Program Has Broad Reach -

On October 21, 2016, the Food and Drug Administration launched a webpage that contains an Allegations of Regulatory Misconduct Form to enable whistleblowers, competitors, and others to report allegations of regulatory misconduct involving medical devices quickly, easily, and anonymously. The webpage provides detailed information explaining how the form should be filled out and how FDA will use the information.

Allegations of Regulatory Misconduct -

As FDA states on its webpage, the Allegations of Regulatory Misconduct Form can be used to report any claim that a device manufacturer, or an individual marketing a device, is manufacturing or marketing a device in a manner that violates the law. This broad application means that whistleblowers can report alleged design, manufacturing, or other quality systems violations, or alleged violations of device reporting or marketing requirements (e.g., alleged off-label promotional activities), to FDA. It also means that competitors can report on one another.