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Recorded Webinar

FDA PMA Submissions - Contents, Process, Pitfalls

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

FDA requires a premarket approval (PMA) submission for Class III medical devices and is working its way through the list of preamendment devices to “call” for PMAs for those products. This webcast presents an overview of PMA submissions – when to submit, what options are available, contents of each PMA type, the PMA review process, and pitfalls to avoid with your submission.

The presentation will cover the following areas:

  • History of PMA regulations.
  • When to file a PMA.
  • Who must file a PMA .
  • Preamendments devices and PMA requirements.
  • Types of PMA submissions.
  • Contents of a PMA.
  • PMA review process.
  • PMA user fees, review times, review trends
  • Pitfalls and common mistakes
  • Resources for more information


Apply for this webinar

Who should attend

Anyone who is interested in learning more on FDA Regulations

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