FAQ - CDx : Global Regulatory Strategy
 

Why is early regulatory engagement recommended for CDx programs?

Early regulatory interactions—such as FDA pre-submission meetings or scientific advice consultations in other regions—allow sponsors to confirm classification, evidence expectations, and development strategy. Early engagement helps reduce the risk of misaligned study designs or incomplete evidence packages.

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How do CDx regulatory pathways differ between the US, EU, China, and Japan?

Although all regions aim to ensure clinical safety and effectiveness, each has distinct regulatory frameworks. The FDA typically reviews CDx through the PMA pathway, the EU IVDR requires Notified Body review and medicinal authority consultation, China often requires local evidence, and Japan relies on coordinated drug–diagnostic review with PMDA.