This overview is excerpted from Manatt on Health, Manatt’s subscription service that provides in-depth insights and analysis focused on the legal, policy and market developments. For more information on how to subscribe to Manatt on Health, please reach out to Barret Jefferds.
On May 29, the American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration (FDA) in an effort to vacate its recent final rule that will gradually phase out FDA’s long-standing policy of enforcement discretion for laboratory-developed tests—subjecting them to the same enforcement approach as other in vitro diagnostic products (In the lawsuit, ACLA asserts that FDA lacks the authority to regulate laboratory testing services as medical devices and acted arbitrarily and capriciously in violation of the Administrative Procedure Act. If successful, the lawsuit would halt further implementation of the rule.
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