PMA (Premarket Approval)

Premarket Approval (PMA) is the FDA's process for thoroughly reviewing and evaluating new medical devices or products to ensure they are safe and effective before they can be marketed in the United States. It involves detailed scientific and engineering data submission from the manufacturer, including clinical studies if needed. The FDA carefully reviews this information to make an informed decision, which helps protect public health by ensuring only safe, reliable devices reach consumers. PMA is typically required for high-risk devices, such as implantable pacemakers or certain diagnostic tools.