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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 as she

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FDA Announces Classifications On 8 Device Types

 
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Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
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More from Policy & Regulation

FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
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State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

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