The three premarket pathways
FDA's premarket routes scale with risk and novelty. The 510(k) route clears devices that are substantially equivalent to an existing legally marketed device. De Novo creates a new classification for novel low-to-moderate risk devices with no predicate. PMA is the full scientific review for high-risk devices that support or sustain life.
| 510(k) | De Novo | PMA | |
|---|---|---|---|
| When it applies | A predicate with the same intended use exists | Novel, low-to-moderate risk, no predicate | Class III, highest-risk devices |
| Core standard | Substantial equivalence | Reasonable assurance of safety and effectiveness via special controls | Reasonable assurance of safety and effectiveness, usually with clinical trials |
| Typical evidence | Bench, software, sometimes limited clinical data | Bench plus targeted clinical performance | Pivotal clinical trial program |
| Review clock (FDA days) | ~90 | ~150 | ~180+ |
| Outcome | Clearance to market | Granting creates a new regulation and product code | Approval |
FDA-day targets exclude applicant response time; real-world timelines run longer when review cycles add information requests.
A decision framework
- Start with the product code: its class and submission-type flags narrow the field immediately.
- If your code shows a 510(k) pathway, confirm a predicate whose intended use statement actually covers yours.
- If no predicate exists but risk is low-to-moderate, De Novo is usually the intended route — check whether a similar device already created a category via De Novo.
- If the category is Class III or the device is life-sustaining, plan for PMA and its clinical-evidence program from day one.
- When the classification itself is uncertain, use a 513(g) request or a Q-Submission meeting to get FDA's view before committing.
Evidence and effort, honestly compared
The submission fee is the smallest part of the difference. The real cost is evidence: a 510(k) can often be built on bench and software verification testing against recognized standards; De Novo adds clinical performance evidence proportionate to a novel risk profile; PMA typically requires a pivotal clinical trial with its own multi-year budget.
Special controls deserve attention in the middle routes. A De Novo granting defines special controls for the new category, and many Class II codes carry guidance documents that function as de facto requirements — read them before designing your testing plan.
Notes for software and AI devices
- Software functions that fall outside the section 520(o) exclusions follow the same three routes, classified by the risk of the condition they address.
- AI/ML devices add lifecycle questions: performance across subgroups, transparency, and how model updates will be controlled after authorization.
- Predetermined change control plans can let an authorized AI device update within an agreed envelope without a new submission.
Frequently asked questions
Can I switch pathways mid-program?
Yes, and it happens most often when a 510(k) receives an NSE decision and the sponsor converts to De Novo. Planning for that contingency — designing evidence that serves both routes — avoids repeating studies.
Is De Novo faster than PMA?
Substantially. De Novo targets novel low-to-moderate risk devices and avoids the pivotal-trial scale of most PMA programs, though it still demands credible clinical performance evidence.
What about exempt devices?
Many Class I and some Class II devices are 510(k)-exempt: they can be marketed after registration and listing without a premarket submission. Exemption removes the submission, not the quality-system, labeling or reporting obligations.
How does MedTechCompass choose between them?
The Regulatory Analyzer weighs your device description against classification data, predicate history and category risk signals, then recommends a primary pathway with the reasoning and citations shown so you can challenge or confirm it.
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This article is educational content from CAHIR Solutions and is not legal or regulatory advice. Regulatory decisions depend on your specific intended use and claims — confirm them with FDA resources, a qualified consultant, or a pre-submission meeting before filing.