1. Medtech Insight

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)

When Congress at the end of 2022 failed to pass the VALID Act that would have establishing perimeters for the US Food and Drug Administration to regulate laboratory developed tests, it set in motion a chain of events that could spell pandemonium.

Key Takeaways

Ongoing lawsuits could upend the LDT industry, potentially leading to renewed interest in Congressional action.

The outcome will depend on the exact language of legal rulings, as well as actions taken under a new administration.

Scott Garrett, a partner in medtech-focused investment firm Water Street Healthcare Partners, believes some criticisms of the final rule are misguided.

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