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How to prepare a De Novo Request?

Apr 12 2022

In the United States, successfully launching a product is as important as developing a new medical device.

Let's take a look at the preparations and procedures of De Novo for a successful product launch in the United States.

The De Novo process provides a pathway to bring new devices to market with low to moderate risk. De Novo Submission is not similar to an existing device on the market and it applies to new technology(working principle).

Often there is no distinction between 510(k) and De Novo processes.

If so, What is the difference between those processes?

Both processes are the pathway to the U.S. market of the low to medium risk Class I and Class II. However,

  • A 510(k) is for a product that is "substantially equivalent" to an existing device on the market and must be proven to be accepted for submission.

  • In the De Novo process, there are no "substantially equivalent" products on the market, which is like starting out in a new state.

When and How to Prepare a De Novo Request

There are two options to submit a De Novo request for the FDA to make a risk-based evaluation for the 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 sponsors consider submitting a Pre-Submission to obtain feedback from the appropriate premarket review division.

Although it is not required, receiving feedback from the FDA through Pre-Submission before submitting a De Novo request is very helpful.

A Pre-Sub is a formal written request for feedback from the FDA which requires a meeting with the FDA.

To learn more details about Pre-Sub, read FDA, guidance of Pre-Submission.

What is FDA's Review Process and Timeline for Requests?

Acceptance Review (21 CFR 860.230)

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 an Acceptance Checklist (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 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 (that is, considered refused to accept or RTA) and the requester has 180 calendar days to fully address the RTA notification; or

  • the De Novo request is under substantive review and the FDA did not complete the acceptance review within 15 calendar days.

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