AdvaMedDx Statement On LDT Guidance

You are here

AdvaMedDx Statement On LDT Guidance

November 21, 2016

WASHINGTON, D.C. – Andrew Fish, executive director of AdvaMedDx, today issued the following statement regarding FDA’s decision not to release at this time a final guidance on oversight of laboratory developed tests:

“AdvaMedDx is disappointed that FDA final guidance on LDT oversight is not forthcoming at this time, but we are encouraged by congressional interest in addressing longstanding questions about LDT regulation in the context of broader diagnostics reform legislation.

“We are committed to continuing to work with all parties, including Congress and key stakeholders, on legislation that assures risk-based oversight of all diagnostics, including LDTs.

“It is imperative that this legislation recognizes FDA's critical oversight role and serves public health and innovation, and we hope FDA will share its current thinking on LDT oversight to help inform the legislative discussion.”