FDA (Food and Drug Administration) regulations on digital health

The FDA regulates digital health tools—such as mobile health apps, wearable devices, and software that monitor or manage health—to ensure they are safe and effective. They classify these tools based on risk and require manufacturers to demonstrate that their products work as intended before they can be marketed. The regulations aim to protect consumers from unsafe or ineffective digital health solutions while encouraging innovation. The FDA’s approach balances fostering new technologies with patient safety, often providing guidance or clearance processes to help developers bring reliable digital health products to the market.