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U.S. Department of Health and Human Services

About FDA

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Description: Stand-up environment in Public Cloud to make it easier for developers, researchers, and the public to access and use the many large, important, health data sets collected by the agency. OpenFDA highlights projects using these data in both the public and private sector to further promote FDA's regulatory or scientific missions, educate the public, and save lives. openFDA provides open application programming interfaces (APIs - allows products or services to talk to other products or services), raw data downloads, documentation and examples, and a developer community for an important collection of FDA public datasets.

Accomplishment: In May 2015, OHI hosted the first openFDA Developer Challenge. This was an open call to tap public data and improve the public health developer community in order to take advantage of adverse events, recalls, and labeling datasets and to explore the range and extent of its impact for research. In August 2015, OHI provided researchers and software developers access to new high-value structured datasets with device product information such as product classification, registration and device listing, medical device recalls, 510(k)s and, Premarket Approvals (PMAs) which are now accessed via tens of millions of calls for data to be utilized in 21,000 connected systems worldwide.

Briefing Status: DELAYED

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date
A. Release drug adverse event API public beta (see Drug Adverse Event API Public Beta) 6/2/14
Completed 6/2/2014
B. Release open source code of openFDA beta 6/2/14
Completed 6/2/2014
C. Release product recalls/enforcement actions API public beta (see Product Recalls/Enforcement Actions API Public Beta) 7/15/2014
Completed 7/14/2014
D. Release structured product labels API public beta (see Structured Product Labels API Public Beta) 8/31/2014
Completed 8/18/2014
E. Improve openFDA portal design 2/28/2015
Completed 1/30/2015
F. Improve pipelines 4/30/2015
Completed 1/30/2015
G. Creation of new data sets 7/30/2015
Completed 9/1/2015
H. Enhance and refactor openFDA infrastructure 5/31/2015
Completed 4/28/2015
I. Build openFDA community 6/30/2015
Completed 7/15/2015
J. Make available downloadable openFDA harmonized datasets 1/1/2016
Completed 12/23/15
K. Harden Shiny Environment (software which allows you to host multiple applications simultaneously) 5/31/2016
On Hold
L. Enhance openFDA public documentation 5/31/2016
Completed 5/31/2016
M. Make available two new openFDA datasets by end of Calendar Year 2016 12/31/2016
Completed 12/5/2016
N. Make available one new openFDA dataset by end of Calendar Year 2017 12/31/2017
Completed 12/28/2017
O. Post two new openFDA annual performance goals (APIs) 1/31/2018
P. Enhance user interface 2/28/2018
Q. Conduct live openFDA training session 3/31/2018
R. Post openFDA training videos on the openFDA platform 4/30/2018

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.


Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.