What you need to know about the shift from manufacturer-based oversight to the new risk-based approach for LDTs.
Since 2014, the FDA has been adopting a risk-based approach to regulatory oversight for LDTs which replaced the older system which focused on the type of manufacturer or laboratory involved.
In this Webinar, instructor Larry Stevens, RAC, will walk you through this new risk-based approach in detail, giving you all the information you need to anticipate the new regulations.
You’ll learn:
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