Sep 10, 2015

The US Food and Drug Administration has published a massive cache of data pertaining to medical device classification, registration and related data through its openFDA application programming interface (API).

The data includes 6000 records on device classification; 24,000 records on device company and establishment registrations; and more than 100,000 device listings. The agency has also added 9500 records on device recalls and more than four million adverse event reports to the openFDA platform.

The FDA had previously made this information available on public databases, but has now optimized and consolidated these records for better public accessibility and usability. The agency did so in order to foster development of innovative devices and technologies as well as better support research into device performance.

“The flexible openFDA interface functions well even when greater demands are made on it, and is designed on a common platform so developers can harmonize and integrate data from various sources and build their own applications,” states the regulator. “For example, they could develop a smartphone app to determine all the recalls associated with a particular class of devices or find all companies that manufacture certain types of devices.”

The newly released data does not include any proprietary commercial information on FDA registrants or their devices, according to the agency.


  • Stewart Eisenhart