Grounded theory was used to analyze the influencing factors of Chinese medicine enterprises applying for FDA（Food and Drug Administration） certification in the United States, and a theoretical model was constructed to provide reference for Chinese medicine enterprises to make scientific strategic decisions. Interview data from strategic decision-makers of companies that have applied for and have not applied for US FDA certification was collected on CNKI, and then root code. After open coding, spindle coding, selection coding, and comparative verification, 28 open coding, 9 categories, and 5 main categories were finally sorted out, and a theoretical model was constructed based on the analysis of the logical relationship between each category. The strategic decision of traditional Chinese medicine enterprises to apply for FDA certification is based on a consistent understanding of FDA standards and the modernization and internationalization of traditional Chinese medicine. It not only aims to enter the European and American markets as a drug, but also promotes enterprise upgrading, enhances the modernization level of the traditional Chinese medicine industry, and achieves sustainable development during the application process.