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Recorded Webinar

What you need to know about the CDRH’s Pre-submission Process

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

The pre-submission program (“pre-sub” or “Q-sub”) is an effective way to obtain feedback from CDRH prior to a submission and adds transparency to the submission process at CDRH. Having answers to your questions sooner rather than later – or rather than guessing at what CDRH wants to see – helps you to plan your studies and your submissions. You will learn what firms should know about CDRH’s presubmission program, how CDRH administers the pre-submission program, and best practices to effectively use the program.

The presentation will cover the following areas:

  • What the pre-submission process is – applicable laws, regulations, and guidance documents, definitions.
  • CDRH’s current thinking on the pre-sub process
  • When to use the pre-sub process
  • Pre-submission requirements
  • Dos and Don’ts for an effective pre-submission


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