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  1. Premarket Submissions

De Novo Classification Request

On December 7, 2018, the FDA published a proposed rule to establish regulations for the De Novo classification process. The De Novo process was added to the statute in 1997 under the Food and Drug Administration Modernization Act (FDAMA) and has been modified as part of the FDA Safety Innovation Act and the 21st Century Cures Act; however, currently no regulations exist for this program. The proposed regulations, if finalized, are intended to provide structure, clarity and transparency on the De Novo classification process, including requirements related to the format and content of De Novo requests, as well as processes and criteria for accepting, granting, declining and withdrawing De Novo requests. Please refer to docket FDA-2018-N-0236 for the proposed rule and comments received.

What is a De Novo Classification Request?

The De Novo process provides a 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.

How to Prepare a De Novo Request

There are two options for when a requester can submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into class I or II.

  • Option 1: After receiving a high-level not substantially equivalent (NSE) determination (that 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.
  • Option 2: Upon the requester's determination that there is no legally marketed device upon which to base a determination of substantial equivalence (therefore without first submitting a 510(k) and receiving a high-level NSE determination).

Prior to submitting a De Novo request to the FDA, we recommend you consider submitting a pre-submission to obtain feedback from the appropriate premarket review division.

For further information, please reference the guidance documents: De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff and Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.

Content of the DeNovo Request

A De Novo request should include all the content elements necessary for acceptance of the De Novo request, listed in Appendix A of the "Acceptance Review for De Novo Classification Request" guidance document. The FDA intends to Refuse to Accept a De Novo request that does not include these elements. Pertinent elements of a De Novo request are reiterated below:

  • A coversheet clearly identifying the request as a "Request for Evaluation of Automatic Class III Designation" under 513(f)(2) De Novo request.
  • Administrative Information, such as the device's intended use, prescription use or over-the-counter use designated, etc.
  • Device Description, including technology, proposed conditions of use, accessory, components, etc.
  • Classification Information and Supporting Data:

Although not required, requesters should also consider including the recommended elements in Appendix B of the guidance (as applicable). Doing so may decrease the number of questions posed by the FDA during the substantive review of a De Novo request.

For further information on the De Novo request content, please reference the guidance documents "De Novo Classification Process (Evaluation of Automatic Class III Designation)"  and "Acceptance Review for De Novo Classification Requests."

How to Submit a De Novo Request

De Novo requests must be submitted in an electronic format (eCopy). Once a De Novo request is received by the FDA, we do NOT return the submission or any copies to the requester.

Requests should be sent to the appropriate Document Control Center (DCC). The current mailing address for CDRH's Document Control Center and a link to the Center for Biologics Evaluation and Research's (CBER) Document Control Center's mailing address are provided on the eCopy Program for Medical Device Submissions webpage.

We recommend submitting a De Novo request to the FDA by a method that will provide a signed receipt of delivery, for example, registered mail with a return receipt or a commercial delivery service. When CDRH or CBER receives a De Novo request, the appropriate Center assigns the request a unique document number. The De Novo number begins with "DEN" followed by six digits. The first two digits represent the calendar year in which the request was received, and the last four digits represent the sequential request number for that year. For example, the first De Novo request received in the calendar year 2017 would be DEN170001. The appropriate Center will provide an acknowledgment letter, including the De Novo number, usually within 7 days of receipt of the De Novo request.

For assistance with De Novo requests submitted to the Center for Biologics Evaluation and Research (CBER), please contact 1-800-835-4709 or Industry.Biologics@fda.hhs.gov.

What Are the De Novo Request MDUFA User Fees?

De Novo requests are subject to user fees. For the current user fee amounts, please see MDUFA User Fees.

Additional information about medical device user fees and the small business qualification program can be found on the Medical Device User Fees and Reduced Medical Device User Fees: Small Business Determination (SBD) Program webpages.

FDA Review and Review Timeline

Acceptance Review:

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.

