Passage of the Medical Device Amendments Act in 1976 confirmed the US Food and Drug Administration’s (FDA’s) primary responsibility for evaluating the safety and effectiveness of medical devices in the United States.1 Although there have been modest legislative updates in the ensuing decades, the broad structure of the FDA’s risk-based framework for premarket evaluation has remained largely unchanged.2 High-risk (“class III”) devices (such as pacemakers and insulin pumps) are subject to stringent premarket requirements including demonstration of clinical effectiveness, typically done through the Premarket Approval pathway. Medium-risk devices (such as glucose monitors and CT scanners) generally earn marketing clearance through the “510k” pathway, which assesses whether a given device raises new safety or effectiveness concerns compared with a currently-marketed device to which the technology being evaluated is deemed “substantially equivalent.”3
Kramer DB, Yeh RW. Practical Improvements for Medical Device Evaluation. JAMA. 2017;318(4):332–334. doi:10.1001/jama.2017.8976
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