Press Releases

AdvaMed Statement on Proposed Laboratory Developed Test Rule

WASHINGTON – Today, AdvaMed, the Medtech Association, released the following statement from President and CEO Scott Whitaker and Zach Rothstein, Executive Director of AdvaMedDx, on FDA’s recently proposed LDT rule:

“Last year, the bipartisan VALID Act was nearly passed by Congress, which would have accomplished a long-overdue modernization of the regulatory framework for diagnostics,” Whitaker said. “AdvaMed has been actively engaged in that effort because regulation of clinical diagnostics has not kept pace with advancements in the field, including those driving personalized medicine. We are evaluating FDA’s proposed rule, and we continue to urge Congress to adopt a modernized regulatory framework for diagnostics so that patients across the country have access to the best possible diagnostic tests.

“To better support patient care and public health, AdvaMed supports establishment of a single, modernized, diagnostics-specific, risk-based regulatory framework for all in vitro clinical tests (IVCTs), regardless of where developed, and overseen by FDA,” Rothstein said. “Such a framework would increase the reach of cutting-edge diagnostics, allowing patients to benefit more rapidly and broadly, and increase the confidence of patients and providers in the latest diagnostic technologies. We look forward to continuing our work on this issue.”