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Recorded Webinar

What you need to know about FDA's de novo 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 de novo process is relatively new, and is not well understood by industry. It has also changed significantly in the last couple of years. You will learn what firms should know about the de novo process, how CDRH administers the de novo process, and best practices to ensure an effective “de novo request for classification” submission that will result in CDRH granting the de novo request for your new device.

The presentation will cover the following areas:

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


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