FDA and CMS Address LDT Regulation Before Energy and Commerce Committee

By Kelly A. Briganti, Editorial Director, G2 Intelligence

Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS). The opportunity to speak at the hearing, titled “Examining the Regulation of Diagnostic Tests and Laboratory Operations,” was invitation only. The agencies presented a united front in supporting FDA oversight of LDTs.

Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, spoke about the agency’s regulation of medical devices and in vitro diagnostic devices (IVD) and explained the history leading up to the framework released last year. He also noted current proposals from the lab community that “acknowledge that LDTs must demonstrate that they are analytically valid and clinically valid.” He cited problematic LDTs like those referenced in the FDA’s report released last week (see Lab and Pathology Insider, Nov. 17, 2015), to demonstrate the need for oversight.  Shuren’s written statement to the committee reported that the FDA has reviewed public comments and feedback received and is now taking steps to coordinate with CMS on laboratory oversight, develop draft guidance regarding quality system requirements for LDTs (“to provide clarity for laboratories on how they can leverage compliance with CLIA requirements to satisfy those applicable FDA guidelines”), and work with CMS to avoid duplication of efforts in regulating laboratories. Shuren indicated in response to questioning from the committee, that the FDA intends to finalize its regulatory framework in 2016.

Patrick Conway, CMS’ deputy administrator for innovation and quality and chief medical officer, also provided testimony, explaining the roles of CMS, the FDA and the Centers for Disease Control and Prevention under CLIA. His written statement to the committee clarified that CLIA “merely regulates how and by whom the test is conducted and reported out, rather than the scientific principles behind or the clinical validity of the test system itself.” He added that CMS defers to FDA to determine clinical validity of a test.

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