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Recorded Webinar

What you need to know about FDA’s Premarket Requirements for Medical Devices

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

Do you know how to place your device on the market in the US? How your device is classified? What kind of premarket submission is required?

This webcast presents an overview of FDA regulation of medical devices – device classification, regulatory requirements for each class, premarket submission types, and when clinical testing is needed for a device submission.

The presentation will cover the following areas:

  • Device classification scheme
  • How to determine your device’s classification
  • The regulatory requirements for each class of medical device (General Controls, Special Controls)
  • Premarket Submissions (510(k), PMA and PDP, de novo)
  • When clinical testing is needed


**Watch for follow-on webcasts in the coming months that will cover each kind of premarket submission in more detail!


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