Premarket Clinical Evidence Strength and Recalls of High-Risk Therapeutic Medical Devices

In this cross-sectional study, more than one-third of high-risk therapeutic medical devices were subject to serious recalls. Because device, premarket clinical evidence, and regulatory characteristics were not consistently associated with serious recalls, robust postmarket surveillance is needed to ensure patient safety.

Corresponding Author: Maryam Mooghali, MD, MSc, Department of Internal Medicine, Yale School of Medicine, 330 Cedar St, New Haven, CT 06510 (maryam.mooghali@yale.edu).

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