Regulatory Focus™ > News Articles > OpenFDA Releases Huge Trove of Medical Device Data

OpenFDA Releases Huge Trove of Medical Device Data

Posted 02 September 2015 | By Michael Mezher 

OpenFDA Releases Huge Trove of Medical Device Data

On Monday, the US Food and Drug Administration (FDA) released a vast amount of medical device data to its openFDA platform.


The openFDA initiative was originally born from an order from the White House, which called for federal agencies to implement a new "digital strategy" to make government information more accessible to the public.

The strategy focused on creating APIs – not active pharmaceutical ingredients, but application program interfaces – that would allow developers to access raw data from agencies and integrate them into new, easy-to-use software applications.

Since its launch, openFDA has added to a growing list of APIs, with endpoints related to drugs, devices and food.

Medical Device Data

Speaking at the Big Data in Biomedicine conference at Stanford University in May, FDA's Chief Health Informatics Officer Taha Kass-Hout touted some of the datasets available on openFDA, including 68,000 standard product labels (SPL) for drugs, 41,000 Recall Enterprise System (RES) records and 4.6 million adverse events for drugs from 2003 to 30 June 2014.

With Monday's release, the agency has greatly increased the amount and types of data available on openFDA pertaining to medical devices. The data include both current information on device classifications and establishment listings, as well as historical data on approvals and clearance decisions.

Data TypeNumber of Records
Device Classification6,000
Company/Establishment Registration24,000
Approvals and Supplements30,000
Clearance Decisions (510(k) and de novo)141,000
Device Recalls9,500
Adverse Event Reports4,200,000

While this data has long been available through FDA's public databases, the agency says by developers will have an easier time making use of the data, which they can use to integrate with other applications.

However, the agency cautions that "these datasets should be used in the appropriate context," and may not "return a full and complete result" for all queries. This could be because a company has changed its name, for example "Such and Such, Inc." could show up as "Such & Such Inc" on some records. In addition, because FDA has changed what information it collects from time to time, some records "may not have enough information to establish cause and effect, incidence, [or] prevalence."


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