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Rulemaking Can Only Do So Much: Stakeholders Weigh In On LDT Rule

 
• By Hannah Daniel

Investors and business executives weighed in on the FDA’s proposed rule on LDTs during a panel at the Medtech Conference on 9 October. 

• Source: Citeline

The new proposed rule for the US Food and Drug Administration’s oversight of laboratory developed tests (LDTs) can’t solve everything, Becton Dickinson’s Ami Simunovich said during AdvaMed’s Medtech Conference on 9 October.

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South Korea Adds Digital Health Rules To Already Complicated Regulatory Landscape

 
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More from Conferences

Former FDA Head Tells Heart Society To ‘Get Involved’ To Protect Health Innovation

 
• By Elizabeth Orr

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‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

 
• By Natasha Barrow

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.