WHILE THE DIZZYING ARRAY of FDA regulations and changes may seem overwhelming, there is a checklist that can help you stay sane and in compliance.Medical device manufacturers are regulated in two different but related ways by the FDA. First as with drugs, device manufacturers must convince the FDA through a pre-market notification process that their devices are both safe and effective. However, the FDA also requires medical device manufacturers to comply with its Quality System Regulations (QSRs). This set of regulations controls the methodologies and processes used by a manufacturer to design, develop, manufacture, and maintain their devices. This second set of controls is intended to assure the quality and consistency of the development and manufacturing processes by requiring a formal, systematic quality system to further assure the safety of the device.
