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Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.
The following sections should be included in your De Novo request:
Administrative information: intended use statement, prescription vs. over-the-counter use
Complete device description: technology, proposed conditions for use, accessories, components, etc.
Regulatory history
Change summary (if needed)
Device labeling
Classification information and supporting data: complete discussion of general controls and/or special controls; clinical data relevant for safety and effectiveness; nonclinical data and bench performance testing; information on reprocessing and sterilization, shelf life, biocompatibility, software, animal studies; description of probable benefits compared to anticipated risks
