The FDA is the abbreviation of the US Food and Drug Administration, namely the US Food and Drug Administration. The FDA has no template or standardized style for the labels of medical devices. Each product is labeled in a different way, and the labels for dealers and consumers who need reprocessing are also different. Therefore, standardized styles do not exist. However, the FDA does require products to have English labels. FDA knows the composition, uses, applicable people and usage methods of products through product labels, and supervising product labels is an important means for FDA to supervise medical device products exported to and circulated in the United States, so the compliance of labels is not limited to a certain regulation. In addition to thousands of pages of federal regulations, violations on the label are also based on the Federal Register, EAFUS database, GRAS bulletin, guidance documents, label guidelines and warning letters.
Accurately speaking, the FDA of the United States does not certify most products, but the GMP of the FDA believes that enterprises engaged in the configuration, dissemination, synthesis and processing of medical device products in the United States need to ensure that the English labels of products are compliant, including those labeling/labeling, packaging/repackaging.
If the FDA finds that the label of an enterprise violates the regulations, then the FDA has the right to question, rectify the requirements, detain the goods, refuse the entry of the goods, list the enterprises in the automatic detention of uninspected import alarms, and issue warning letters. Many enterprises are listed in the import alert because of labels, not to mention how many goods are refused entry. Therefore, it is very important to observe the English labels of products.