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FDLI: Clinical Labs Face Uncertainty After Texas Court’s LDT Ruling

 
• By Elizabeth Orr

A Texas court's decision against US FDA regulation of lab-developed tests (LDTs) has introduced new uncertainties for clinical labs. Industry stakeholders are now worried about potential future regulations while also managing existing compliance requirements. Recent conference discussions underscored the complexities of FDA oversight.

(Andrey Popov/Shutterstock)

A Texas court struck down the US Food and Drug Administration’s proposal to regulate lab-developed tests in March, causing considerable upheaval throughout the clinical laboratory world. While many in the lab industry opposed FDA oversight due to concerns it would create an excessive regulatory burden, the reversal leaves the sector in limbo as it sketches out a new future.

Key Takeaways
  • A Texas court’s ruling against FDA regulation of lab-developed tests (LDTs) was a win for the clinical lab industry, but substantial regulatory uncertainty remains.

Speakers at the Food and Drug Law Institute (FDLI) annual meeting in Washington, DC, on 15-16 May, grappled with the...

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