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@HHSGov recently added an #LDT FAQ to the statement on its website that @US_FDA cannot require premarket review of LDTs w/out notice-and-comment rulemaking. Here's the FAQ: hhs.gov/sites/default/… 
In the FAQ, @HHSGov states that "although FDA has asserted the authority to [mandate premarket review of LDTs], this requirement has in fact almost never been enforced. It was only being enforced during public health emergencies." This, in fact, is false and misleading.
As I recently wrote in @GenomeWeb, FDA under multiple presidents — George W. Bush, Barack Obama, & Donald Trump — has maintained that it has legal authority to regulate all diagnostics: IVDs performed at many labs and LDTs developed & performed in 1 lab. genomeweb.com/molecular-diag…
