In an effort toward greater transparency, the U.S. Food and Drug Administration has released a new online tool to provide insight into its inspection, compliance, and recall data.
The new dashboard--which is hosted in a cloud environment--provides information for fiscal years 2009 to 2013, providing access to such data as warning letters, seizures and injunctions, as well as statistics for recalls. The FDA plans to update the data in the dashboard semi-annually.
Among other functionality, the FDAs dashboard allows users to: download information for additional analysis; manipulate data by selecting filters; rearrange the format of datasets and the way columns are sorted; drill down into data; and export charts and source information for further review.
The regulatory agency developed the new dashboard in response to a Presidential Memorandum on Regulatory Compliance issued in January 2011, which directed federal agencies to make publicly available compliance information easily accessible, downloadable and searchable online.
This new dynamic tool represents a departure from the downloadable spreadsheet-based datasets that we have posted in the past. Instead, the FDA data dashboard presents information in an easy-to-read graphical format, writes Douglas Stearn, director of the FDAs Office of Enforcement and Import Operations, in an Oct. 2 blog. It also provides access to the underlying data allowing anyone interested to see related data and trends.
Specifically, Stearn states that the data dashboard provides information about inspections--which the FDA is carrying out more frequently with other countries---and makes this information more readily accessible to the public so that they can better understand regulatory decisions.
In related news, the FDA yesterday issued guidance identifying cybersecurity issues that manufacturers should consider in preparing premarket submissions for medical devices to maintain information confidentiality, integrity and availability. The need for effective cybersecurity to assure medical device functionality has become more important with the increasing use of wireless, Internet- and network-connected devices and the frequent electronic exchange of medical device-related health information, states an Oct. 2 notice in the Federal Register.
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