- Shenzhen Lcs Compliance Testing Laboratory Ltd.
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Shenzhen, Guangdong, China
- Main products: Product Testing & Certification, Safety/EMC/RF/SAR/Health/Chemical Testing, CE/UKCA/CCC/SRRC/FCC/UL/ISED/PSE/MIC/KC/RCM Certification, RoHS/REACH/PROP65/ERP/CPSIR Certification
What is the FDA Testing and Certification Process?
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Product Description
What is the FDA testing and certification process?
The U.S. Food and Drug Administration (FDA) is an executive agency within the U.S. Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific regulatory agency, the FDA is responsible for ensuring the safety of food, cosmetics, drugs, biologics, medical devices, and radiological products produced or imported into the United States. It is one of the earliest federal agencies primarily focused on consumer protection.
What does FDA certification scope mean?
FDA certification scope refers to products covered by law. Generally speaking, FDA certification covers products that come into close contact with people, such as food, cosmetics, and food contact materials. Whether your product falls within the scope will depend on its specific function. You can send your product information to the testing center for a quick assessment!
What does FDA Level II certification mean?
FDA Class II certification refers to Class II medical devices. FDA-certified medical devices are divided into three categories: Class I, Class II, and Class III. Class I medical devices generally serve auxiliary functions and do not directly enter the human body. Class II and Class III devices typically directly enter the human body. Class III products have the highest product risk level. Class I medical devices require general registration, while Class II and Class III devices require FDA (510(k)) registration. Class II and Class III devices are also significantly more expensive.
What does FDA food-grade certification mean?
FDA food-grade certification refers to the testing of food contact materials. Generally speaking, materials that come into contact with food include porcelain, plastic, and stainless steel. Typical products include cutlery, plates, lunch boxes, etc. After the food contact material testing is completed, a test report is provided, which is valid for a long time.
The Role of FDA Certification
The FDA has a profound influence in the United States and around the world, known as the "Guardian of American Health." Products must undergo 143 key testing points after use on 20,000 to 30,000 people for three to seven years. Only products that pass all of these tests are granted FDA certification. Therefore, FDA certification, recognized by the World Health Organization as the highest food safety standard, is a prestigious honor and guarantee sought by international manufacturers.
What does US FDA certification mean?
1. FDA certification is mandatory for exporting products to the United States. Companies must complete FDA registration or testing before exporting to the United States.
2. It is recognized by some smaller countries. Since smaller countries lack their own regulations, they often rely on the regulations of larger countries to regulate exporters.
3. It helps enhance product competitiveness among products in the same industry.
Contact Us
- Shenzhen Lcs Compliance Testing Laboratory Ltd.
- Contact nameleo tu Chat Now
- Address1&2/F, Building A, Juji Industrial Park, Yabianxuezhiwei, Shajing Street, Bao'an District, Shenzhen, Guangdong, China, Shenzhen, Guangdong
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