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product
FDA PMA Process for Medical Devices
This product was added to our catalog on Tuesday 05 May, 2009.
Item #:
Price:  $395.00
  
Product description
60 Minute Webinar Recording

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


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
Cost
The cost to purchase the video recording is $395.

Once your order is processed you will shipped a copy of the video file on flash drive. The video comes in windows media format and can easily be played on your computer.
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