Under Fire for Lab Rule, FDA Remains Open to Lawmaking

Healthcare policy attorney Michael Werner was quoted in a Law360 article discussing the evolving regulatory landscape for laboratory-developed tests (LDTs) following the U.S. Food and Drug Administration's (FDA) final rule reclassifying them as medical devices. Mr. Werner highlighted the potential progression of the VALID Act, or a similar legislative effort, in Congress as a means to enhance the regulatory framework for diagnostic testing. He also emphasized the importance of creating a system that encompasses current and future diagnostic testing needs without necessarily adding new rules.

"I don't want to use the word 'expanding,' but kind of rounding out the regulatory scheme for diagnostic tests," he said.

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