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Recorded Webinar

FDA’s ‘Refuse to Accept’ Process for 510(k)s

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

This one-hour webinar will explain FDA’s “Refuse to Accept” (RTA) Process for 510(k) submissions – what it is, how it works, and what YOU need to know to have your 510(k) submission successfully complete the Refuse to Accept process at CDRH, so that it can progress to substantive review. Hear the latest statistics for the RTA process, too – how many submissions “pass” and how many are put on “RTA Hold”. Also learn what to do if your submission is put on RTA Hold.

The presentation will cover the following areas:

  • The RTA Process for 510(k) Submissions
  • How to address the RTA review “up front” BEFORE you file your 510(k)
  • How to address an “RTA Hold”
  • RTA Process Statistics


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