The U.S. Food and Drug Administration (FDA) has introduced a groundbreaking rule aimed at regulating Laboratory Developed Tests (LDTs) as medical devices. For manufacturers selling LDTs in the United States, this represents a significant shift requiring careful attention and strategic planning to ensure compliance. This article distills insights from NSF experts Janet Book and Jacob Foster, who shared critical strategies for navigating this new regulatory environment in a recent webinar.
Unlocking success: best practices for manufacturers under the FDA’s new LDT rule
For manufacturers selling LDTs in the United States, this represents a significant shift requiring careful attention and strategic planning to ensure compliance. This article distills insights from NSF experts Janet Book and Jacob Foster, who shared critical strategies for navigating this new regulatory environment in a recent webinar
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