Guide
FDA regulatory pathways: 510(k), De Novo, and PMA
The route a device takes to the US market follows from its classification and risk profile. Choosing the route is not a formality — it sets the evidence you need, the time you will spend, and the cost of getting it wrong.
Classification comes first
The FDA classifies devices into three classes by risk. Class I devices are lowest risk and most are exempt from premarket notification. Class II devices are moderate risk and typically reach market through 510(k) premarket notification. Class III devices support or sustain life or present potentially unreasonable risk, and generally require premarket approval.
Classification depends on the intended use and indications for use as written, not on the technology in isolation. Small wording changes to intended use can move a device between routes.
The three main routes
Each route trades evidence burden against time and certainty.
- 510(k): demonstrates substantial equivalence to a legally marketed predicate device. Usually the fastest route when a suitable predicate exists.
- De Novo: for novel devices of low to moderate risk with no predicate. It creates a new classification that later devices can use as a predicate.
- PMA: the most demanding route, generally requiring clinical data demonstrating reasonable assurance of safety and effectiveness for Class III devices.
Comparing routes before you commit
The predicate search is where most 510(k) strategies are won or lost. A predicate with a close intended use shortens the submission considerably; a stretched comparison invites additional information requests that cost more time than the original route would have.
It is also worth evaluating the US route alongside EU MDR and UKCA rather than sequentially. Evidence generated for one jurisdiction often partly satisfies another, and knowing that before a study is designed avoids duplicated clinical work.
MedTech Compass runs that MedTech regulatory triage for you: it compares global FDA pathways — 510(k), De Novo, and PMA — against EU MDR and UKCA requirements for the same device, and pairs each route with multi-dimensional market scoring and payment forecasting so the trade-off is visible in one view.
Once a route is chosen, MedTech Copilot acts as AI medical device documentation and MedTech QMS software, turning submission evidence into automated design history files and audit-ready records.
Frequently asked questions
- How long does a 510(k) take?
- Timelines vary widely by device, submission quality, and whether the FDA issues additional information requests. Published FDA performance data is the right source for current averages; a specific device should be planned against its own classification and predicate situation rather than an average.
- What if there is no predicate device?
- De Novo is the route intended for novel low-to-moderate-risk devices with no predicate. It requires a risk-based justification of classification rather than an equivalence argument.
- Does software count as a medical device?
- Software can be regulated as a device when its intended use is diagnosis, treatment, or clinical decision-making. The determination turns on intended use and the degree of clinical decision support, so it should be assessed for the specific product claims.