Efficient and predictable regulatory processes are essential to fostering innovation and ensuring patients have timely access to safe and effective medical devices and diagnostics. AdvaMed’s Technology and Regulatory Affairs department works with the U.S. Food and Drug Administration to ensure that regulatory processes are reasonable and predictable and result in science-based decisions.
Safety, effectiveness, and quality are the watchwords of the medical device industry, and companies commit time and expertise to ensure that their devices perform properly and serve patient needs. This commitment starts at the earliest design phase and continues through the development, manufacturing, and distribution of a device.
After the FDA conducts its premarket review of a medical device, the manufacture and performance of the device are tightly controlled and monitored through a series of postmarket requirements. FDA’s postmarket requirements encompass every aspect of a device’s manufacture – from production and processing to packaging, distribution and use.