Zdrowie i gospodarka · 03/10/2014

Framework for Regulatory Oversight of Laboratory Developed Tests; Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)." This document describes 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. This document describes FDA's priorities for enforcing pre- and post- market requirements for LDTs, and the process by which FDA intends to phase in enforcement of FDA regulatory requirements for LDTs over time. This draft guidance is not final, nor is it in effect at this time.