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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.

Simunovich serves as the chief quality and regulatory officer and public affairs at BD. Based on her regulatory experience, she...

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