Devices & Diagnostics, Health IT

FDA launches API for medical device data

The FDA, through its ongoing openFDA project, recently released a new API that will allow […]

The FDA, through its ongoing openFDA project, recently released a new API that will allow users to search for adverse event reports on medical devices going back to 1992.

“The API can be a powerful tool for generating hypotheses for further investigation or inquiry and can inform the development of safer, more effective technologies,” Taha Kass-Hout, MD, FDA’s chief health informatics officer, wrote on the agency’s website. “For example, it can help identify new, potential safety signals as well as which classes of devices may be associated with particular adverse events.”

The data will include manufacturer and user facility device experience and will be updated weekly.

But it’s not a cure-all, Dr. Kass-Hout cautioned, noting that the data set of reports is what is submitted to the FDA, not a final account on reported incidents. It may therefore contain unverified, biased, incomplete or inaccurate data and should not automatically show cause-and-effect has been proven.

“This API is the latest in a series of openFDA releases that have made publicly available data more easily accessed and queried,” Kass-Hout said. “We believe that these tools can be used by developers and researchers to make insights that fuel new, innovative products (such as mobile apps and websites), and that help protect and promote the public’s health.”

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