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FDA PMA Process for Medical Devices



 
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Product Code: WB4
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About the Product
Contains video file.

Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. PMA is the most compelling type of device marketing application required by the FDA. This webinar discussed the PMA process in detail from an FDA perspective.
  • When to submit a PMA
  • Key factors to consider when submitting a PMA
  • Review process
  • Case studies

Speaker
:
Nicole Wolanski, CDR, USPHS
Director, PMA Program, Office of Device Evaluation/Center for Devices and Radiological Health
FDA

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