What Does PMAA Stand For?

PMAA stands for Premarket Approval Application

PMAA, or Premarket Approval Application, is a submission required by the U.S. Food and Drug Administration (FDA) for the approval of medical devices considered to pose a higher risk to patients. The PMAA process involves a thorough review of comprehensive evidence demonstrating the device's safety and effectiveness, including clinical trial data and manufacturing information, before it can be marketed and distributed. This regulatory pathway ensures that only devices meeting stringent safety standards reach the market, thereby protecting public health.