Exploration and Enlightenment of the Latest LDT Regulatory Policy of the US FDA
Analyzing the FDA's 2024 LDT new policy,comparing and studying its regulatory framework,background,policy tools,implementation measures,and regulatory ideas,and exploring its implications.Exploring the risk-based and historical continuity hierarchical management ideas in the latest regulatory policies of the US FDA on LDT,to provide a research basis and reference for related work in China.In its new policy on LDT,FDA would phase out its general enforcement discretion enforced for many years based on risk management and taking into account historical continuity.Based on the risk characteristics and application practice of some special products,a policy of partially retaining discretion is formulated to seek the best balance between safety and effectiveness,patient accessibility,laboratory burden,regulatory resources and other factors.Its work ideas can be used as a reference for relevant work in China.
laboratory developed tests(LDT)enforcement discretionrisk analysisphaseout policy
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