De Novo Becoming Faster and Easier Pathway to Market

There are many pathways medical device manufacturers can use to bring a device to market. The 510(k) and premarket approval (PMA) are among the more popular routes, while the de novo pathway has not been used as much. One reason is the de novo pathway originally required device manufacturers to complete a 510(k) application before pursuing the de novo route. Recent updates to the regulatory requirements allow companies to pursue a de novo without a prior 510(k) submission. This not only makes the de novo pathway faster and easier than a 510(k), it encourages manufacturers to be more innovative.

The De Novo Pathway in Brief

Historically, if a company developed a new medical device that was not based on a similar device (no substantial equivalent), the U.S. Food and Drug Administration (FDA) automatically categorized the device as Class III – regardless of the nature of the device. It could be an adhesive patch and it would still be classified in the same category as an implantable device that requires an extensive PMA process. This usually turned into a cumbersome, back-and-forth correspondence with the FDA, which could go on for well over 200 days. The industry needed a better mechanism, so the FDA created the de novo pathway.

The de novo pathway was designed to enable manufacturers to get their unique, low-risk devices on the market faster and more efficiently. However, the initial de novo process was neither fast nor efficient. There were hoops – and lots of them. Before pursuing a de novo, medical device manufacturers were required to:

1. Complete a full 510(k) application.
2. Wait for the FDA to determine that a substantial equivalent device did not exist and reject the 510(k) application based on that finding.
3. Submit a de novo application to down-classify the device.
4. Wait for the FDA to determine if the device qualified for a lower-risk, Class II or Class I category.

If the device failed to achieve a down-classification due to its risk status, it remained a Class III device and required a PMA. Needless to say, the de novo pathway wasn’t winning any popularity contests.

A Modernized De Novo

In 2012, modifications to the US Food, Drug and Cosmetics Act (FDCA) allowed manufacturers of low-risk devices to request a de novo classification without first submitting a 510(K). In addition, the turnaround time for the FDA review was set at 120 days. This made the de novo a more attractive regulatory option for medical device companies.

Keys to De Novo: Substantial Equivalence and Risk Mitigation

While the de novo pathway is a faster track to regulatory approval, how fast a company gets to market depends on its level of preparedness to navigate the regulatory pathway. One of the main benefits of the de novo is fewer exchanges with the FDA. However, manufacturers are still responsible for demonstrating that their device qualifies for a Class II or Class I category, which involves meeting the following requirements: 

• Pathway rationale – Manufacturers must ensure that the device has no substantial equivalent and does not require a 510(k).
• Account for all risks – The de novo pathway is highly risk-based. De novo applicants must establish reasonable assurance of the safety and effectiveness of the device. The manufacturer must confirm that it has identified all risks and can sufficiently mitigate the risks (e.g. probability of harm in using the device or even not using the device, operating errors, etc.).

Is De Novo the Right Pathway for Your Medical Device?

Aside from becoming a faster pathway, the de novo approach presents more opportunities for innovation. Advancing technology is making it easier to demonstrate that a device has no substantial equivalent. Even if your device is similar to an existing device, if the technology is different, you can pursue a de novo classification.

To determine if the de novo pathway is right for your device, it’s important to understand all aspects of the approach, including the advantages and disadvantages. It’s also important to be sufficiently prepared to meet the requirements. Here are a few tips for pursuing the de novo pathway:

• Reach out to the FDA first – This is not required, but it’s recommended that you establish a relationship with your reviewers. This also helps you become more educated about the process.
• Be proactive – Don’t ask or expect the FDA to tell you what to do. Approach the agency with your device and a plan. It’s important for the agency to see the device as you do. Be prepared to present all clinical data. Also, plan to discuss what testing you’re doing, what data you have, and how you are getting your data.
• Prepare as much as possible – Try to fully understand what’s involved with the de novo pathway, what to expect with the review process, and why it’s the best route for your device instead of a 510(k). For example, when a device has a substantial equivalent, there is an underlying assumption of safety and efficacy – that’s not the case with new devices. Make sure you do a full risk assessment and have confidence in your mitigation strategy.

Overall, for the right device and technology, the de novo pathway is faster and easier than a 510(k) submission. The process still has challenges, but it encourages innovation. Advancing technology is creating more opportunities to carve out niches and fulfill unmet needs in health care. The key to a successful de novo is to not just follow the guidelines, but be mindful of your efforts and take advantage of the FDA’s willingness to assist you.