April Rule, Or April Fool? Will Final LDT Rule Be Ready On Time?

 
• By Brian Bossetta

The White House has indicated that it expects the US FDA to publish its final rule on regulating lab-developed tests by April. But first, the agency must consider thousands of comments that have poured in since the proposal was published in October.

APRIL FOOL
• Source: Shutterstock

As the Food and Drug Administration sifts through a tsunami of comments on its proposal to regulate lab-developed tests as medical devices, some are skeptical the agency can meet the White House’s expectations for finalizing the rule by April.

Allyson Mullen, a director at the law firm Hyman, Phelps & McNamara, who provides counsel to medical device manufacturers, says...

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