ACLA President to Testify on Regulation of Diagnostic Tests

Washington, D.C. – American Clinical Laboratory Association (ACLA) President Susan Van Meter will testify before the House Energy and Commerce Committee’s Subcommittee on Health for a hearing titled, “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule,” today at 10:00 a.m. E.T. 

Laboratory developed test services are an indispensable pillar of the nation’s health care system. ACLA members provide high quality and innovative testing services to patients in every state across the country. However, the U.S. Food and Drug Administration’s (FDA) proposed rule would subject virtually all laboratory testing services to medical device regulation, which would limit or eliminate access to critical tests, increase health care costs, and undermine diagnostic and medical innovation.

ACLA previously submitted comments urging the FDA to withdraw its proposed rule to regulate laboratory developed tests as medical devices under the Federal Food, Drug, and Cosmetic Act. The association maintains that legislation is required for FDA to regulate laboratory developed tests and has committed to working with Congress, FDA, and other stakeholders to develop a diagnostic-specific regulatory framework. 

The hearing can be watched via the committee’s website here.

Van Meter’s written remarks, as submitted to Congress, are available here.


The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers by advocating for policies that expand access to the highest quality clinical laboratory services, improve patient outcomes, and advance the next generation of personalized care.

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