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In Comments to FDA, AdvaMed Maintains Support of Agency’s Authority to Regulate LDTs


AdvaMedDx submitted comments in response to the Food and Drug Administration’s Proposed Rule: Medical Devices; Laboratory Developed Tests. AdvaMedDx is a division of AdvaMed representing companies that develop in vitro diagnostic (IVD) tests.

In the comments, AdvaMedDx outlines support for FDA’s statutory authority to regulate Laboratory Developed Tests (LDTs) while reinforcing the importance of legislative action through the bipartisan Verifying, Accurate, Leading-Edge IVCT Development (VALID) Act: “AdvaMedDx has consistently maintained that FDA possesses statutory authority to regulate LDTs as medical devices. Consequently, we believe FDA is fully within its purview to clarify the regulatory definition of in vitro diagnostics to encompass tests manufactured within a laboratory setting. While FDA, diagnostic test manufacturers, and the public would benefit significantly from comprehensive diagnostics regulatory reform, we acknowledge that such a transformation of the FDA’s regulatory environment likely necessitates an act of Congress.

“VALID or similar legislation could optimize FDA’s ability to establish a comprehensive, unified, modernized, diagnostics-specific, risk-based regulatory framework for all IVDs, including those manufactured by a laboratory, regardless of where they are developed, separate from medical devices. This framework, we firmly believe, must be risk-based to ensure that IVD regulation aligns with individual risk levels rather than the test’s developer. Adopting a modernized, risk-based framework would yield significant benefits to public health, expanding the reach of cutting-edge diagnostics, thereby enabling patients to reap the benefits more swiftly and widely, while simultaneously bolstering the confidence of patients and healthcare providers in the latest diagnostic technologies.”

The comments also called on FDA to prioritize a smooth implementation of the rule to minimize disruptions, including how FDA approaches submissions related to specimen collection devices and the potential impact to ongoing clinical studies involving investigational IVDs during the transition.

Read the full comments submitted by AdvaMedDx here.

AdvaMedDx is the only policy organization exclusively addressing issues facing the in vitro diagnostic industry in the United States and abroad. Diagnostic tests are a cornerstone of the healthcare industry: The Centers for Disease Control and Prevention estimates that 70 percent of all health care decisions rely on laboratory testing. members develop and manufacture innovative diagnostic technologies that support and advance public health and play an integral role in the work of clinical laboratories, as the tests laboratories run, including tests considered to be LDTs, often rely on instruments and equipment made by our members, or even utilize a test kit made by our members. In addition, our membership includes test developers that have pursued, and successfully obtained, FDA authorization of their own LDTs.

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