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The de novo is a device classification process which allows the US FDA to classify new devices that are not equivalent to the existing Class I or Class II devices. These devices would otherwise be automatically classified as Class III devices [Section 513(f)(1) of the FD&C(Food, Drug and Cosmetic Act)], regardless of the risks associated with the device or the ability to demonstrate general or special controls. For devices that would be considered between low to moderate risk, and for which no substantially equivalent device is available, the de novo classification may be a suitable option for companies who wish to market their devices without submitting a 510(k) application.

How has the De Novo Classification Process Evolved?

The de novo classification process was established in 1997 following modifications to the FD&C Act under the FDA Modernization Act (also referred to as FDAMA) incorporating Section 513(f)(2) of the FD&C Act. The new section of the act allows companies to submit a de novo request only after submitting a 510(k) and receiving an FDA decision of “not substantially equivalent” to a predicate device. Following submission of the De Novo request, FDA would then decide whether to classify a device from a Class III to Class I or II with a new classification/regulation.

Scenarios Under Which a Device Manufacturer Can Obtain a De Novo Classification

There are two scenarios when device manufacturer can obtain a de novo classification. In both the cases, the company must ask the FDA to evaluate whether the device is a class I or II device based on its risks.

  • Under the first scenario, the device manufacturer submits a pre-submission to the FDA. The FDA then provides feedback on whether the de novo process is appropriate. If the de novo mechanism is appropriate, the FDA provides information on the documentation necessary to submit a de novo application. Approval of a device via this method depends on whether the device manufacturer has conducted an effective search for an equivalent currently-marketed device, determined the risks and identified mechanisms to decrease such risks, and collected enough data for the FDA to determine its safety and efficacy.
  • Under the second scenario, a company can obtain a de novo classification by requesting it within thirty days after the FDA has determined that the device is not substantially equivalent. If there is no substantially equivalent device upon which to decide, the sponsor can ask the FDA to determine whether the mechanism is appropriate without submitting a 510(k) application.

How to Submit a De Novo Request

De novo requests should be submitted in an electronic format (eCopy). Once a De Novo request is received by the FDA, any submission or copies are not returned to the applicant. Hence, requests should be sent to the appropriate Document Control Center (DCC). The mailing address for CDRH’s(Center for Devices and Radiological Health) 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.

De novo request should be submitted to FDA that will provide a signed receipt of delivery. When CBER or CDRH receives a De Novo request, the appropriate Center assigns the request a unique document number. The De Novo number always 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.

FDA Review & Timeline

  1. Once it receives a de novo request, the FDA will verify another submission for the same device from the same requester, which is not under review.
  2. Post verification, 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 if your device is eligible for de novo classification or not.
  4. After the classification review is complete, the FDA will begin the substantive review of the de novo request. During the review, the lead reviewer may identify deficiencies that can be accurately 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 AI letter will be sent to the applicant. Then the submission will be 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.

The de novo Classification is necessary for manufacturers to ensure the safety of end-users. Where does your device fit? To get the customized information and Regulatory support regarding the de novo classification, speak to us at sales@freyrsolutions.com.