FDA is responsible for oversight of medical devices sold in the United States. Regulations place devices into three classes, with class III including those with the greatest risk to patients. Unless exempt by regulation, new devices must clear FDA premarket review via either the 510(k) premarket notification process, which determines if a new device is substantially equivalent to another legally marketed device, or the more stringent premarket approval (PMA) process, which requires the manufacturer to supply evidence providing reasonable assurance that the device is safe and effective.
Medical devices are regulated by FDA’s Center for Devices and Radiological Health (CDRH). Examples range from simple tongue depressors and bedpans to complex programmable pacemakers with microchip technology and laser surgical devices. They are also subject to premarketing and postmarketing regulatory controls.
Research by Eliza Brannigan & Kristin Peters
