U.S. FDA registration refers to the process of submitting business or product information to the U.S. Food and Drug Administration (FDA) for registration. The FDA is an agency of the U.S. federal government, under the U.S. Department of Health and Human Services, whose primary responsibility is to ensure that food, drugs, medical devices, cosmetics, etc.
Since its establishment in 2007, GST General Inspection has built significant advantages in the field of testing and certification with its profound industry accumulation. The company's business covers multiple categories such as food, pharmaceuticals, health products, and medical devices, with a wide range of services. The professional team is composed of senior experts in various fields, who have a deep understanding of domestic and foreign testing and certification standards and regulations. They can quickly develop personalized testing and registration plans based on the characteristics of customer products. At the same time, the company is equipped with advanced testing equipment and has established a standardized laboratory. From sample collection to data output, every link is strictly monitored to ensure the accuracy and reliability of the testing results. In addition, GST compliance technology testing always adheres to the principle of customer first, providing one-stop services from project consultation, material preparation, testing implementation, registration and declaration, accompanying customers throughout the entire process, saving customers time and energy, and establishing an excellent reputation in the industry with high-quality service and good reputation.
FDA Registration Standards
Food contact products
The US Food and Drug Administration (FDA) requires foreign food production and processing companies to register and provide shipping notifications before exporting food to the United States. The regulatory focus covers the freshness of food, the use of additives, harmful substances such as biotoxins, the safety of seafood, food labeling, and post market tracking and warning. The registered company's products cover more than 30 categories, including alcohol, baby and children's food, bread and pastries, beverages, etc. Taking food additives as an example, companies need to provide detailed information on the ingredients, scope of use, and usage limits of the additives to ensure that they comply with FDA safety standards.
Medical device products
The FDA classifies medical devices into Class I, II, and III based on their medical use and potential harm to the human body, and the regulatory requirements for classification are gradually becoming stricter. All medical devices entering the US market require companies to register and list their products. Most Class I products only need to register, list, and implement GMP standards to enter the market; After registration and listing, Class II products also need to implement GMP and submit a 510 (k) application; Class III products need to implement GMP and submit a PMA application to the FDA. When submitting 510 (k) documents, companies need to clarify product classification and management requirements, provide testing reports that comply with mandatory US standards, and prepare application documents as required.
Cosmetics products
The FDA is implementing the Voluntary Cosmetic Registration Program (VCRP), which includes two parts: voluntary registration of cosmetic manufacturers and declaration of cosmetic ingredients. After participating in VCRP, companies can obtain important information about cosmetic ingredients, avoiding product recalls or import seizures due to ingredient issues, and also helping retailers identify safety conscious manufacturers. Enterprises are required to submit product formulas and other related information, and the FDA will review the submitted information.
Why choose general testing
Professional team support: The GST compliance testing team has a thorough understanding of FDA registration standards and regulations, and can accurately grasp the registration points of various products, providing customers with comprehensive technical support and helping them solve various problems encountered during the registration process.
One stop service experience: From early consultation and plan formulation to testing, registration and application, Tonggui Testing provides one-stop service, eliminating the need for customers to travel between multiple institutions and links, greatly saving time and energy.
Rich experience accumulation: Over the years, GST compliance technology testing has accumulated rich experience in FDA registration services in multiple fields. Familiar with the registration process and audit points, it can improve the success rate of registration and help customers' products smoothly enter the US market.
Reliable testing data: The company is equipped with advanced testing equipment, and the testing process strictly follows standards to ensure accurate and reliable testing data, providing strong data support for FDA registration.