Consumers are justifiably upset when their cars, toasters, and baby food bottles are recalled. Recalls make us all question the safety of the products we take for granted. But what about the products permanently implanted inside our bodies? Surely they have been sufficiently tested to ensure that no one will need to bring their thorax to the shop for removal and replacement. It is sad and troubling to learn that we cannot count on this assurance for some medical devices.
Medical devices are divided into 3 classes by the FDA, according to their level of risk to patients.1 Class I devices pose a low risk, present minimal potential harm to patients (items such as stethoscopes and bandages), and are subject to minimal regulation. Class II devices pose a moderate risk, include such items as hearing aids and wheelchairs, and may be cleared through the 510(k) premarket notification process, whereby they can be marketed if they are substantially equivalent to a predicate device. Importantly, clinical trials are not necessary for these 2 device classes.
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