Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
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What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
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How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
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Are Current Regulations Keeping Labs from Benefiting from AI?
Though needed to protect data and patient privacy, some in the industry say that more flexibility is needed
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Lab Enforcement: Current Trends and Compliance Tips for Labs
This Lab Institute presentation shares recent enforcement trends and how labs can avoid compliance risks related to these issues.