The Food and Drug Administration (FDA) is the gatekeeper for health and medical products in the U.S. Applications for approvals and reports of adverse events are a matter of public record and have been available in databases that are accessible online. The FDA recently announced the launch of openFDA, a massive database that incorporates all this information and more.
openFDA is still in beta and is not yet intended for clinical use, but it does provide access to a staggering amount of data. According to the FDA, it contains 6,000 records on device classification, 24,000 company registrations, and listings of more than 100,000 devices. It has data since 1976 on 30,000 device approvals and 141,000 device clearance decisions. The 9,500 device recall records go back to 2002, and the 4.2 million adverse event reports date back to 1991. The openFDA interface provides a flexible interface that can be incorporated in other applications through the use of a application programming interface (API). The FDA has made an effort to harmonize the data as much as possible, but it is possible that a device or company might appear under different spellings. And the databases do not contain any individually-identifiable information or confidential company information.
The project is a massive one, intended to help the FDA engage the public by making this information more accessible. The agency’s hope is that openFDA will eventually become a focal point for industry and consumer feedback and discussion about health and medical products and services. This could be a powerful tool to help businesses, individuals, and the community as a whole.