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FDA

FDA Compliance

openFDA Makes Medical Device-Related Data Easier to Access and Use

FDA believes you can use openFDA to create products that promote public health

Published: Thursday, September 24, 2015 - 11:05

(FDA: Silver Spring, MD) -- openFDA is releasing information on medical devices that could spur innovation and advance scientific research.

openFDA’s application program interface expands on the previous openFDA resources concerning medical device-related adverse events and recalls by incorporating information from the medical device product life cycle. This includes current data on device classification (6,000 records), 24,000 registrations of device companies and establishments, and the companies’ listings of more than 100,000 devices.

openFDA is a project that provides easy access to the many large, important, health data sets collected by the FDA. Data since 1976 on 30,000 device premarket approvals and approval supplements, and 141,000 device clearances through premarket 510(k) notifications and granted de novo requests are now available on openFDA. Additionally, more details about device recalls (9,500 records going back to 2002) and adverse event reports (4.2 million records since 1991) were added. Although this information has been available in our public databases for many years, now developers can more easily access and use the data.

The flexible openFDA interface works well even when greater demands are made on it and is designed on a common platform so developers can harmonize and integrate data from various sources and build their own applications. 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.

However, there are some important safeguards to the data released. For instance, the information doesn’t contain anything that potentially could be used to identify individuals or reveal confidential commercial information.

Everything available in these datasets should be understood in the appropriate context. The 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.

Some datasets are snapshots in time. The 510(k) dataset, for instance, shows who submitted the 510(k), the device name, and other information at the time of clearance. Moreover, the types of information that the FDA has collected has changed over the years, which can make it difficult to look at data over time. Also, the data may not have enough information to establish cause and effect, incidence, or prevalence.

By design, openFDA is a research and development project that draws on community involvement. We are active in the openFDA communities on GitHub and StackExchange, and encourage researchers, scientists, and developers to participate in those communities. This application program interface is the latest in a series of openFDA releases that has made publicly available data easier to access. The FDA believes you can use these tools to create innovative products that could help protect and promote public health. In fact, during the past year, there have been dozens of tools created using openFDA resources. We hope these enhanced device data will be put to similar advantageous use. Together, we can make openFDA an even more useful and powerful resource for all.

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FDA

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.