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    The Proposed VALID Act: A Possible Next Step in FDA’s Goal of Regulating LDTs

    This article discusses a Congressional draft proposal, The Verifying Accurate Leading-Edge IVCT Development (VALID) Act of 2018, aimed at making regulatory changes for Laboratory Developed Tests (LDTs). The authors identify a number of important points about the draft and offer analysis and commentary on proposed changes to classification and premarket review, pre-certification, registration and notification and appeals. They suggest that if the draft VALID Act became ...
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    What Can You Say?: Uncovering Trends in Recent Medical Device Enforcement Actions

    Due to multi-million-dollar (and sometimes billion-dollar) settlements, the vast majority of headlines regarding off-label promotion cases in recent years have involved drugs. Although less prominent, the US Food and Drug Administration (FDA) has steadily continued to act against medical device manufacturers for the same conduct, mostly in the form of Warning Letters. Between 1 May 2012, and 30 April 2013, FDA's Center for Devices and Radiological Health issued 24 Warning...