device approval process

The device approval process involves evaluating a medical device to ensure it is safe and effective for use. Manufacturers submit detailed data, including testing results and manufacturing information, to regulatory agencies like the FDA. These agencies review the data to verify the device performs as intended and doesn't pose undue risks. If it passes review, it receives approval or clearance to be marketed and used in healthcare settings. This process helps protect patients by making sure medical devices meet established safety and quality standards before reaching the market.