FDA Makes Medical Device Data Easier to Access, Use

The Food and Drug Administration is making it easier for software developers and researchers to access and use data covering the entire medical device product life cycle.

Expanding on the availability of the agency’s databases of medical device-related adverse events and recalls, the openFDA initiative now includes current data on device classification (6,000 records), 24,000 registrations of device companies/establishments, and the companies’ listings of more than 100,000 devices.

In addition, nearly 40 years-worth of data is now available on openFDA including 30,000 device premarket approvals/approval supplements and 141,000 device clearances through premarket notifications and granted de novo requests. The agency also added more details about device recalls (9,500 records going back to 2002) and adverse event reports (4.2 million records since 1991).

While this information has been available for several years in its public databases, FDA officials credit openFDA’s open-source application programming interfaces for making the publicly available data more easily accessed and queried by researchers and developers to advance scientific research and develop innovative technologies.

Also See: FDA Embracing Cloud, APIs in openFDA Initiative

In particular, the platform allows developers to integrate data from various sources and to build their own apps. For example, the agency envisions the development of smartphone apps that can search all the recalls associated with a particular type of device or find all companies that manufacture certain types of devices.

At the same time, however, FDA says it has de-identified the data so that it doesn’t contain anything that could be used to identify individuals or reveal confidential commercial information.