Guidance on De Novo Classification Requests

A De Novo classification request provides a marketing pathway for novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use. This pathway is utilized when there is no legally marketed predicate device. The De Novo classification is a risk-based process that allows these novel devices to be classified into class I or class II.

Purpose

The purpose of a De Novo request is to establish a new device classification, which can subsequently serve as a predicate for future premarket notification [510(k)] submissions.

Regulatory Framework

The FDA has issued a final rule to establish new regulations for the De Novo classification process under the FD&C Act (section 513(f)(2) (21 U.S.C. 360c(f)(2)). This rule outlines the criteria for De Novo classification requests, including the requirements for the format and content of the requests, as well as the processes and criteria for accepting, granting, declining, and withdrawing De Novo requests.

When to Prepare a De Novo Request

There are two scenarios under which a De Novo request may be submitted:

After Receiving an NSE Determination: If a device receives a high-level not substantially equivalent (NSE) determination (indicating no predicate, new intended use, or different technological characteristics that raise new questions of safety and effectiveness) in response to a 510(k) submission.

No Legally Marketed Device: When the requester determines that there is no legally marketed device upon which to base a determination of substantial equivalence, and thus, submits a De Novo request without first submitting a 510(k).

How to Prepare a De Novo Request

Before submitting a De Novo request, sponsors are encouraged to submit a Pre-Submission to obtain feedback from the appropriate premarket review division. The following steps outline the preparation of a De Novo request:

Pre-Submission: Consider submitting a Pre-Submission to receive early feedback from the FDA. This step is highly recommended to clarify any uncertainties and align with FDA expectations.

Content and Format: Ensure the De Novo request includes the required content and follows the format specified by the FDA. Key elements typically include:

• Device description
• Proposed indications for use
• Summary of the risks to health and mitigation measures
• Description of the device's technology
• Performance data
• Administrative information

Risk-Based Evaluation: The FDA will perform a risk-based evaluation to classify the device into class I or class II based on the information provided in the De Novo request.

Submission: Submit the De Novo request to the FDA, ensuring all necessary documentation and supporting information are included.

Review Process: The FDA will review the De Novo request and make a determination. This may involve additional requests for information or clarification from the requester.

Acceptance, Granting, Declining, and Withdrawal

The FDA’s final rule provides detailed criteria for the acceptance, granting, declining, and withdrawal of De Novo requests. Understanding these criteria is essential for preparing a robust De Novo request. The decision-making process will consider the following:

• Completeness of the submission
• Adequacy of the data provided
• The risk profile of the device
• The effectiveness of the proposed controls

The De Novo classification process is a critical pathway for novel medical devices to obtain market authorization. By following the regulatory requirements and preparing a comprehensive De Novo request, sponsors can facilitate the FDA’s risk-based evaluation and potentially expedite the classification and marketing of their devices.

Author.: Akash Kirani