August 6, 2015

Mark your calendars: A new release coming soon from openFDA

openFDA Team

The FDA created openFDA to make their public information about food, drugs, and devices more accessible and useful to developers. To that end, the FDA has made a continuous effort to better understand the needs of the developer community and build on existing resources. Improvements to-date have consisted of making more data available, hardening the system, and making it easier and faster to access the data itself.

At the end of August 2015, FDA plans to make more datasets from the Center for Devices and Radiological Health (CDRH) available to the public to show the “Total Product Life Cycle” of medical devices and provide useful context. As with other openFDA efforts, this data will be released through a new application program interface (API) designed to be easily integrated by developers and researchers for the public's benefit. It's worth noting that these datasets, in addition to device adverse events reports currently available in openFDA, will have device-oriented harmonization.

These new datasets include:

  • Product Classification - A list of medical device types with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information.

  • Registration and Device Listing - A list of all medical device manufacturers registered with FDA and medical devices listed with FDA.

  • Medical Device Recalls – An expanded set of data Medical Device Recall data, compared to what is currently in openFDA. It will include recalls classified since November 1, 2002, and more information on each recall. Recalls occur when a medical device is violative and recall classification is used to indicate the risk to health.

  • 510k – The list of devices that FDA found are substantially equivalent to a legally marketed device that is not subject to premarket approval, and are cleared for commercial distribution in the US.

  • PMA – The list of devices approved for marketing through the FDA Premarket Approval (PMA) process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices.

For full access and insights into what can be done with these datasets and the new API, check back in at the end of the month.