Two of the most common US pathways for low-to-moderate-risk medical devices are the 510(k) and the De Novo request. Picking the right one early shapes your testing plan, timeline, and budget.
The deciding question: is there a predicate?
- 510(k) works when a legally marketed predicate device exists that shares your device’s intended use and technological characteristics. You demonstrate substantial equivalence rather than proving safety and effectiveness outright.
- De Novo is for novel devices of low-to-moderate risk that have no suitable predicate. Without a predicate, a device would otherwise default to Class III (the highest risk class); De Novo provides a route to classify it into Class I or II based on a benefit-risk and special-controls evaluation.
If a strong predicate exists, 510(k) is usually faster and cheaper. If your device is genuinely novel, forcing a weak predicate often backfires, and De Novo may be the correct path.
What each pathway requires
510(k): device description, predicate comparison and substantial-equivalence argument, performance testing, labeling, and risk management, submitted via the eSTAR template. FDA’s review goal is roughly 90 FDA days.
De Novo: a more detailed submission including a risk-benefit analysis, identification of probable risks and the special controls that mitigate them, and supporting performance (and sometimes clinical) data. Review takes longer than a typical 510(k), but a granted De Novo creates a new device type, and your device can then serve as a predicate for future 510(k)s, including competitors’.
A strategic angle
A granted De Novo can be a competitive moat: you define the device type and the special controls, and you reach the market first. But it demands a more rigorous evidence package. The right call comes from an honest predicate search and a clear-eyed read of your risk profile.
Choosing the pathway is a strategy decision, not a form. Sequence Group runs the predicate analysis, recommends the pathway, and authors the submission. Get in touch.