FDA's Lab-Developed Test Rule Faces High Hurdles

By Blake Wilson, Lowell Zeta and Randy Prebula (October 10, 2023, 5:46 PM EDT) -- In a landmark proposed rule published last month,[1] the U.S. Food and Drug Administration announced plans to make explicit that in vitro diagnostic products, including in cases where the manufacturer of the IVD is a laboratory, are medical devices as defined by the Federal Food, Drug and Cosmetic Act and will be regulated by the agency as such....

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