FDA Publishes FAQs On Final Rule Establishing Oversight Of LDTs

The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.

Since the Food and Drug Administration published its final rule in April on regulating laboratory developed tests (LDTs), the agency has been swamped with questions about how it plans to move forward and what the new regulations mean for industry and patients.

In response, the FDA has created a webpage based on the “most common questions” it has received related to LDTs.

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