Understanding FDA 510(k) vs. De Novo: Which Pathway is Right for Your Medical Device?
Bringing a medical device to market in the U.S. requires FDA approval, but not all devices follow the same regulatory path. The 510(k) and De Novo pathways are two primary routes startups must consider. Choosing the right one depends on factors such as device novelty, risk classification, and regulatory precedents.
What is the 510(k) Pathway?
The 510(k) clearance process is designed for moderate-risk devices (Class II) that have a substantially equivalent (SE) predicate device already on the market. If a new device is similar in intended use and technological characteristics to an existing, legally marketed device, it may qualify for 510(k) submission.
Key Points:
✅ Faster Approval – Typically reviewed within 90 days.
✅ Lower Cost – Less expensive than the De Novo or PMA process.
✅ Predicate Requirement – Must prove equivalence to a device already cleared.
When to Use It:
Your device has a legally marketed predicate device with similar indications.
Your technology doesn’t introduce significant risks beyond existing products.
You need a faster market entry with a lower regulatory burden.
What is the De Novo Pathway?
The De Novo process is intended for novel, moderate-risk (Class I or II) devices that have no predicate but still pose a low-to-moderate risk. If your device was previously rejected for 510(k) due to a lack of a predicate, you may need to pursue De Novo classification.
Key Points:
✅ No Predicate Needed – Designed for innovative devices.
✅ More Regulatory Scrutiny – Requires comprehensive risk and safety data.
✅ Longer Review Process – Typically takes 150+ days for FDA evaluation.
When to Use It:
Your device has no legally marketed equivalent but still falls under Class I or II.
You have strong clinical and technical data to support safety and effectiveness.
You want to establish a new regulatory category for future similar devices.
510(k) vs. De Novo: Which One Should You Choose?
Conclusion
Choosing the right FDA pathway depends on whether a predicate device exists and the level of risk associated with your product. 510(k) is ideal for devices with market precedents, while De Novo suits truly novel innovations. Medical startups should carefully evaluate their regulatory strategy early to avoid unnecessary delays and costs.
About The Author
Darrell Drysen has over 25 years of experience in the Medical Device, Life Science, and Bio-Tech industries. As a technical leader, he holds patents in several fields including Brachytherapy, Electrophysiology, and Neurovascular implants. His outstanding ability to lead projects is evident from the numerous products he has taken from from concept through commercialization for both large companies and starts-ups. He joined ThermoGenesis in 2019 and is currently the Vice President of Operations.
Darrell holds certificates and degrees in Plastics Engineering Technology, Project Management, and Business Administration from California State University Sacramento and Cal Poly Pomona.
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