This is one of the regulatory pathways of premarket submission that can be made to the FDA to market a device. This method can be used for novel devices whose type has not been previously classified, and low to medium-risk medical devices. There are two options for de novo request:
· When the device first submitted to 510(k) submission but resulted in Not substantially equivalent
· When the device doesn’t have any predicate device, can directly submit under the de novo pathway
The device marketed from the de novo pathway can be used as a predicate device for future proposed devices. If the de novo request is declined, then the device remains in class III and may not be marketed until it finds any substantial equivalence device.
Contents of De novo Request
The De novo submission document is the same as the traditional and abbreviated 510(k) submission, but some contents are not required in the de novo document.
· Section 5: 510k Summary or 510k Statement is not required, because this is not a 510k submission
· Section 12: Substantial Equivalence Comparison, because a De Novo does not claim equivalence to a predicate.
De Novo review timeline
The de novo is the same as 510(k) submission, the electronic copy of the technical file is converted to DVD, and CD and the file should in PDF format. The FDA receives and reviews the submission and either grants or declines the submission.
On day 1, the FDA receives the submission and assigns the submission number, the number begins with “DEN” followed by a six-digit. This will be included in the acknowledgement letter which will be provided to the submitter.
On day 15, the FDA conducts an acceptance review, where to check if it meets all the acceptability. If the document is not accepted, then it will be put on RTA hold and when the mission information is received FDA will accept it for substantive review.
On day 60, the FDA conducts a substantive review of whether any marketed device of the same type exists during this review the FDA may identify deficiencies that can be addressed in the interactive review. These deficiencies are mentioned in the additional information request letter that will be sent to the requester. The submitter has to solve the issue within 180 days and respond to the FDA. If failed to respond, the submission will be deleted
The final action of De Novo’s request
The FDA makes a final decision of either grant or decline,
Grant:
The device can be marketed and can be used as a predicate device for 510(k) future submission device
Decline:
The data provided in the request may be insufficient to determine the risk of the device then the device remains in class III and cannot be legally market the device
A De Novo submission to the FDA can be declined for various reasons. Here are some common reasons:
- The submission lacks the necessary clinical data, incomplete testing results, or insufficient evidence to support claims.
- The submission does not meet labelling, manufacturing processes, or quality control measures.
- FDA finds that the device is not sufficiently different from existing devices or fails to demonstrate its novel status
- The submission does not adequately address potential risks
- The performance testing provided in the submission does not adequately demonstrate that the device performs as intended.
- The intended use or indications for the device are not clearly defined
- The bench testing data-related design, methodology, or interpretation of the test results is not correct
- The device’s usability is difficult to use safely and effectively.
- The device might be better suited for a different regulatory pathway, such as a 510(k) or PMA.
- Errors in the submission process, such as missing documents, incorrect formatting
Withdrawal of De Novo request
FDA considering withdrawing the de novo request based on two conditions, if:
· The submitter submits a written notice to the FDA to withdraw the de novo request
· The submitter fails to provide additional information response within 180 days, then the submission will be withdrawn.