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Companies developing devices with truly innovative technologies frequently have difficulty identifying suitable predicate devices. The best regulatory experts plan in advance for these regulatory submissions by honing their knowledge of the De Novo application process. If your design team is developing an innovative technology, you may have difficulty finding a predicate device that is substantially equivalent to your device.
If you have not completed a De Novo application before, where do you start?
The De Novo application process follows a draft guidance document: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM273903.pdf.
Pre-sub meetings are generally recommended by the FDA for manufacturers that intend to submit a De Novo application without a prior 510k submission and subsequent NSE letter. A pre-sub meeting allows the manufacturer to request input from the FDA regarding performance testing and special controls if the device is a Class II. The draft De Novo guidance document specifically recommends following the existing content guidelines for a pre-sub meeting request, but the guidance also recommends which elements to include with your pre-sub meeting request.
Twenty sections comprise a 510k submission, but regulatory experts typically use templates for each section in order to streamline the process of preparing a new device submission. For a De Novo application, a large percentage of the sections required for a 510k submission are the same. The draft guidance identifies one unique section to a De Novo application: the cover letter (i.e., Attachment II in the De Novo guidance). However, there are also three sections of a 510k submission that also need to be eliminated for a De Novo application.
Read more by reading my blog posting later today:
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Arthur Brandwood HI Rob, The presub process is really the key to a smooth ride on de novo. We have just filed a denovo for a very new diagnostic technology. Prior to that we went through three rounds of presub discussions with FDA which were detailed, thoughtful, and enormously helpful and resulted in a very clear picture of how to do the lab and clinical validation work and precisely what was required in the submission. This was far more helpful than any written guidance ever could be. Now we are straight in to substantive review - and that's being done by reviewers who were in the thick of the presub discussions and are already very familiar with the device and with the protocols used for its validation.
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Rob Packard Thank you for the comment Arthur. Yes, I recommend the pre-sub meetings to all my clients. However, the pre-sub meetings lose their value once you complete your performance testing. If testing is completed, you might as well go ahead with a submission, because the delay to wait for a pre-sub meeting is about as long as it takes to get feedback directly from a reviewer.
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