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September 3, 2015

FDA Releases Medical Device Database

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.”

The FDA medical device release is also part of a larger Obama administration Open Government Initiative that includes the release of climate, energy, education and even NASA engineering and aeronautics code. Critics note, however, that the open government push has been undercut by growing government secrecy in areas like national security and global trade negotiations.

Nevertheless, FDA officials said the release of medical device data could help developers navigate the regulatory maze or survey specific market segments. For example, users of the database “could develop a smartphone app to determine all the recalls associated with a particular class of devices or find all companies that manufacture certain types of devices,” FDA officials said.

Officials also stressed that the device database does not reveal proprietary commercial information and adheres to privacy requirements.

The OpenFDA initiative is intended in part to “engage the public to advance the understanding and use of the data,” noted Taha Kass-Hout, director of FDA’s Office of Health Informatics. “This API is the latest in a series of OpenFDA releases that have made publicly available data more easily accessed and queried.

“We believe these tools can be used by developers and researchers to make insights that fuel new, innovative products that help protect and promote public health,” Kass-Hout added.

The FDA’s medical device push also seeks to leverage the open-source movement via developer communities. The effort is listed on GitHub as a “research project to provide open APIs, raw data downloads, documents and examples and a developer community for important collection of FDA public datasets.”FDA approval remains a key step in the process of developing medical device products. Another is gaining reimbursement for the cost of new products under various healthcare plans. Without reimbursement, one industry expert noted, “You don’t have a product.”

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