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Use of these materials is entirely at your own risk

A De Novo applicant that has accumulated substantial regulatory-grade data through clinical studies can argue to the FDAas part of the De Novo processthat special controls involving performance standards are needed to ensure the safety and effectiveness of devices in the same (newly-established) category, requiring comparable clinical studies to be conducted in all follow-on 510(k) submissions

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Zofran can also help with abdominal pain and diarrhea by reducing intestinal motility