The right information can set your lab up for success
Download this FAQ guide to learn:
What the FDA LDT final rule means and seeks to accomplishHow 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
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.