WASHINGTON, DC - Energy and Commerce Committee Chairman Fred Upton (R-MI) today responded to the FDA’s decision not to finalize guidance on laboratory developed tests (LDTs). LDTs have been an important area of concern for the committee. The committee has held multiple hearings on LDTs (September 2014, November 2015 ), and has done extensive work to find a bipartisan path forward.
Chairman Upton commented, “We appreciate FDA’s decision to refrain from finalizing its guidance on LDTs. It was the right call. Our committee has consistently believed that applying medical device regulations to LDTs via non-binding guidance documents is not the best approach. Diagnostics, regardless of whether they are developed in a lab or by a manufacturer, are critical to advancing precision medicine and raise complex policy issues the committee has been grappling with on a bipartisan basis. Working together, we are forging significant consensus among a number of patient groups, labs, and manufacturers around a 21st century approach uniquely designed with all diagnostic tests in mind from the outset. We look forward to discussing our efforts to date with additional stakeholders and completing our work next year."
