Glossary · USA: FDA device and drug rules
FDA premarket pathways: 510(k), De Novo and PMA
Also known as: 510(k), Premarket notification, De Novo classification request, Premarket approval (PMA), FDA device classes I, II and III
The FDA premarket pathways are the routes by which a medical device reaches the US market. A 510(k) shows substantial equivalence to a legally marketed predicate device, a De Novo request classifies a novel low- or moderate-risk device without a predicate, and premarket approval (PMA) is required for most class III devices on the basis of valid scientific evidence of safety and effectiveness.
- USA
In one sentence
FDA device routes: 510(k) shows substantial equivalence to a predicate, De Novo covers novel low/moderate-risk devices, PMA is for class III devices.
Example
A startup's AI-based wound imaging software has no suitable predicate, so it files a De Novo request; once granted, the new device type becomes a possible predicate for later 510(k) submissions by competitors.
How it applies
- Device classes: FDA classifies devices as class I, II or III by risk, largely through classification regulations by device type. The class usually determines the pathway.
- 510(k): The most common route for class II devices. The submission compares intended use and technological characteristics with a predicate device and shows that differences don't raise different questions of safety and effectiveness. Many class I and some class II devices are exempt from 510(k).
- De Novo: For novel devices of low or moderate risk for which general controls, or general and special controls, provide reasonable assurance of safety and effectiveness. A granted De Novo creates a new classification regulation.
- PMA: The most demanding route, usually requiring clinical data, for class III devices that support or sustain life or present a potential unreasonable risk. Approval is product-specific, and later changes can need PMA supplements.
- Planned changes: For devices with software, especially AI, a predetermined change control plan can be authorized with any of these submissions.
- Technical documentation: Each pathway has its own submission content; FDA expects the design controls and records behind it to be maintained under the QMSR.
FDA premarket pathways vs. EU conformity assessment
In the USA, FDA itself reviews and clears or approves devices before marketing (except exempt devices). In the EU, the manufacturer carries out conformity assessment and, for most classes, a notified body certifies it before the manufacturer affixes the CE marking. The classes don't map one to one: MDR has 22 classification rules and four main classes, FDA classifies by device type.