Approval Through FDA’s De Novo Pathway:  A Major Accomplishment!

By Michael Jaasma, PhD, Co-founder and Chief Scientific Officer at Osteoboost Health

In January 2024, Osteoboost achieved a notable regulatory milestone by receiving De Novo classification from the U.S. Food and Drug Administration (FDA). This designation is significant not only because FDA approval is a rigorous process but also because Osteoboost was only the 14th medical device ever granted De Novo approval by the Orthopedic Panel in the FDA’s Center for Devices and Radiological Health (CDRH). This distinction underscores both the innovation and the clinical validation behind Osteoboost.

Understanding the FDA’s De Novo Pathway

People often ask us how the De Novo pathway differs from other FDA regulatory routes, such as 510(k) clearance and Premarket Approval (PMA). The key distinction lies in device classification, risk level, and novelty. But across all pathways, the FDA must determine that a medical device is safe and effective for its intended use.

• Premarket Approval (PMA) is reserved for high-risk (Class III) devices and is the most stringent pathway. It typically requires extensive clinical trial data to demonstrate safety and effectiveness. Some common examples of PMA devices are pacemakers, coronary stents, and joint replacement devices made from new materials.
• 510(k) clearance applies to moderate-risk (Class II) devices that can demonstrate substantial equivalence to a predicate device (a previously FDA-cleared device with the same intended use). 510(k) clearance usually does not require clinical data. Some common examples of 510(k) devices are bone screws, insulin pumps, surgical instruments, CPAP machines, and oxygen concentrators.

Before 1997, an innovative medical device without a predicate—regardless of risk level—was required to undergo the PMA process, even if it posed only moderate or low risk. Recognizing that this regulatory bottleneck could stifle medical innovation, Congress established the De Novo pathway for novel, lower-risk (Class I and II) devices. While the De Novo process is generally less burdensome than the PMA pathway, it still typically requires robust scientific evidence, such as clinical trial data, to demonstrate both safety and effectiveness.

As the numbers show, 510(k) submissions are by far the most common. In 2023, the FDA authorized:

• 3326 510(k)s
• 47 De Novos
• 36 PMAs

Osteoboost: A New Category

Osteoboost’s journey through the De Novo pathway required approximately one year of rigorous evaluation by the FDA, including a comprehensive review of our clinical trial data and engineering performance testing. Because Osteoboost represents a completely new category of medical device, there were no established regulatory precedents or standardized test methods for us to rely on. This meant that the FDA’s review process was especially thorough, ensuring that Osteoboost met the highest standards for safety and effectiveness before it was granted clearance. Specifically for effectiveness, the clinical trial results were required to demonstrate that Osteoboost provides a clinically meaningful and statistically significant benefit over standard of care. 

To quantify the benefits of Osteoboost’s targeted vibration therapy on bone strength and bone density, we partnered with a team of top research experts at the University of Nebraska Medical Center to conduct a gold-standard clinical trial: a randomized, sham-controlled trial. This ensured the highest level of clinical evidence and provided the FDA with the high-quality data required for the De Novo pathway.

Receiving FDA De Novo approval is a testament to the scientific innovation and clinical impact of Osteoboost. It affirms that our technology is a safe, evidence-based, and effective option for individuals seeking an early, non-drug intervention for low bone density. We are proud to bring this breakthrough to patients and look forward to advancing the future of bone health.