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The De Novo application process follows a draft guidance document: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM273903.pdf.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 The draft guidance identifies one unique section to a De Novo application: the cover letter (i.e., Attachment II in the De Novo guidance).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:
http://medicaldeviceacademy.com/blog/

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On Thursday, January 28th I’m sharing my own tips and templates for De Novo applications. Visit the following webpage in order to register for the webinar: http://medicaldeviceacademy.com/de-novo-application-webinar/.

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Medical device manufacturers are unaware about packaging, waste electrical and electronic equipment (WEEE), and battery recycling regulations. Manufacturers should be paying an EPR fee in order to ensure they are compliant with the environmental recycling requirements for Europe, Asia/Pacific and North America. If you want to learn more about the topic, you can attend the http://medgroup.biz/learn-EPR webinar for free.

source: https://www.linkedin.com/groups/2070960/2070960-6095554037317451778