device approval

Device approval is the process through which a medical device is evaluated and authorized by a regulatory authority, such as the FDA, to ensure it is safe and effective for use. Manufacturers submit detailed information about the device’s design, manufacturing, and testing. The agency reviews this data to assess risks, benefits, and compliance with quality standards. Once approved, the device can be marketed and used in healthcare. This process helps protect patients by confirming that the device meets necessary safety and performance criteria before reaching the market.