Lawsuits To Stop FDA From Overseeing LDTs Could Create Chaos, Panelist Says

 
• By Brian Bossetta

As the 6 May deadline to implement the FDA’s final rule on lab-developed tests approaches, attempts to stop the rule from taking effect are set to play out in court. A panel of experts discussed the potential impact of these legal efforts, should they be successful, at the Medtech Conference in Toronto.

Nathan Brown and Carly McWilliams speak during a session on LDT regulations at the Medtech Conference in Toronto, Ontario, on 16 October.
Nathan Brown and Carly McWilliams speak during a session on LDT regulations at the Medtech Conference in Toronto, Ontario, on 16 October. (Brian Bossetta/Citeline)

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