Emerging Models for Regulating Laboratory-developed Tests

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When FDA published its draft framework for regulating laboratory-developed tests (LDTs), laboratory professional groups and other stakeholders voiced their concerns about the document and its potential impact on testing services. Although the FDA has not yet released any new official guidance on LDTs, behind the scenes, a number of groups have examined the agency?s draft guidance, and have developed their own solutions and proposals for moving forward with LDT regulation. These emerging models for regulating LDTs will likely inform the next steps the agency takes on this issue. During this 60-minute webinar, get the most up-to-date information on the LDT regulatory policy issues of concern to the health care community. You will also learn about the legal and political forces that are continuing to inform this debate. (This is a recorded version of an AACC live webinar that was held November 3, 2015).