FDA De Novo Medical Devices

Medical DevicesFDA De Novo Medical Devices

De Novo is a pathway for classifying new medical devices that provide reasonable assurance of safety and effectiveness for their intended use through general controls, or general and special controls, but for which there are no legally marketed devices available on the market. Therefore, the De Novo classification is a risk-based classification process.

Devices classified as Class I or Class II through a De Novo classification request can be marketed and used as the initial reference for future Premarket Notification (510(k)) submissions.

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Medical DevicesSubmitting a De Novo application to the U.S. FDA.

Submitting a De Novo application to the U.S. FDA for a risk-based evaluation to classify the device as Class I or Class II.

Option 1: Upon receiving a high-level non-substantial equivalence (NSE) determination for the 510(k) submission.

Option 2: Determined by the applicant when there are no legally marketed equivalent devices available on the market to serve as a basis for determining substantial equivalence.

Before submitting a De Novo application to the FDA, we assist in preparing and submitting the necessary documentation to the premarket review department and obtaining feedback.

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Data Organization and AnalysisTesting Data Required for Medical Device Applications

Collaborate with global partners to provide technical documentation compliant with ISO, GLP, and FDA regulations, including the testing data required for medical device submissions. Utilize known data to establish a complete data chain for regulatory authorities, ensuring that medical device data is clear and controllable for submission to regulatory agencies.

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Medical DevicesFDA's Substantial Review of De Novo.

FDA Medical Device Interactive Question-and-Answer Review.

The FDA conducts a classification review of legally marketed device types to analyze whether there are existing legally marketed devices of the same type. This information is used to confirm whether your device meets the criteria for De Novo classification.

After the classification review is completed, the FDA will begin the substantive review of the De Novo request. During this process, the lead reviewer may resolve any identified deficiencies through interactive review, without the need for a formal request for additional information.

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