The FDA, as a U.S. government department, is responsible for the regulation of many categories (food, medical devices, cosmetics, pharmaceuticals, tobacco, radiation products, etc.) of products sold in the U.S., and adopts different regulatory means for different categories of products with different risk levels.
---- low risk level products: ordinary food, a class of 510K-exempt medical devices, OTC drugs, etc., for registration can be exported to the United States with the FDA registration number for customs clearance (cosmetics do not need FDA registration can also be exported to the United States, the FDA is currently using the VCRP voluntary registration of cosmetics management).
But this does not mean that the FDA approves or conducts any substantive review of the company and the product. By obtaining an FDA registration number, the FDA is tacitly acknowledging that the quality of the product and the quality management system of the manufacturing plant are recognized and in compliance with the FDA's regulatory requirements. As to whether the factory is truly compliant, the FDA will not audit in advance, but will be in the export and sales process after the supervision. This is exactly the opposite of China's regulatory thinking, can be simply understood as: the United States is "lenient entry and strict control", China is "strict entry and lenient control".
---- high risk products: such as most of the two or three classes of medical devices, APIs, new drugs, as well as new food additives, packaging materials, new substances, the FDA is using more stringent regulatory means, such as document review, factory inspections and so on.
We have not seen the FDA official official "FDA certification" of the word, can be understood as: different products in accordance with FDA regulations, through the submission of registration information to the registration documents to obtain a registration number, or through a third-party organization to carry out product testing or system audits, so that product quality and factory The product meets the FDA's regulatory requirements by submitting registration documents to the FDA, or by conducting product testing or system audits by third-party organizations.