FDA Releases Medical Device Database

By George Leopold

In an attempt to spur innovation and advance scientific research, the U.S. Food and Drug Administration has released a range of information related to the development and regulation of new medical devices.

Under its “OpenFDA” initiative, the agency that oversees food and drug safety also said this week its query tool API would expand previously released data about adverse events and recalls of medical devices.

As it becomes cheaper to embed intelligence, the medical electronics sector is becoming one of the fastest-growing sectors for device makers. The industry has clashed with regulators, claiming medical devices do not require the same stringent regulations as, say, a new cancer drug.

Perhaps in response to those complaints, FDA said its medical device data dump includes 6,000 records covering device classifications, 24,000 registrations by device manufacturers along with those companies’ listings of more than 100,000 medical devices.

The medical device database also includes 30,000 device approvals dating back to 1976 along with 141,000 records related to the agency’s 501(k) regulations governing medical devices.

Along with the data release, FDA officials noted in a blog post that the agency’s new API is “designed on a common platform so developers can harmonize and integrate data from various sources and build their own applications.”


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