De Novo Submission
De Novo Submission allows FDA to establish new product classifications for low to moderate-risk medical devices that meet existing device classifications, thereby significantly easing the regulatory authorization pathway.
The program provides a means route for a new medical device to market. The eligibility for a de novo is based on several factors, such as FDA precedent, level of risk, and the ability to characterize and mitigate risks of the device.
The De Novo submission request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.
Devices that are categorized as class I or class II through a De Novo classification request (De Novo request) may be sold and, where appropriate, utilized predicates for upcoming premarket notification FDA 510k filings.
De Novo Submission Regulatory Pathway
The FDA has two alternatives for submitting a De Novo request for a risk-based assessment of the device’s categorization into class I or class II.
De Novo Classification Request
The applicant will be charged for De Novo requests. Please visit MDUFA User Fees to view the current user fee amounts. Prepare e- copy through e-star and send de novo submission through CDRH Customer Collaboration Portal.
- When your device is a novel medical device
- When your device is risk classified from low (Class I) to moderate (Class II) to which no suitable predicates are identified.
- Otherwise your device is risk classified as Class III
Content and Format of the 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 Submission Process and 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 review the submission and either grant or decline 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 acknowledgment 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 accepts 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,
Withdrawal of De Novo request
FDA considers withdrawing the de novo request based on two conditions, if:
- The submitter submits a written notice to FDA to withdraw the de novo request.
- The submitter failed to provide additional information response within 180 days, then the de novo submission will be withdrawn.
- The FDA aims to make a decision on a De Novo request within 150 review days.
- The number of review days is calculated as the number of calendar days between the date the FDA received the De Novo request and the date of the FDA’s decision, excluding the days a request was on hold for an Additional Information request.