The FDA has come good on its promise to make its stash of medical device data available publicly. The move means app developers can now access data on device classifications, registrations, recalls and adverse events though the openFDA application programming interface (API).
The addition of the cache of medical device data to openFDA represents one of the biggest updates to the information-sharing initiative since it got underway last year. The FDA is now sharing 6,000 device classification records, 24,000 business and site registrations and 100,000 company product listings. The stash also includes 30,000 device approvals and related supplements dating back to 1976, plus 141,000 510(k) and de novo clearance decisions. App developers can also access 9,500 recall records and 4.2 million adverse events reports, resources that date back to 2002 and 1991, respectively.
Some of the data were already available publicly in some format, but its addition to the openFDA platform is intended to make it easier for developers to repackage it in a way that is more useful to the public. The FDA cites a smartphone app that shows all recalls linked to a class of device as one use for the data. By mining another of the data sets, a similar app could list all the companies that produce a particular class of device. The idea, which is shared by the broader openFDA initiative, is to give the developer community the data and see what they make from them.
The frequency with which app developers are asking questions about how to use openFDA on its StackExchange page--15 queries have been added since June 9--and the emergence of sites such as ResearchAE.com suggest the FDA has succeeded in drumming up some level of interest in the initiative. Notably, the program has changed perceptions of the regulator. The initiative sparked discussions about federal IT strategies and was praised on Y Combinator's Hacker News when it was first unveiled last year. And last week an executive at DNAnexus described openFDA as jaw-dropping.
- read FDA's post
- and Regulatory Focus' take