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Medical devices play a critical role in the lives and health of millions of people worldwide. From everyday household items such as oral thermometers to complex implantables such as deep-brain stimulators, patients and the general public rely on regulators to ensure that legally marketed medical devices have been shown to be safe and effective. Regulators expect data that are provided by device manufacturers to reflect the risk profile of the device. For example, a device that most consumers can use without instruction, such as reading glasses or elastic bandages, will require a very different evidence profile than a device, such a portable ventilator, on which a patient’s life could depend.
Although devices are manufactured and marketed worldwide, this review focuses on the strategy used by the U.S. Food and Drug Administration (FDA); special attention is paid to the ways in which the evaluation of devices is distinct from that of drugs. The entry of the FDA into the device arena was largely prompted by several deaths and claims by an estimated 200,000 women that they were harmed by the use of the Dalkon Shield, an intrauterine device (IUD) intended for contraception. Women who used this device had five times the risk of pelvic inflammatory disease as those using other IUD types, and several had uterine rupture or septic pregnancies. Congress responded by passing the Medical Device Amendments to the Food, Drug, and Cosmetic Act.1,2 These 1976 amendments established a risk-based regulatory framework for evaluating medical devices in the United States. Under this framework, the requirements that a device must meet to be lawfully marketed depend on the risk classification of the product, with risk being assessed as the potential for the device to present harm to the patient, including in circumstances in which the device could malfunction or be used improperly.
Most low-risk devices, which present a minimal potential for harm to the user (e.g., prescription eyeglasses, elastic bandages, and dental floss), are exempt from FDA review before marketing, although manufacturers are still subject to certain requirements. Manufacturers of most moderate-risk devices, such as condoms, nebulizers, and blood glucose meters, generally need to show that their device is substantially equivalent to another device already cleared by the FDA; in most cases, this...