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OpenFDA Provides Easy Access to Medical Device Data

OpenFDA Provides Easy Access to Medical Device Data

By: Sarah Massey, M.Sc.

Posted on: in News | Medical Device Clinical Trials News | Medical Device News | Medical Device Safety and Regulation News

The Food and Drug Administration (FDA) has expanded the medical device content available on their OpenFDA database. The agency’s Application Programming Interface (API) has updated the older version of the site, and included information regarding medical device recalls and reported adverse events.

OpenFDA now includes information from each product’s life cycle, including 24,000 records for device company registrations, 6,000 records for device classification and over 100,000 records for registered medical devices. The FDA says it is, “releasing information on medical devices that could spur innovation and advance scientific research.”

The FDA says the database is an easily accessible resource for information on health data collected by the agency. OpenFDA contains data from as far back as 1976, including 30,000 approval supplements and device premarket approvals (PMAs), as well as 141,000 510(k)s and de novo requests.

Details of 9,500 device recalls since 2002, and 4.2 million records regarding adverse event reports since 1991, are now available on OpenFDA. The FDA says this data has been available to the public for many years, however the new interface will make accessing the data much easier.

According to the agency’s blog, FDA Voice, “The flexible openFDA interface works 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. For example, developers could develop a smartphone app to search all the recalls associated with a particular type of device or find all companies that manufacture certain types of devices.”

Though the FDA is making a wide variety of data available to the public, it’s still taking measures to ensure some information is kept private. Personal information that could be used to identify particular individuals, as well as commercial information about the device manufacturers, are being kept confidential.

Since the way the FDA has collected information has changed over time, some data sets may be difficult to compare. For instance, the data available on device 510(k)s includes information on the company that submitted the document, as well as the device name and other information, which is released at the time of device approval.

This API is the most recent update the FDA has made to its OpenFDA platform. According to FDA Voice, “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. We hope these enhanced device data will be put to similar advantageous use.”


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