Abbreviated PMA

Abbreviated PMA, or Premarket Approval, is a process used by the U.S. Food and Drug Administration (FDA) to evaluate and approve medical devices before they are marketed. It ensures that new medical devices are safe and effective for use. Manufacturers submit detailed data and studies demonstrating the device’s safety and performance. The FDA reviews this information thoroughly. If the device meets all requirements, the FDA grants the PMA, allowing the device to be legally sold and used. This process is mostly required for high-risk devices, while lower-risk devices often undergo a less rigorous review.