Ensuring Safety Throughout Development
Before any device reaches the market, it is rigorously evaluated for safety and effectiveness. Companies devote enormous time and resources to developing and improving technologies, and FDA subjects thousands of devices to extensive science-based reviews every year.
Because medical devices vary in complexity, technological characteristics and patient impact, FDA has developed a risk based premarket review system that determines the level of evidence and review based on the device type.
Continued Safety in the Field
Ensuring safety, effectiveness and quality doesn’t stop once a device is cleared or approved. Companies must monitor and control every facet of production and distribution of their products, gathering feedback on their manufacturing processes and the products themselves. This data is used to make improvements to the device and to develop new devices.
FDA's requirements for adverse event reporting and product recalls complement manufacturers’ postmarket oversight. These requirements help provide continued safeguards for patients long after a medical technology is on the market.