510(k), De Novo and PMA: Start with the Device Route

Last reviewed: 2026-10-03

A US medical-device project should begin with the device’s intended use, classification and regulatory status. 510(k), De Novo and PMA are different pathways; they are not interchangeable packages selected by the cheapest fee or shortest advertised timeline.

Three different purposes

A 510(k) generally addresses substantial equivalence to an appropriate legally marketed predicate. A successful outcome is clearance. De Novo provides a classification pathway for certain novel devices where its criteria are met. PMA is a separate approval pathway associated with Class III devices and evidence of safety and effectiveness.

Plan evidence after route review

The route affects the relevance of comparison information, performance evidence and other documentation. Existing reports should be assessed for the specific device and intended submission use. A previous submission for another product is not automatically a suitable template.

Keep responsibilities clear

FDA makes regulatory decisions. A consultant or coordinator can support agreed workstreams but cannot guarantee clearance, classification or approval. Registration and listing are separate concepts and should not be presented as product clearance.

ConformArc coordinates specialist route and evidence planning where delivery is confirmed. Start with a project review or the Medical Devices hub. A project review is the starting point, not a promise that a particular pathway is suitable.

References: FDA 510(k), De Novo and PMA.