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FDA Medical Device, De Novo Process Guide

Sep 09 2022


The new device which is a low to medium risk on the market requires a pathway of the De Novo process.


The De Novo 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. De Novo classification is a risk-based classification process.

Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, when applicable.



When and How to prepare a De Novo request :


  • After receiving a high-level not substantially equivalent determination which is no predicate, new intended use, or different technological characteristics that raise different questions of safety and effectiveness in response to a 510(k) submission.

  • Upon the requester’s determination that there is no legally marketed device upon which to base a determination of substantial equivalence.


For your successfully pass the FDA De Novo process, you may need to follow 3 steps:



Step 1. Understanding of FDA’s review process and timeline


Upon receipt of a De Novo request, the FDA will conduct an acceptance review. The acceptance review is an administrative review to assess the completeness of the application and whether it meets the minimum threshold of acceptability. If any of the acceptance elements are not included, there should be a justification for the omission.



Within 15 calendar days of the DCC receiving the De Novo request, the FDA will notify the requester electronically of the acceptance review result as one of the following:

  • the De Novo request has been accepted for substantive review;

  • the De Novo request has not been accepted for review (that is, considered refused to accept or RTA) and the requester has 180 calendar days to fully address the RTA notification; or

  • the De Novo request is under substantive review and the FDA did not complete the acceptance review within 15 calendar days.


The De Novo request will not be accepted and will receive a Refuse to Accept (RTA) designation if one or more of the elements noted as RTA items in the Acceptance Checklist are not present and no explanation is provided for the omission(s). However, during the RTA review, the FDA staff has discretion to determine whether missing checklist elements are needed to ensure the De Novo request is administratively complete to allow the De Novo request to be accepted.



Step 2. Understanding and be paid all fees include MDUFA User Fee


All establishments must pay the establishment registration fee, FDA user fees including De Novo. There are no waivers or reductions for small establishments, businesses, or groups.


User Fees for FY 2022


The fiscal year begins in October 1, 2021 through September 30, 2022 and increased each year.



Step 3. Research all the necessary for your submission


FDA requires you to prove that your device is not substantially equivalent to any similar device already on the market. For proof, you need to research all the necessary for your submission including the market if there is a predicate device existing or not.


You can review on the U.S FDA Device classification database and Device Classification under section 513(f)(2) (De Novo)




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