The FDA has announced the availability of the draft guidance entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” (pdf available to download at: http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0360-0002).
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. To read the Federal Register Notice and to make comments electronically.
We encourage you to comments by February 2, 2015 either electronically at: http://www.regulations.gov/#%21submitComment;D=FDA-2011-D-0360-0001 or by written comment.