Research Article: Characterization of US Food and Drug Administration Class I Recalls from to for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
Abstract:
The Food and Drug Administration (FDA) is responsible for monitoring the safety and effectiveness of medical devices in the United States. FDA categorizes medical devices into three classes, based on the extent of regulatory evaluation needed to provide “reasonable assurance of safety and effectiveness”. While the highest-risk (Class III) devices must undergo premarket approval (PMA), requiring clinical data demonstrating device safety and effectiveness, most moderate-risk (Class II) devices are cleared through the premarket notification (k) pathway based on substantial equivalence to a legally marketed predicate device, rarely with clinical data. With limited premarket clinical testing before FDA authorization, even among the highest-risk devices,, safety concerns are sometimes not identified until the post-market setting. Further, even when clinical data are available, rare adverse events or those that take time to develop may not be apparent at the time of FDA authorization.
Introduction:
The Food and Drug Administration (FDA) is responsible for monitoring the safety and effectiveness of medical devices in the United States. FDA categorizes medical devices into three classes, based on the extent of regulatory evaluation needed to provide “reasonable assurance of safety and effectiveness”. While the highest-risk (Class III) devices must undergo premarket approval (PMA), requiring clinical data demonstrating device safety and effectiveness, most moderate-risk (Class II) devices are cleared through…
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