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College of American Pathologists Supports FDA’s Role In LDTs, Not Its Rule

 
• By Brian Bossetta

The College of American Pathologists wants a US district court to scrap the FDA’s final rule that unilaterally assumes oversight of lab-developed tests, but not because the college feels the agency has no business regulating them. Helena Duncan, senior director of quality at CAP, explained the college’s position to Medtech Insight.

Arbitrary
• Source: Shutterstock

Since the US Food and Drug Administration published its April final rule assuming regulatory authority over lab-developed tests, or LDTs, the agency has attracted its share of detractors opposed to the move.

The American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) have filed lawsuits seeking to block the...

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