FDA Looks to Boost Transparency by Enhancing Device Data Availability

September 11, 2015

With an eye toward spurring innovation and advancing research, the FDA has added a vast amount of information to a website geared toward researchers and other parties looking to gain insight into the agency’s activities.

Launched in 2014, openFDA is intended to serve as the go-to source for information on products regulated by the agency, including medical devices. The new application programming interface will expand upon adverse event and recall data made available over the past year by incorporating information from the total product lifecycle.

The website incorporates four decades of device-related data, allowing stakeholders access to information on 30,000 device approvals and approval supplements and 141,000 clearances through the 510(k) process and de novo process. It also includes 9,500 device recalls dating to 2002 and 4.2 million adverse events reports going back to 1991. Other data include 100,000 device listings, 6,000 classifications and 24,000 company registrations.

“This API is the latest in a series of openFDA releases that has made publicly available data easier to access,” according to a blog post by Taha A. Kass-Hout, chief health informatics officer and director of FDA’s Office of Health Informatics, Roselie A. Bright, who manages openFDA within the Office of Health Informatics, and Ann M. Ferriter, director of analysis and program operations in CDRH’s Office of Compliance. “FDA believes that you can use these tools to create innovative products that could help protect and promote public health. In fact, over the last year, there have been dozens of tools created using openFDA resources.” — John Bechtel