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With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

(Shutterstock)

Is a warning letter from the US Food and Drug Administration to a German diagnostic manufacturer a signal that the agency might be taking a new approach to the regulation of lab-developed tests?

Perhaps, according to two legal experts.

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