Which regulatory innovation significantly accelerated medical product development by allowing certain devices to reach the market faster while still ensuring safety?

The journey from concept to market for medical products is a complex and highly regulated process. This poll tests your knowledge about a significant innovation in medical product development that changed how healthcare products reach patients. Understanding these milestones helps product managers appreciate the unique challenges and considerations in the healthcare industry.

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The 510(k) Premarket Notification pathway that allows devices to demonstrate substantial equivalence to existing products
The Prescription Drug User Fee Act (PDUFA) that established standard review timelines
The Humanitarian Device Exemption (HDE) for rare disease treatments
The Clinical Laboratory Improvement Amendments (CLIA) that standardized laboratory testing