What question did this study set out to answer?

To outline the evolution of medical device regulation in the US and the current regulatory framework.

June 17, 2026JBJS Reviews

A History of US Medical Device Regulation and Current Regulatory Framework

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To outline the evolution of medical device regulation in the US and the current regulatory framework.
Reviewed historical milestones leading to FDA's establishment and authority.
Analyzed PMA and PMN processes including timelines and costs.
Evaluated the role and limitations of real-world data in regulatory applications.
PMA and PMN processes often exceed statutory timelines and costs, taking years and millions of dollars.
Real-world data may streamline evidence generation for device approvals, but it has significant limitations.
The FDA requires a fit-to-purpose approach for applications using real-world data to address bias and privacy concerns.

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Review describes FDA's evolution, current device approval processes, and implications for regulatory efficiency.

Gluski et al. (2026) studied this question.

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