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Public Workshop - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

January 8 - 9, 2015

Natcher Center at the National Institutes of Health (NIH) Campus
Bethesda, MD

Event Website: Click here

The purpose of this workshop is to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity for public comment. FDA’s detailed proposal is outlined in the draft guidance documents entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)” issued October 3, 2014.

The purpose of the workshop is to obtain feedback from all stakeholders on FDA’s proposal so that it can be refined in the best interest of public health.

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