CDRH Industry: Public Workshop Announcement - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8-9, 2015 (Registration Open)

Registration is now open for the Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) Public Workshop (January 8-9, 2015).

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 FDA’s detailed proposal is outlined in the draft guidance documents entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “FDA Notification and Medical Device Reporting for Laboratory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.

For more information, please see: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm423537.htm.