FDA Adds Huge Amount Of Medical Device Data To openFDA Platform

By Jof Enriquez,
Follow me on Twitter @jofenriq

The U.S. Food and Drug Administration (FDA) has released a vast amount of data pertaining to medical devices to its openFDA platform, an initiative that brings information to the public domain via an application programming interface (API).

The openFDA initiative was created through a White House order that required federal agencies to implement a digital strategy to make information more transparent to the public, according to the Regulatory Affairs Professional Society (RAPS). Through the creation of various APIs for drugs, devices, and food, researchers and developers can use harmonized data sets to develop new software applications.

FDA previously released massive data sets pertaining to drugs, and scarcer data regarding medical devices was also made available. Now, openFDA’s API has added a substantial amount of data that expands on medical device-related adverse events and recalls by incorporating information from the total medical device product life cycle, according to an FDA blog post.

Here's a breakdown of the additional data, per FDA:

• Device classification: 6,000 records
• Device companies and establishments: 24,000 registrations
• Device listings: 100,000 devices
• Device premarket approvals (PMAs) and supplements (since 1976): 30,000 records
• Device clearance decisions (510(k) and de novo): 141,000 clearances
• Device recalls (since 2002): 9,500 records
• Adverse event reports (since 1991): 4.2 million records

FDA says the openFDA platform makes it easier and faster for researchers and developers to re-construct data from disparate sources, via a flexible and open API, and then develop new tools to protect public health.

"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," states the FDA blog post. The agency says dozens of new tools have been created using openFDA data over the past year.

In an interview with Government Technology, Taha A. Kass-Hout, M.D., M.S., who is chief health informatics officer and director of FDA’s Office of Health Informatics, Office of the Chief Scientist, explained further how this API was developed and applied.

"We chose to use a search-based application program interface (API) that gives developers the ability to search through text within the data. The open source code and documentation are shared on GitHub. We hope this will encourage the industry to move to this API and big data approach," said Dr. Kass-Hout in the interview.

"At the same time, we wanted to stop at the API and not force one set of applications or another on people. This method allows them to build their own applications on top of openFDA, giving them flexibility to determine what types of data they would like to search and how they would like to present that data to end users. This enables a wide variety of applications to be built on one common platform."

However, the FDA cautions users of openData that "everything available in these data sets should be understood in the appropriate context. FDA has harmonized the data, but there may be instances when a query does not return a full and complete result. For example, if the name of a manufacturer is listed with different spellings, some variations may not be captured in the result."

Also, because FDA has changed the type and amount of data requirements over the years, these "data may not have enough information to establish cause and effect, incidence, nor prevalence." Regardless, FDA reassured that data contained in openFDA would not identify patient data or leak sensitive commercial information.