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

By: Taha Kass-Hout, M.D., M.S., Roselie A. Bright, Sc.D., M.S., P.M.P. and Ann Ferriter

Taha Kass-Hout

Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics, Office of the Chief Scientist

OpenFDA is releasing information on medical devices that could spur innovation and advance scientific research.

OpenFDA’s Application Programming Interface (API) 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 FDA. Data since 1976 on 30,000 device premarket approvals (PMAs) and approval supplements, and 141,000 device clearances through premarket notifications (510(k)s) 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.

Roselie Bright

Roselie A. Bright, Sc.D., M.S., P.M.P., manages openFDA and is in FDA’s Office of Health Informatics, Office of the Chief Scientist

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. 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.

Ann Ferriter

Ann M. Ferriter, FDA’s Director of Analysis and Program Operations, Office of Compliance, Center for Devices and Radiological Health

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 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 API is the latest in a series of openFDA releases that has made publicly available data easier to access. FDA believes that you can use these tools to create innovative products that could help protect and promote public health. In fact, over the last 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.

Taha A. Kass-Hout, M.D., M.S., is Chief Health Informatics Officer and Director of FDA’s Office of Health Informatics, Office of the Chief Scientist

Roselie A. Bright, Sc.D., M.S., P.M.P., manages openFDA and is in FDA’s Office of Health Informatics, Office of the Chief Scientist

Ann M. Ferriter is FDA’s Director of Analysis and Program Operations, Office of Compliance, Center for Devices and Radiological Health

For more information:

Premarket Approval (PMA)

Premarket Notification 510(k)

New Section 513(f)(2) – Evaluation of Automatic Class III Designation, Guidance for Industry and CDRH Staff

What is a Medical Device Recall?

Manufacturer and User Facility Device Experience Database – (MAUDE)

Medical Device Databases

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