"Pharmaceutical Information Navigator" enables the search of approximately 3 million records including recalls, defects, and warning letters from the U.S. FDA.
Berry
Berry Co., Ltd. (Headquarters: Taito-ku, Tokyo; CEO: Hiroshi Nakano) has released "U.S. FDA Information" on the medical device QMS and regulatory media "Pharmaceutical Regulatory Information Navi," which allows users to search approximately 3 million pieces of information, including recall information, adverse event reports (MAUDE), and Warning Letters published by the FDA.
Medical device manufacturers need to understand recalls, adverse events, and regulatory issues related to their products and similar devices overseas to enhance their development and quality management. However, such information is dispersed across multiple data sources like openFDA and fda.gov, making it difficult to investigate without knowledge of the U.S. medical device classification system.
"U.S. FDA Information" is a service that organizes information published by the FDA in a way that is easy for Japanese regulatory and quality assurance personnel to investigate. Users can search for the U.S. medical device classification (Product Code) from device names in Japanese and English, and check recall information and adverse event reports. It is designed to allow efficient investigation of cases related to their products, even for those who are not familiar with the FDA's complex data structure.
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