FDA's Final LDT Rule FAQ

 

Streamline Scientific FDA LDT FAQ

The right information can set your lab up for success

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Download this FAQ guide to learn:

  What the FDA LDT final rule means and seeks to accomplish

How the new rule affects LDTs currently in use

The phaseout stages and applicable dates for compliance

Categories of LDTs subject to enforcement discretion

Requirements for modifying existing tests or introducing new LDTs

Potential impacts of legal challenges to the FDA LDT Rule

DOWNLOAD THE FAQ

The FDA's new regulations on Laboratory Developed Tests (LDTs) are complex and can have significant impacts on your lab's operations. Understanding these changes is crucial for compliance and continued success.

Our comprehensive FAQ guide provides clear answers to help you navigate these new regulations effectively.