Which regulatory innovation dramatically changed medical product development by introducing a risk-based classification system for medical devices?

The development of medical products has evolved dramatically over the decades, with changing methodologies, regulations, and technologies. This poll tests your knowledge about key transformations in how medical devices and pharmaceuticals move from concept to market. Understanding these developments is crucial for professionals in healthcare product management and medical innovation.

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The 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act
The 1962 Kefauver-Harris Amendments requiring proof of efficacy
The 1997 FDA Modernization Act introducing 510(k) pathways
The 2016 21st Century Cures Act expediting approval processes