Roselie A. Bright

OpenFDA is releasing information on medical devices that could spur innovation and advance scientific research. OpenFDA’s Application Programming Interface (API) expands the previous openFDA resources about medical device-related adverse events and recalls by incorporating information from the total medical device product life cycle. This includes current data on device classification (6000 records), 24,000 registrations of device companies and establishments, and the companies’ listings of over 100,000 devices. Data since 1976 on 30,000 device approvals and approval supplements, and 141,000 device clearance decisions (510(k) and de novo types) are now on openFDA.

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