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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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    PMA Advisory Panels: The Impact of FDA's Change in Policy on Voting Pattern

    This article provides a statistical analysis of Premarket Approval Application (PMA) data illustrating some new and interesting insights into the advisory panel process. Introduction The Food and Drug Administration (FDA) issues numerous guidance documents, policies and similar statements that apply to devices. These documents are not legally binding. Nevertheless, many of these documents are widely cited and incorporated into decision-making, both by FDA and industry. ...