Medical device (De Novo)


Wise Company Inc. provides consulting service on De Novo clearance procedure based on years of accumulated FDA and CE regulatory experience and data.
  It is a marketing authorization process for novel medical devices where the risk level corresponds to Class I or Class II. These devices either lack a predicate device (FDA-cleared medical device) or differ from predicate devices in terms of intended use or mechanism of action. This process involves establishing a method to demonstrate safety and effectiveness based on the intended use, controlling anticipated risks, and creating a new product code.

The De Novo procedure can be applied in the following two cases:
  • (1) After submitting a 510(k), if the device is determined to have no predicate device or is deemed NSE (Not Substantially Equivalent) due to new intended use or new technology.
  • (2) When the applicant determines that the device under review is appropriate for Class I or Class II classification but concludes that there is no similar product code or predicate device.
2. De Novo Procedure and Required Documentation 2-1. Pre-submission
      When proceeding directly with the De Novo process without a 510(k) submission (Direct De Novo), a pre-submission is recommended. This allows for obtaining FDA feedback on whether the product is suitable for the De Novo process, whether the review materials sufficiently demonstrate safety and effectiveness, and whether the established regulatory controls are appropriate. Through this, the applicant can confirm if preparations for the De Novo process are progressing appropriately from the product development stage.
2-2. Submission of Application and Acceptance Review)
      For the substantive review, the FDA checks whether the necessary documents and related materials are complete (approximately 15 days). If additional information or documents are required, an RTA (Refuse to Accept) letter is issued, requesting the submission of supplemental materials within 180 days.
2-3. Classification Review
      Once the submission materials for substantive review are ready, the FDA will assess whether a predicate device exists, whether the device falls under Class III, or whether a similar product is already undergoing the PMA process. If any of these conditions apply, the De Novo classification request will be denied and terminated.
      Therefore, it is crucial to thoroughly prepare materials proving that the product in question is a novel device that has not been previously classified. This preparation is especially important in the case of Direct De Novo, where no prior feedback from the FDA regarding previous classifications is available.
2-4. Substantive Review
      If the device meets the criteria for De Novo Classification, the FDA proceeds with a substantive review, during which all submitted materials are thoroughly examined to identify any deficiencies. Requests for additional information may be made through an Interactive Review or an Additional Information letter. Deficiencies outlined in the Additional Information letter must be resolved, and supporting evidence must be submitted within 180 days.
      The FDA may request an inspection of the facility for the following reasons:
    • (1) To assess whether clinical and non-clinical data collected during the De Novo process are reliable.
    • (2) To verify whether the device is being manufactured safely and effectively.
    • (3) To determine if the manufacturer’s Quality Management System complies with QSR (21 CFR Part 820).
2-5. Notification of Review Results   The FDA notifies the applicant whether the De Novo request has been approved (Grant) or denied (Decline).
    1) If Approved
    • – A new product code is established, and, if classified as Class II, the applicable special controls are defined.
    • – Within 30 days of approval, the classification of the device and applicable requirements are codified and publicly announced.
    2)If Denied
    • – The De Novo request is denied with an explanation of the reasons, and the process is terminated.
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