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Understanding the FDA De Novo Approval Process for Novel Medical Devices

If you’re familiar with how the FDA regulates medical devices, you know it hinges on a predicate system. Manufacturers bringing their device to the US market must identify a product already cleared or approved by the FDA that is “substantially equivalent” to their device.

But what if your device has no predicate? Prior to 1997, novel and innovative devices with no valid predicate were automatically ruled Class III devices, regardless of their risk profile. This approach leveled a hefty regulatory burden at ground-breaking products, making it even more difficult to bring new technology to market. Eventually, the FDA recognized that not all new medical device technology deserved to be placed into the high-risk category. Thus, the De Novo classification process was born, providing a path to market for novel devices with lower risk.

In this article, we will discuss eligibility criteria for De Novo classification and shed light on the types of devices that can benefit from this pathway. Furthermore, we will outline the De Novo process step-by-step, from the pre-submission phase to the FDA’s final classification decision.

What is the FDA De Novo Application Process?

Like the FDA 510(k), the FDA De Novo application process is a regulatory pathway for low- to moderate-risk medical devices. However, the De Novo route is only an option for devices that do not have a cleared predicate (substantially equivalent device) in the market. Once a novel product is cleared through the De Novo process, FDA creates a new  regulation and product description and corresponding product code that other manufacturers can leverage to establish equivalence.  The sponsor of a De Novo application is responsible for demonstrating the safety and effectiveness of the device when used in its intended use.  The performance testing conducted on the device becomes the standard (performance controls) subsequent device manufacturers must follow when establishing substantial equivalence for their product.  These devices do not need to re-establish safety when submitting a 510k after the De Novo approval.

Although it’s been in place since 1997, De Novo classification is one of the least-used pathways to the US device market. FDA continues to refine the process and released this guidance in October 2021.

Confirm your Device’s Eligibility for De Novo Classification

If you’re thinking the De Novo route might be the right pathway for your device, the first step is to confirm eligibility. De Novo classification has two main criteria:

  1. There is no predicate device – Some manufacturers learn their device has no predicate after submitting a 510(k) that receives a “not substantially equivalent” (NSE) decision from the FDA. While this feedback is definitive, this should not be a strategy you pursue since preparing a 510(k) is expensive and time-consuming. In 2021, the FDA issued a guidance creating a “direct to De Novo” submission pathway so manufacturers no longer need to receive an NSE to use the De Novo application route.
  2. The device is low to moderate risk – The second criteria for De Novo is a low to medium risk profile (i.e., a Class I or Class II device). You will need to make a case for your device classification in your submission, as well as provide a detailed risk mitigation strategy.

Engage with FDA as Early as Possible

Manufacturers are encouraged to discuss their plans with the FDA before preparing their submission to determine their device eligibility, any potential predicate devices, if clinical data may be required, etc. There are two ways to do this:

  • Request a Pre-Submission meeting, which provides an opportunity to receive feedback from the FDA, discuss the device’s characteristics, potential risks, and the type of data required to support the safety and effectiveness of the device.
  • Submit a 513(g) Request for Classification. This option carries a fee and focuses on finalizing a classification determination from FDA before you prepare your marketing submission.

Prior consultation with the FDA isn’t required for De Novo classification but can be critical to your success when pursuing this pathway. Note that any consultation with the FDA should be disclosed in your De Novo submission, along with the disclosure of any other prior submissions to the FDA (such as a 510(k)) for the device in question.

FDA Review and Decision for De Novo Application Approval

The FDA reviews the De Novo submission application for completeness and accepts (or rejects) it for substantive review within 15 calendar days. For substantive review, the FDA ultimately evaluates whether the device’s safety and effectiveness “can be assured through the application of general controls or general and special controls” and grants De Novo classification, creating a new device category. This classification creates a new regulatory pathway for other manufacturers to follow, as they can use the 510(k) process to demonstrate substantial equivalence to your device and share its product code.

While the FDA targets 150 calendar days to turnaround a De Novo decision, De Novo reviews can take longer than a 510(k) review as they are considering your submission with no precedent for its safety and effectiveness. If you receive an Additional Information (AI) request from FDA about your De Novo submission, the FDA will pause the clock on your submission’s review time. You must respond to the AI request within 180 calendar days or your submission may be deleted.

De Novo Application Checklist

This checklist provides a high-level overview of the key steps and considerations for navigating the FDA De Novo process. However, the process and requirements can vary depending on the specifics of your device, so consult with regulatory professionals and refer to the FDA’s official guidance documents for details.


Sponsor Steps

Key Considerations

Confirm your De Novo eligibility

●        Determine if your device is eligible for De Novo classification (no valid predicate, or previously classified as high-risk under PMA).

●        Request a pre-submission meeting with the FDA to discuss your device, intended use, and potential data requirements.

Prepare a comprehensive submission that includes:

●        Cover sheet identifying the submission as a De Novo request.

●        Device data and description, intended use, indications for use, etc.

●        Classification recommendation and information.

●        Evidence of safety and effectiveness.

●        Clinical data (if applicable).

●        Non-clinical testing data.

●        Performance testing data.

●        Benefit-risk assessment.

FDA review and decision

●        Submit your De Novo application to the FDA.

●        Address any requests for additional information from the FDA within 180 calendar days.

If your De Novo application is approved, your device can be marketed immediately. The FDA will publish a notice in the Federal Register with the new classification designation. FDA may also prescribe special controls for your device type beyond a compliant quality management system and required post-market activities. If you decline your De Novo approval for any reason, your product will remain a class III device.

Ready to Learn More?

The De Novo application process is an underutilized regulatory path that can have clear advantages for the right device. If you’re struggling to identify a predicate for your product but you’re not sure you qualify for De Novo, our consultants can help you move forward. We can investigate potential predicate devices to confirm if your product is eligible for De Novo or a different regulatory route. We will then help you prepare for a productive Pre-Submission meeting with the FDA and compile a thorough De Novo submission.

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