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FDA Prepares To Regulate LDTs, One Way Or The Other

 
• By Brian Bossetta

US FDA officials have said multiple times that they plan to move to regulate lab-developed tests, with or without Congressional action. And this week, the agency made a formal announcement of those intentions via the Unified Agenda.

NEW RULES
• Source: Shutterstock

The Food and Drug Administration has remained firm in its view that laboratory-developed tests (LDTs) should fall under its regulatory purview.

During the MedTech Conference in Boston last October Elizabeth Hillebrenner, associate director for scientific and regulatory programs at the FDA’s Center for Devices and Radiological Health (CDRH), stated as much...

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