De Novo Request Helps Bring Low and Medium Risk Devices to Market

Inquiry

De Novo is an approach for the FDA to classify novel medical devices based on risk for devices whose safety and effectiveness can be ensured through general controls or specific controls (i.e., low and moderate risk).

De Novo provides both a pathway to bring innovative devices to market and establishes a new classification standard that will inform the marketing of similar devices in the future. In this article, we will provide an overview of the De Novo request and the application process.

What Is De Novo?

De Novo is a way used by the FDA to regulate the marketing authorization of certain novel medical devices. These medical devices cannot demonstrate relative safety and efficacy through the 510(k) process because there is no legally marketed substantial equivalent, and the risk of these devices is not high enough to warrant the use of the premarket approval (PMA) process. This pathway is therefore designed for low to moderate risk medical devices that lack an equivalent product.

Medical devices that successfully pass the De Novo review will be classified by the FDA as Class I or Class II medical devices and provide a new benchmark for equivalents for future marketing of similar devices.

De Novo fills an important gap in medical device regulation by allowing products that are innovative but do not fit into the 510(k) pathway to enter the marketplace as quickly as possible while ensuring public health and safety.

De Novo Request Content Requirements

The required content elements of a De Novo request are listed in Appendix A of the relevant guidance document.

FDA requires that the De Novo request contain the following elements:

Coversheet: A coversheet that clearly identifies the request as "Request for Evaluation of Automatic Class III Designation"
Administrative: e.g., intended use of the device, prescription use, or designated over-the-counter use, etc.
Device description: including but not limited to, technology, recommended conditions of use, accessories, and components
Classification information and supporting data

Submission Methods and Fees

Online submission

Submit online via the CDRH portal by sending an eSTAR or eCopy.

eCopy mailing address

U.S. Food and Drug Administration

Center for Devices and Radiological Health

Document Control Center (DCC) - WO66-G609

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

Within 7 days of acknowledging receipt of a De Novo request, the appropriate FDA agency will provide an acknowledgement letter, including the De Novo number.

De Novo related official fees.

FDA Review Process for De Novo

The FDA review process for De Novo requests includes a thorough risk assessment of the medical device to determine its safety and effectiveness.

Pre-submission

FDA recommends, but does not require, that applicants submit a pre-submission before formally submitting a De Novo request. A pre-submission allows the applicant to obtain early feedback from FDA on the classification of the product and recommendations for submitting a De Novo request.

Acceptance review

Upon receipt of a De Novo request, FDA will conduct an acceptance review. This review is an administrative review that evaluates the completeness of the request and whether the minimum thresholds for acceptability have been met.

If any element is missing, FDA has grounds not to move forward with the request. To assist in the completeness review, FDA recommends that the applicant complete and submit an acceptance checklist.

Within 15 calendar days of the DCC's receipt of a De Novo request, FDA will electronically notify the requestor of the acceptance review results, and typically FDA's feedback includes the following types of results:

De Novo request has been accepted for substantive review
The De Novo request is not accepted for review (Refuse to Accept, RTA) and the applicant has 180 calendar days to process the RTA notification
De Novo request is undergoing substantive review and FDA does not complete a completeness review within 15 calendar days

Substantive review

As part of the substantive review, FDA conducts a categorical review of the types of legally marketed devices and analyzes whether there are existing legally marketed devices of the same type to confirm that the device qualifies for a De Novo request.

During the substantive review of a De Novo request, FDA may identify deficiencies that can be adequately addressed through interactive review without a formal request for additional information.

If the issues and deficiencies cannot be resolved through interactive review, a Supplemental Information Letter will be sent to the requester and De Novo will be placed on hold. The requestor has 180 calendar days from the date of the letter to submit a complete response to each item in the Supplemental Information Letter.

FDA plans to make a final decision on the De Novo request within 120 calendar days. Review days are calculated from the date FDA receives the De Novo request to the date of FDA's decision, and do not include days when the request is suspended due to a request for additional information.

De Novo Application Process

Proregulations offers comprehensive De Novo application services for medical device companies. If you are interested in our services or need more details, please contact us.