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December 2020    Volume 1 Issue 9
Health Law Connections

And the Saga Continues—A Look at LDT Regulation from Past to Present

AHLA thanks the leaders of the Life Sciences Practice Group for contributing this feature article.
  • December 01, 2020
  • Cara Tolliver , Hall Render Killian Heath & Lyman PC
Pharmaceutical

The Food and Drug Administration (FDA) regulates device safety and effectiveness, including manufacture and design, while the Centers for Medicare & Medicaid Services (CMS) regulates clinical laboratory testing operations. Although the FDA has long since asserted its authority to regulate laboratory developed tests (LDTs) as medical devices, for decades, the FDA exercised discretion to refrain from enforcement of certain statutory and regulatory requirements with respect to these tests. It wasn’t until 2010 that the FDA stated its intention to pursue LDT regulation as a whole, initiating a new wave of discussion. However, despite all of the chatter on the topic, additional LDT oversight remains to be seen. Recently, the Department of Health and Human Services (HHS) announced that the FDA does not have the authority to impose premarket review requirements for LDTs absent adherence to notice-and-comment rulemaking, leaving labs opting to use LDTs without FDA test approval subject only to regulatory requirements under the Clinical Laboratory Improvement Amendments of 1988. Meanwhile, previously proposed legislation aimed at overhauling LDT oversight, namely the Verifying Accurate, Leading-edge IVCT [In Vitro Clinical Test] Development (VALID) Act, remains in limbo

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