Understanding FDA Premarket Pathways
Before any medical device can be legally marketed in the United States, the manufacturer must receive market authorization from the FDA. The pathway depends on the device's classification, risk level, and whether a substantially equivalent device already exists on the market.
The Three Main Pathways
510(k) Premarket Notification
The 510(k) pathway is the most common route, accounting for the majority of device clearances annually. It requires demonstrating that your device is substantially equivalent to a legally marketed predicate device.
Best for: Class II devices (and some Class I) with an existing predicate.
Timeline: Approximately 3–6 months for preparation, plus 90 days for FDA review.
De Novo Classification
The De Novo pathway is designed for novel, low-to-moderate risk devices that have no legally marketed predicate. It creates a new classification and can serve as a predicate for future 510(k) submissions.
Best for: Novel Class I or Class II devices without a predicate.
Timeline: 6–12 months preparation, plus approximately 150 days for FDA review.
PMA (Premarket Approval)
PMA is the most rigorous pathway, required for Class III high-risk devices. It demands valid scientific evidence — typically including clinical trial data — demonstrating safety and effectiveness.
Best for: Class III high-risk devices (e.g., implants, life-sustaining devices).
Timeline: 12–24+ months, including clinical studies and 180-day FDA review.
How to Choose the Right Pathway
- Classify your device using the FDA Product Classification Database
- Search for predicates — if a substantially equivalent device exists, 510(k) is likely your path
- Assess risk level — novel low-risk devices may qualify for De Novo
- Evaluate clinical data needs — if Class III, prepare for PMA
Need Help Choosing?
United Regulatory specializes in FDA device classification and pathway selection. Contact us for a free regulatory strategy consultation.