FDA introduces final guidance on the STeP program

The US Food and Drug Administration (FDA) has published final guidance on its Safer Technologies Program (STeP), a new voluntary pathway that aims to bring innovative medical devices and device-led combination products to the US market more quickly. The agency says it will begin accepting applications from interested manufacturers on 8 March 2021.

STeP is modeled on the Breakthrough Devices Program, which provides an accelerated development pathway for devices that promise to provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

STeP, on the other hand, is for devices and device-led combination products that would otherwise go through the PMA, 510(k) or de novo pathways that aim to treat less serious conditions than those accepted for the Breakthrough program, specifically for devices intended to target “diseases or conditions that would be considered non-life-threatening or reasonably reversible,” the guidance explains. Manufacturers using STeP will benefit from “interactive and timely communications, early engagement on Data Development Plans (DDPs), sprint discussions, and senior management engagement,” the guidance continues.