To aid in the acceptance review, we recommend requesters complete and submit Acceptance Checklists (see the guidance document) with their De Novo requests that identify the location of supporting information for each checklist element.

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.

Within 15 calendar days of the Document Control Center (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 (i.e., considered refused to accept or RTA) and the requester has 180 calendar days to fully address the RTA notification.
  • the De Novo request is under substantive review and the FDA did not complete the acceptance review within 15 calendar days.

Substantive Review

First, the FDA conducts a classification review of legally marketed device types and analyzes whether an existing legally marketed device of the same type exists. This information is used to confirm your device is eligible for De Novo classification.

After the classification review is complete, the FDA will begin the substantive review of the De Novo request. During the substantive review of a De Novo request, the Lead Reviewer may identify deficiencies that can be adequately addressed through interactive review and not require a formal request for additional information (Additional Information letter).

If the issues and deficiencies cannot be addressed through interactive review, an Additional Information letter will be sent to the requester. If an Additional Information letter is sent, then the De Novo request will be placed on hold. The requester has 180 calendar days from the date of the Additional Information letter to submit a complete response to each item in the Additional Information letter.

Note: The response must be received by the Document Control Center (DCC) within 180 calendar days of the date of the Additional Information letter. No extensions beyond 180 days will be granted. If the FDA does not receive a complete response to all deficiencies in the Additional Information letter within 180 days of the date of the Additional Information letter, the request will be considered withdrawn and deleted from the FDA's review system. If the De Novo request is deleted, the De Novo requester will need to submit a new request to pursue the FDA's marketing authorization for that device.

The requester must submit their response to an Additional Information letter in electronic format (eCopy), to the Document Control Center (DCC) of the appropriate Center. The response should:

  • include the requester's name;
  • identify the De Novo number;
  • identify the submission as a response to the Additional Information letter;
  • identify the date of the FDA's request for additional information; and
  • provide the requested information in an organized manner.

The final step is the De Novo request decision. Under MDUFA IV, the FDA's goal is to make a decision about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of the FDA's decision, excluding the days a request was on hold for an Additional Information request.

For further information on the review process, please reference the following guidance documents:

De Novo Request Decisions

The FDA may either grant or decline a De Novo request.

Grant

If your data and information demonstrate that general controls or general and special controls are adequate to provide reasonable assurance of safety and effectiveness, and the probable benefits of the device outweigh the probable risks, then the FDA intends to grant the De Novo request and establish a new classification regulation for a new device type.

If the FDA grants a De Novo request:

  • The new device is authorized to be marketed and must be in compliance with applicable regulatory controls;
  • A new classification regulation is established;
  • The new device may now serve as a predicate device for 510(k) submissions of future devices of the same type;
  • The FDA publishes in the Federal Register a notice that announces the new classification regulation and, for class II devices, the new special controls;
  • The FDA posts on its website a copy of the granting order notifying the requester we have granted marketing authorization; and
  • The FDA generates and publicly discloses a decision summary.

Beginning in 2010, the FDA has published decision summary documents for devices classified through the De Novo process. The De Novo decision summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the FDA's decision to grant a De Novo request. The De Novo decision summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate.

This information is publicly available in the De Novo Classification Requests database and also published on the CDRH Transparency website Evaluation of Automatic Class III Designation (De Novo) Summaries.

Decline

The FDA will decline a De Novo request if we determine that:

  • General controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device; or
  • The data provided in the De Novo request are insufficient to determine whether general controls or general and special controls can provide a reasonable assurance of safety and effectiveness of the device; or
  • The probable benefits of the device do not outweigh the probable risks.

If the De Novo request is declined, the device remains in class III and the requester may not legally market the device. The FDA will issue a written order to the requestor identifying the reasons, which can include lack of performance data that warrant declining the De Novo request. The requester generally should either submit an application for premarket approval under section 515 of the FD&C Act or collect additional information to address the issues and submit a new De Novo request that includes the additional information.

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