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De Novo provides a way for a new device, without a valid predicate, to be classified into Class I or II if it meets certain criteria. The FDA reviews De Novo petitions for new devices that meet two threshold criteria: 1. the new device is not within a device type that has been classified based on risk; and 2. the new device is statutorily classified into Class III and FDA has provided “written notice” of this, such as a “not substantially equivalent” determination in response to a premarket notification (510(k)) submission, within the last 30 days.

Pragmatic can help you with the preparation of your De Novo submission. Please contact us for more information.

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