What is De Novo?

The De Novo classification process is a regulatory pathway for low-to-moderate-risk medical devices that are not similar to any legally marketed device. This pathway allows companies to bring new and innovative medical devices to market. This pathway is for devices that have a novel design or intended use and have not been classified under existing regulations.

What is a De Novo Classification Request

A De Novo classification request is a submission made to the FDA by a medical device manufacturer seeking to classify their device into the De Novo classification pathway. This request must include information that demonstrates the device’s safety and effectiveness and how it is different from legally marketed devices.

  • A De Novo classification request must include information on the device’s design, intended use, and performance data.
  • The manufacturer must also provide evidence that the device is low-to-moderate-risk and not similar to any legally marketed device.
  • Once the FDA receives the request, they will review the information provided and make a determination on the device’s classification and regulatory pathway.

When to prepare a De Novo classification request?

Preparing a De Novo classification request is appropriate for low-to-moderate-risk medical devices that are not similar to any legally marketed device. It may be appropriate to prepare a De Novo classification request when a device is the first of its kind, or if it is intended to be used in a new way that was not previously seen in the market. It’s important to consult with a regulatory expert like Innovenn to initiate collaboration with the FDA through the presubmission process to determine if a De Novo classification request is appropriate for your medical device.

What to include in a De Novo request?

When preparing a De Novo classification request, it is important to ensure that all necessary information is included. The FDA has specific requirements for the content and format of the request. The following sections must be included in the request in order to be considered for review: Cover sheet, Administrative information, Device description, and Classification information. Each of these sections has detailed documentation that is required and will be thoroughly reviewed by the FDA during the De Novo review process. Accurate and complete information in these sections is required in order to increase the chances of a successful classification.

Cover sheet

The cover sheet should include the contact information of the device manufacturer and a brief summary of the device being submitted for classification.

Administrative information

The administrative information should include the device’s trade name, common name, and any other identifying information as well as the intended use of the device.

Device description

The device description should provide a detailed description of the device, including its physical characteristics, components, and any associated software or accessories.

FDA Review Process and Timeline

The FDA review process for a De Novo classification request can vary in length, depending on the complexity of the device and the completeness of the submission. It is important to understand the different stages of the review process and what to expect in terms of timelines. In this section, we will break down the key steps of the FDA review process, including submission and receipt of the De Novo request, technical review and classification decision, notification of decision and next steps, and the appeal and reconsideration process.

Submission and receipt of De Novo request

The first step in the FDA review process is the submission and receipt of a De Novo request. This can be done electronically through the FDA’s electronic submission portal, or by mail. Once received, the FDA will review the submission to ensure it is complete and contains all necessary information.

Technical review and classification decision

After the submission is deemed complete, it will undergo a technical review by FDA staff. This will include a review of the device’s design, manufacturing processes, and any relevant clinical data. Based on this review, the FDA will make a classification decision, determining the appropriate regulatory pathway for the device.

Notification of decision and next steps

The FDA will notify the device sponsor of the classification decision and any next steps required for the device to come to market. This may include additional testing, labeling requirements, or post-market surveillance.

Appeal and reconsideration process

If a device sponsor disagrees with the FDA’s classification decision, they may request an appeal and reconsideration of the decision. This process allows for further review and discussion of the device’s classification, and may lead to a change in the initial decision.

Why Us?

At Innovenn, we have extensive experience navigating the De Novo classification process and can help guide your company through the submission process. Our team of experts includes former FDA reviewers who have a deep understanding of the agency’s requirements and can provide valuable insights into how to strategically position your device for success.