FDA pathway picker

FAQ

What is the difference between a 510(k), De Novo and PMA?

A 510(k) (premarket notification) shows your device is substantially equivalent to a legally marketed predicate; it is the usual route for Class II and some Class I devices. De Novo is a risk-based classification request for novel low-to-moderate risk devices with no valid predicate; if granted, it creates a new classification and the device can serve as a predicate for future 510(k)s. PMA (premarket approval) is the most stringent route, required for most Class III devices, and needs valid scientific evidence of reasonable assurance of safety and effectiveness.

How do I find my device’s FDA classification and product code?

Search FDA’s Product Classification database by device name or regulation number. Each product code lists the device class, the classification regulation, whether the device is 510(k)-exempt, and the review panel. If the classification is genuinely unclear, a 513(g) request for information asks FDA for its view on classification and applicable requirements.

What is a predicate device and substantial equivalence?

A predicate is a legally marketed device you compare against in a 510(k). Substantial equivalence means your device has the same intended use as the predicate and either the same technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness and are supported by data showing it is as safe and effective.

Are all Class I devices exempt from 510(k)?

No. Most Class I devices and some Class II devices are 510(k)-exempt, but exemptions have limitations spelled out in the classification regulations, and some Class I devices are reserved and still need a 510(k). Exempt devices must still meet general controls such as establishment registration, device listing, labeling, and applicable quality system requirements.

When should I use an FDA Pre-Submission (Q-Sub)?

The Q-Submission program lets you request written feedback, and optionally a meeting, from FDA before a marketing submission. Teams typically use it when the pathway, predicate choice, testing strategy, or clinical study design is uncertain. It is voluntary, and FDA feedback is not a clearance or approval decision.

Does this tool decide my regulatory pathway?

No. It gives an educational working hypothesis from four inputs. Your actual pathway depends on the product code, intended use, predicates, and FDA’s view, so confirm on the FDA classification database and with qualified regulatory counsel.