On October 30, 2017 FDA published a new guidance that describes the process for the submission and review of a De Novo classification request for novel devices, that are automatically classified as Class III devices because they don’t have predicates. And allowing them to be down classified to Class I or Class II devices. A chart showing the new De Novo review process is provided here below.

According to this guidance, one of the following two mechanisms can be used to interact with FDA on this matter:

  • Pre-Submission (Pre-Sub)- Although the Pre-Sub is not required to obtain FDA review of a De Novo request, but it is a useful way to obtain early feedback from the agency on whether a device is eligible for the De Novo classification process, and get advise on the documentation needed for a subsequent De Novo request.
  • De Novo Request- A De Novo request may be submitted with or without a preceding 510(k). The success of a De Novo request that is filed without a Pre-Sub will depend more heavily on how well the search is done on predicate devices, and what scientific information was collected to support that request.

Let Global Regulatory Partners help you with your De Novo Classification with FDA

Preparing your De Novo request for classification is not an easy task, first of all you need to make sure that there are nor predicate devices on the market and then prepare the appropriate rational for FDA to justify your request for De Novo classification

Contact us today at info@globalregulatorypartners.com to find out how Global Regulatory Partners team can help you with your De Novo Device.

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