What is De Novo?
The De Novo classification request provides a pathway to classify novel devices (class I or class II) for which general and/or special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.
A predicate must have the same or similar intended use and technological characteristics that do not raise different questions regarding safety and effectiveness. The process has been termed “De Novo” because it requires the agency to evaluate novel devices anew.
There are 2 options to submit a DeNovo request:
- After receiving a not substantially equivalent (NSE) determination was received in response to a 510(k) submission.
- Upon the requestor’s determination that there is no legally marketed predicate device.
De Novo request:
When it is determined there is no legally marketed predicate device, a direct De Novo request can be made without a preceding 510(k) submission and “Not substantially equivalent” determination. The success of a De Novo request that is filed without a preceding 510(k) or without a Pre-Submission will depend more on how comprehensive a search was conducted for a potential predicate device, clear identification of health risks and special controls (if applicable), and adequate valid scientific evidence to support granting the De Novo request. A Pre-Submission related to a future anticipated De Novo request should contain sufficient information to provide guidance on the test methods and protocols that should be used for the collection of non-clinical and/or clinical data.
De Novo Approval:
If the De Novo request is granted, the new device is authorized to be marketed and must comply with applicable regulatory controls. A new classification regulation for the device type is established and permits the device to serve as a predicate device for future 510(k) submissions. For class II devices, special controls will also be identified.
If the De Novo request is declined, the device remains in class III and the requester may not legally market the device. The requestor will need to submit a new request to pursue marketing authorization for the device.
De Novo Withdrawal:
The FDA considers a De Novo request withdrawn if the requester submits written notice to withdraw, if Additional Information responses or deficiencies are not addressed within 180 calendar days after the date of the request or if the requester does not permit FDA facility inspection and access to records.
Fang Consultants can assist with predicate device searches to support 510(k) submissions or if needed, a De Novo Request.
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