Premarket review process for some medical devices raises safety concerns
Before a medical device can be marketed and sold in the United States, the Food and Drug Administration (FDA) must review the device and make a determination about its safety and effectiveness. Once the FDA is satisfied with the safety and effectiveness of a medical device, it will clear the device for marketing to the public. Unfortunately, in an attempt to obtain speedy clearance to market from the FDA, some manufactures misrepresent the characteristics and/or intended uses of devices resulting in the sale and use of unsafe and ineffective medical devices, often resulting ...





