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FDA PMA Application - Medical Devices

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A Premarket Approval (PMA) is an application made to FDA to obtain marketing clearance. It is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Service

  • Organizing and reviewing the original materials and product information
  • Organizing and reviewing manufacturing process and control materials
  • Preparing PMA package
  • Submitting PMA materials to FDA
  • Correspondence with FDA
  • Routine maintenance of approved PMA (Annual report, change report, and notification…)

Link to "Services" for more information.