Introduction to Major Pathways
Before medical devices in the United States are introduced to the market, they must first be approved by the Food and Drug Administration (FDA). The FDA uses several different pathways to approve products varying in risk and innovation levels. The three main pathways include 510(k) clearance, De Novo Classification, and Premarket approval (PMA). For lower-risk devices, exemptions may be granted, while some Class III devices receive a Humanitarian Device Exemption. In some special cases, unapproved devices are made allowance for emergency or compassionate use.
510(k) Premarket Notification
The 510(k) pathway is one of the most common pathways medical devices follow for FDA approval; a 510(k) must be submitted for all devices that do not require a PMA, with the exception of devices granted an exemption. Following the pathway, Manufacturers must provide evidence proving their device is “substantially equivalent” to a device already in the market, also known as a predicate device. A 510(k) is often associated with lower-to-moderate risk devices.
De Novo Classification
Similar to the 510(k), De Novo classification is used for low or moderate-risk devices; however, a De Novo is used when no predicate, or similar, device already exists in the market. In this case, the evidence of safety and effectiveness of the device is reviewed by the FDA. If granted, the device creates a new category that can be referenced in the future by other devices through a 510(k).
Premarket Approval (PMA)
For Class III devices, due to the high-risk level, Premarket Approval is required. PMA differs from the previously discussed pathways as it requires extensive evidence, including clinical studies, non-clinical laboratory, and technical sections of evidence. This is the most time-intensive and costly pathway, but it ensures the highest-risk devices meet the strict safety standards.
Exempt Devices
Many lower-class devices, Class I and Class II, are granted exemption from a 510(k) submission and possibly other pathways. This occurs when the FDA does not require a 510(k) to provide proper evidence of the safety and effectiveness of a device.
Humanitarian Device Exemption (HDE)
For rare diseases affecting fewer than 8,000 people in the U.S. each year, companies can pursue a Humanitarian Device Exemption. This is similar to PMA, but requires less evidence. HDE approval only requires that probable benefits outweigh risks. This pathway simplifies innovation for small patient populations.
Emergency and Compassionate Use
In the case of an emergency, the FDA allows the use of unapproved devices or products, or when no alternatives are present.
Conclusion
The FDA tailors its review system to match the risk and purpose of each device. 510(k) supports gradual improvements, De Novo enables unique but safe designs, and PMA protects patients with high-risk technologies. Exemptions, HDE, and emergency pathways provide flexibility for low-risk devices, rare conditions, or urgent cases. Together, these routes ensure patients gain access to safe, effective, and innovative medical devices while maintaining strong protections for public health.
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