We are committed to data transparency to encourage dissemination and support further research in this field. To facilitate similar research initiatives, we provide comprehensive tools and detailed reports on the datasets used in our study.
Please feel free to contact us for any further information.
We use a web scraping technique to research purposes, retrieving data about medical devices’ approval and product recalls from the Food and Drug Administration (FDA) website. The Web Scraping Guide can be found attached.
An overview of the comprehensive dataset collected through the web scraping described above is provided in the attached report. It analyzes medical devices submitted to the U.S. FDA between 2000 and 2022, covering key aspects such as authorization pathways, device characteristics, applicant firms, and product recalls. The report offers detailed insights into regulatory processes, risk classifications, and approval timelines across different device categories. It also highlights major industry trends, including the role of leading companies and the global landscape of medical device innovation.