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.
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:
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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.
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:
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:
Overall, for the right device and technology, the de novo pathway is faster and easier than a 510(k). 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.
David Jensen is a marketing communication specialist at MasterControl. He has been writing technical, marketing and public relations content in technology, professional development, business and regulated environments for more than two decades. He has a bachelor’s degree in communications from Weber State University and a master’s degree in professional communication from Westminster College.