Medical Devices

Evaluation of Automatic Class III Designation (De Novo)

Please note: Starting October 1, 2017, FDA charges a fee for review of De Novo Classification Requests.


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 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 sponsor 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 (i.e., new intended use and/or different technological characteristics that raise different questions of safety and effectiveness) in response to a 510(k) submission.
  • Option 2: Upon the sponsor’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, it is recommended that you consider submitting a pre-submission (pre-sub) to obtain feedback from the appropriate premarket review division.

The following information should be included in a De Novo request:

  • A coversheet clearly identifying the request as a “Request for Evaluation of Automatic Class III Designation” under 513(f)(2) or De Novo request.
  • The 510(k) submission number under which the device was found NSE (if applicable). A statement of cross reference to the information contained in a 510(k) submission (if applicable).
  • The classification being recommended under section 513 of the Food, Drug and Cosmetic Act (FD&C Act).
  • A discussion of the probable benefits of the device when compared to the probable or anticipated risks when the device is used as intended.
  • A complete discussion of the proposed general and/or special controls to ensure reasonable assurance of the safety and effectiveness of the device, and what special controls, if proposing a class II designation, would allow the Agency to conclude there is reasonable assurance the device is safe and effective for its intended use.
  • Any clinical and/or nonclinical data that are relevant to ensure reasonable assurance of the safety and effectiveness of the device.
  • For further information, please reference the guidance document De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff.
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 applicant.

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

We recommend submitting a De Novo request to FDA by a method that will provide a signed receipt of delivery, e.g., 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.

FDA Review and Review Timeline
  1. First, when the FDA receives a De Novo request, the FDA will verify that another submission for the same device (same technology characteristics and same indication(s) for use) from the same requester is not under review (e.g., Pre-Sub, 510(k) or PMA).
  2. Second, the FDA will determine if all the content required by Section 513(f)(2) of the FD & C Act is provided. The applicant should include a determination that there is no legally marketed device upon which to base a determination of substantial equivalence. A De Novo request that lacks the information to make this determination may be placed on hold.
  3. Next, the FDA will conduct a classification review of legally marketed device types and analyze whether an existing legally marketed device of the same type exists. This information is used to confirm that your device is eligible for De Novo classification.
  4. 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 (i.e., Additional Information (AI) letter).

    If the issues/deficiencies cannot be addressed through interactive review, an Additional information (AI) letter will be sent to the applicant. If an AI letter is sent, then the submission is placed on hold. The submitter has 180 calendar days from the date of the AI letter to submit a complete response to each item in the AI letter.

    Note: The response must be received in the DCC within 180 calendar days of the date of the AI letter. No extensions beyond 180 days will be granted. If the FDA does not receive a complete response to all deficiencies in the AI letter within 180 days of the date of the AI letter, the submission will be considered withdrawn and deleted from our review system. If the De Novo request is deleted, the De Novo applicant will need to submit a new application to pursue FDA marketing authorization for that device.

    The applicant must submit their response to an AI letter in electronic format (eCopy), to the DCC of the appropriate Center. The response should:
    • include the submitter’s name;
    • identify the De Novo number;
    • identify the submission as a response to the AI letter;
    • identify the date of FDA's request for additional information; and
    • provide the requested information in an organized manner.
  5. The final step is the De Novo request decision. Under MDUFA IV, the FDA goal is to make a decision about a De Novo request in 150 FDA review days. FDA review days are calculated as the number of calendar days between the date the De Novo request was received and the date of decision, excluding the days a submission was on hold for an AI request.

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

De Novo Classification Process (Evaluation of Automatic Class III Designation) - Guidance for Industry and Food and Drug Administration Staff

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals – Guidance for Industry and Food and Drug Administration Staff

Acceptance Review for De Novo Classification Requests; Draft Guidance for Industry and Food and Drug Administration Staff (this guidance is not final and is not for implementation at this time)

Guidance for Industry and Food and Drug Administration Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (PDF - 1.1MB)

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 a De Novo request is granted:

• the new device is legally 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;

• FDA publishes in the Federal Register a notice that announces the new classification regulation and, for class II devices, the new special controls;

• FDA posts on its website a copy of the granting order notifying the sponsor that we have granted marketing authorization; and

• FDA generates and publically discloses a decision summary.

Beginning in 2010, the FDA publishes 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 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 publically 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

FDA will decline a De Novo request if it determines 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 applicant may not legally market the device. FDA will issue a written order to the requestor identifying the reasons, including lack of performance data, which warrant declining the De Novo request. The applicant may either submit an application for premarket approval (PMA) 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.

Frequently Asked Questions (FAQs)
  1. Do I have to obtain a 510(k) NSE decision before submitting a De Novo request? No, you do not need to receive an NSE decision for a 510(k) before you submit a De Novo request.
  2. Are De Novo requests eligible for a reduced small business fee? Yes, there is a reduced user fee for small businesses for De Novo requests. You must obtain your small business determination before you submit your De Novo request to be eligible for the reduced user fee. Please refer to the Medical Device User Fees webpage for more information on how to obtain a small business determination.
  3. Is there a waiver for my first De Novo request? No, there is no first application submission fee waiver for De Novo requests. 

 

Page Last Updated: 02/15/2018
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