Knowledge base

Medical Devices

the FDA regulates the safety and effectiveness of medical devices, the packaging and labeling that describes how they should be used, and the facilities that manufacture them. FDA’s requirements for approving devices for marketing depend on the device’s potential for harming patients. Class I, or low-risk, devices include such things as elastic bandages and orthopedic saw blades. Class II or medium-risk devices, include items like urethral catheters and blood pressure cuffs. Class III, or the most stringent regulatory control for devices, such as heart valves and balloon angioplasty catheters, support or sustain human life and present significant risk of patient injury. Most Class I devices can be marketed without obtaining prior approval from FDA. FDA requires the manufacturers of most Class II and Class III devices to submit either a premarket notification application (510(k)) to show that the device is substantially equivalent to one already on the market or an application for premarket approval (PMA), which provides evidence, often including clinical data, demonstrating that the device is safe and effective. Qui Tam lawsuits have been successfully brought for off-label and kickback violations by the manufacturers of medical devices. Other scenarios include unapproved devices and clinical trial fraud.

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