaging materials, etc.
2. Food FDA factory registration;
3. Cosmetic FDA factory registration or formula registration;
4. FDA registration, UDI application, Dun & Bradstreet code application for a class of medical device products;
5.FDA registration of laser products;
Four. FDA certification process
1. Distinguish products, suitable for test specification referral test items, suitable for registration specification referral for registration;
2. Fill in the application form for testing or registration;
3. Need to provide sufficient samples to the laboratory for testing;
4. The two parties sign a quotation contract and arrange payment;
5. Issue a qualification report or registration certificate after passing the test.
V. What are the benefits of the product passing the FDA certification?
The testing, inspection and certification of ionic and non-ionic radiation produced during the use or consumption of products that affect human health and safety. According to regulations, products must be FDA-tested before they can be sold on the market. FDA has the right to inspect manufacturers and prosecute offenders. Different product ranges according to regulation.
26. The role of FDA certification:
FDA has a profound impact in the United States and the world, and is known as the "Guardian of American Health." The declared products need to be monitored at 143 key detection points after the products are used by the human body, and the continuous monitoring of 2-3 million people for 3-7 years. All products that pass the inspection are issued FDA certification. Therefore, FDA certification is recognized by the World Health Organization as the highest food safety standard. It is the highest honor and guarantee pursued by international manufacturers.
The FDA International Free Sales License is not only the highest level of certification in the US FDA certification, but also the highest food and drug certification approved by the World Trade Organization (WTO). Certificate. Once this certification is obtained, the product can enter any WTO member country, and even the marketing model, the government of the host country must not interfere.
Shenzhen Zhongjianlian Testing Technology Co., Ltd. (English abbreviation: ZTL TEST, Chinese abbreviation: Zhongjianlian Testing) is an excellent new type of testing and certification agency, which provides efficient overseas certification for electronic and electrical products exported to Europe, America, Australia, Japan, The test certification items include CE certification, ERP certification, ROHS certification, FCC certification, FDA certification, IC certification, SAA certification, C-TICK certification, PSE certification, IP rating certification, SONCAP certification, etc. It can also authorize toy products EN-71, ASTM F-963, EN62115, PAHS, REACH, CCC and other certification projects.
Shenzhen Zhongjianlian Testing, focusing on global international certification, is an authoritative testing agency you deserve and trust!