What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions

Over the past year, the US Food and Drug Administration (FDA) has steadily acted against medical device manufacturers for off-label promotion. FDA’s enforcement against medical device manufacturers has typically taken the form of Warning Letters. Between 1 May 2012, and 30 April 2013, FDA’s Center for Devices and Radiological Health issued 24 Warning Letters objecting to device promotional claims. This article analyzes these Warning Letters to provide insight into FDA’s current and emerging areas of interest and impart important lessons for the device industry to avoid future enforcement related to its promotional practices.

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